PSY1020 Ezine

EARN 1.
5
ADDICTION & SUBSTANCE USE SCHIZOPHRENIA & PSYCHOSIS PSYCHOSOMATICS
CME
CREDITS
Cannabis: Medicolegal
Issues
Recovery in
Delusional Disorder
The Importance
of Being There
OCTOBER 2020
Peer-Reviewed • Practice-Oriented October 2020 • Vol. XXXVII, No. 10
COMMENTARY
Presidential
Election Anxiety
and the Role of Psychiatry
» H. Steven Moffic, MD
“Without a full spectrum of voices from partisan political elites, though, anxious
citizens in search of protection from threats to their health and way of life may support
charlatans or madmen who offer bodily protection while destroying the body politic.”1
There are plenty of reasons to be anxious about the calling 2020 “the worst year ever.”
T H E V O I C E O F P S Y C H I AT R Y
state of the nation: the coronavirus pandemic, the econo- As if that were not enough, now we have a presi-
my, climate instability, physician burnout, an endless war dential election happening in the midst of partisan
on terrorism, returning to the classroom (or not), and rac- political warfare, civil unrest, and frightening con-
ism, among other societal and personal stressors. All spiracy theories on TV and the internet. The stakes
these major dangers are on top of the still-looming seem sky high, perhaps because the president has so
nuclear risk that could blot out human life on earth in much influence on how we address every other crisis.
virtually an instant. No wonder some individuals are CONTINUED ON PAGE 18
COMMENTARY
Is the Country Experiencing

a Mental Health Pandemic? ISSUE HIGHLIGHTS
» Ronald W. Pies, MD pandemic. (Most of us have our “war
stories” to tell.) For example, a re-
ditions associated with COVID-19.”1
Using validated screening instru- ANXIETY & STRESS
A
s a psychiatrist, I do not need cently released survey from the Cen- ments, the CDC survey found that, DISORDERS
much convincing that millions ters for Disease Control found that 40.9% of 5470 respondents reported Trauma-Informed Approaches
of people are suffering emo- from June 24-30, 2020, adults in the an adverse mental or behavioral for Health Care Workers
tionally as a consequence of the coro- United States reported “considerably health condition, including symp- Gertie Quitangon, MD
navirus disease 2019 (COVID-19) elevated adverse mental health con- toms of anxiety disorder or depres-
sive disorder, trauma-related symp- NEUROPSYCHIATRY
toms, new or increased substance Easy to Miss, Hard to Treat
Rajesh R. Tampi, MD, MS, DFAPA, DFAAGP,
use, or thoughts of suicide (Figure). Deena J. Tampi, MSN, MBA-HCA, RN,
The prevalence of anxiety and depres- DFAAGP, and Michael Parish, MD
sion symptoms were substantially
higher than reported in 2019, and MOOD DISORDERS
people with preexisting (clinically The Role of Oxcarbazepine
diagnosed) psychiatric disorders re- David N. Osser, MD
ported an even higher prevalence of
symptoms, compared with those
CONTINUED ON PAGE 21 COMPLETE CONTENTS, PAGE 9
VISIT US
ONLINE PsychiatricTimes.com
NOW APPROVED
SPRAVATO®, IN CONJUNCTION WITH AN ORAL
ANTIDEPRESSANT, IS NOW APPROVED FOR
THE TREATMENT OF DEPRESSIVE SYMPTOMS
IN ADULTS WITH MDD WITH ACUTE SUICIDAL
IDEATION OR BEHAVIOR (MDSI)1
Limitations of Use:
• The effectiveness of SPRAVATO® in preventing
suicide or in reducing suicidal ideation or
behavior has not been demonstrated. Use of
SPRAVATO® does not preclude the need for
hospitalization if clinically warranted, even if
patients experience improvement after an
initial dose of SPRAVATO®.1
• SPRAVATO® is not approved as an anesthetic

agent. The safety and effectiveness of
SPRAVATO® as an anesthetic agent have not
been established.1
The most common adverse reactions with
SPRAVATO® plus oral antidepressant (incidence
≥5% and at least twice that of placebo
nasal spray plus oral antidepressant) were:
dissociation, dizziness, sedation, blood pressure
increased, hypoesthesia, vomiting, euphoric
mood, and vertigo.1
Learn more at www.spravatohcp.com
MDD=major depressive disorder. Important Safety Information

Reference: 1. SPRAVATO® [Prescribing Information]. Titusville, NJ: Janssen
Pharmaceuticals, Inc. July 2020.
WARNING: SEDATION, DISSOCIATION; ABUSE AND
MISUSE; and SUICIDAL THOUGHTS AND BEHAVIORS
Indications: See full prescribing information for complete boxed warning
SPRAVATO® (esketamine) CIII Nasal Spray is indicated, in • Risk for sedation and dissociation after administration.
conjunction with an oral antidepressant, for the treatment of: Monitor patients for at least two hours after
• Treatment-resistant depression (TRD) in adults. administration (5.1, 5.2).
• Depressive symptoms in adults with major depressive disorder • Potential for abuse and misuse. Consider the risks and
(MDD) with acute suicidal ideation or behavior. benefits of using SPRAVATO® prior to use in patients at
higher risk of abuse. Monitor for signs and symptoms of
Limitations of Use: abuse and misuse (5.3).
• The effectiveness of SPRAVATO® in preventing suicide • SPRAVATO® is only available through a restricted
or in reducing suicidal ideation or behavior has not been program called the SPRAVATO® REMS (5.4).
demonstrated. Use of SPRAVATO® does not preclude the
need for hospitalization if clinically warranted, even if patients • Increased risk of suicidal thoughts and behaviors
experience improvement after an initial dose of SPRAVATO®. in pediatric and young adult patients taking
antidepressants. Closely monitor all antidepressant-
• SPRAVATO® is not approved as an anesthetic agent. The safety treated patients for clinical worsening and emergence
and effectiveness of SPRAVATO® as an anesthetic agent have of suicidal thoughts and behaviors. SPRAVATO® is not
not been established. approved for use in pediatric patients (5.5).
Please see additional Important Safety Information and Brief Summary of full Prescribing Information, including Boxed WARNINGS,
on following pages. © Janssen Pharmaceuticals, Inc. 2020. September 2020 cp-178407v1
PSY1020_CV2-006_Spravato.indd 222 9/30/20 9:18 AM

Important Safety Information (continued)
CONTRAINDICATIONS Further information, including a list of certified pharmacies, is
SPRAVATO® is contraindicated in patients with: available at www.SPRAVATOrems.com or 1-855-382-6022.
• Aneurysmal vascular disease (including thoracic and
Suicidal Thoughts and Behaviors in Adolescents and Young
abdominal aorta, intracranial and peripheral arterial vessels)
Adults: In pooled analyses of placebo-controlled trials of
or arteriovenous malformation.
antidepressant drugs (SSRIs and other antidepressant classes)
• History of intracerebral hemorrhage.
that included adult and pediatric patients, the incidence of
• Hypersensitivity to esketamine, ketamine, or any of the
suicidal thoughts and behaviors in patients age 24 years and
excipients.
younger was greater than in placebo-treated patients. SPRAVATO®
WARNINGS AND PRECAUTIONS is not approved in pediatric (<18 years of age) patients.
Sedation: In clinical trials, 48% to 61% of SPRAVATO®-treated There was considerable variation in risk of suicidal thoughts and
patients developed sedation and 0.3% to 0.4% of SPRAVATO®- behaviors among drugs, but there was an increased risk identified
treated patients experienced loss of consciousness. in young patients for most drugs studied.
Because of the possibility of delayed or prolonged sedation, Monitor all antidepressant-treated patients for clinical worsening
patients must be monitored by a healthcare provider for at least and emergence of suicidal thoughts and behaviors, especially
2 hours at each treatment session, followed by an assessment to during the initial few months of drug therapy and at times
determine when the patient is considered clinically stable and of dosage changes. Counsel family members or caregivers
ready to leave the healthcare setting. of patients to monitor for changes in behavior and to alert
Closely monitor for sedation with concomitant use of SPRAVATO® the healthcare provider. Consider changing the therapeutic
with CNS depressants [see Drug Interaction (7.1)]. regimen, including possibly discontinuing SPRAVATO® and/or the
SPRAVATO® is available only through a restricted program under concomitant oral antidepressant, in patients whose depression
a REMS. is persistently worse, or who are experiencing emergent suicidal
Dissociation: The most common psychological effects of thoughts or behaviors.
SPRAVATO® were dissociative or perceptual changes (including Increase in Blood Pressure: SPRAVATO® causes increases in
distortion of time, space and illusions), derealization and systolic and/or diastolic blood pressure (BP) at all recommended
depersonalization (61% to 84% of SPRAVATO®-treated patients doses. Increases in BP peak approximately 40 minutes after
developed dissociative or perceptual changes). Given its SPRAVATO® administration and last approximately 4 hours.
potential to induce dissociative effects, carefully assess patients Approximately 8% to 19% of SPRAVATO®-treated patients
with psychosis before administering SPRAVATO®; treatment experienced an increase of more than 40 mmHg in systolic
should be initiated only if the benefit outweighs the risk. BP and/or 25 mmHg in diastolic BP in the first 1.5 hours after
Because of the risks of dissociation, patients must be monitored administration at least once during the first 4 weeks of treatment.
by a healthcare provider for at least 2 hours at each treatment A substantial increase in blood pressure could occur after
session, followed by an assessment to determine when the any dose administered even if smaller blood pressure effects
patient is considered clinically stable and ready to leave the were observed with previous administrations. SPRAVATO®
healthcare setting. is contraindicated in patients for whom an increase in BP or
SPRAVATO® is available only through a restricted program under intracranial pressure poses a serious risk (e.g., aneurysmal
a REMS. vascular disease, arteriovenous malformation, history of
Abuse and Misuse: SPRAVATO® contains esketamine, a Schedule intracerebral hemorrhage). Before prescribing SPRAVATO®,
III controlled substance (CIII), and may be subject to abuse and patients with other cardiovascular and cerebrovascular
diversion. Assess each patient’s risk for abuse or misuse prior conditions should be carefully assessed to determine whether the
to prescribing and monitor all patients for the development potential benefits of SPRAVATO® outweigh its risk.
of these behaviors or conditions, including drug-seeking Assess BP prior to administration of SPRAVATO®. In patients
behavior, while on therapy. Individuals with a history of drug whose BP is elevated prior to SPRAVATO® administration (as a
abuse or dependence are at greater risk; therefore, use careful general guide: >140/90 mmHg), a decision to delay SPRAVATO®
consideration prior to treatment of individuals with a history therapy should take into account the balance of benefit and risk
of substance use disorder and monitor for signs of abuse or in individual patients.
dependence. BP should be monitored for at least 2 hours after SPRAVATO®
SPRAVATO® is available only through a restricted program under administration. Measure blood pressure around 40 minutes
a REMS. post-dose and subsequently as clinically warranted until values
SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS): decline. If BP remains high, promptly seek assistance from
SPRAVATO® is available only through a restricted program called practitioners experienced in BP management. Refer patients
the SPRAVATO® REMS because of the risks of serious adverse experiencing symptoms of a hypertensive crisis (e.g., chest
outcomes from sedation, dissociation, and abuse and misuse. pain, shortness of breath) or hypertensive encephalopathy
Important requirements of the SPRAVATO® REMS include the (e.g., sudden severe headache, visual disturbances, seizures,
following: diminished consciousness, or focal neurological deficits)
• Healthcare settings must be certified in the program and immediately for emergency care.
ensure that SPRAVATO® is: Closely monitor blood pressure with concomitant use of
• Only dispensed and administered in healthcare settings. SPRAVATO® with psychostimulants or monoamine oxidase
• Patients treated in outpatient settings (e.g., medical offices inhibitors (MAOIs) [see Drug Interactions (7.2, 7.3)].
and clinics) must be enrolled in the program. In patients with history of hypertensive encephalopathy, more
• Administered by patients under the direct observation of intensive monitoring, including more frequent blood pressure
a healthcare provider and that patients are monitored by a and symptom assessment, is warranted because these patients
healthcare provider for at least 2 hours after administration of are at increased risk for developing encephalopathy with even
SPRAVATO®. small increases in blood pressure.
• Pharmacies must be certified in the REMS and must only
dispense SPRAVATO® to healthcare settings that are certified in Please see additional Important Safety Information and Brief
the program. Summary of full Prescribing Information, including Boxed
WARNINGS, on following pages.

Important Safety Information (continued)
Cognitive Impairment Lactation: SPRAVATO® is present in human milk. Because of the
Short-Term Cognitive Impairment: In a study in healthy potential for neurotoxicity, advise patients that breastfeeding is
volunteers, a single dose of SPRAVATO® caused cognitive not recommended during treatment with SPRAVATO®.
performance decline 40 minutes post-dose. SPRAVATO®-treated Females and Males of Reproductive Potential: SPRAVATO®
subjects required a greater effort to complete the cognitive tests may cause embryo-fetal harm when administered to a pregnant
at 40 minutes post-dose. Cognitive performance and mental woman. Consider pregnancy planning and prevention for females
effort were comparable between SPRAVATO® and placebo at of reproductive potential during treatment with SPRAVATO®.
2 hours post-dose. Sleepiness was comparable after 4 hours Pediatric Use: The safety and effectiveness of SPRAVATO® in
post-dose. pediatric patients have not been established.
Long-Term Cognitive Impairment: Long-term cognitive and Geriatric Use: Of the total number of patients in Phase 3 clinical
memory impairment have been reported with repeated ketamine studies exposed to SPRAVATO®, 12% were 65 years of age
misuse or abuse. No adverse effects of SPRAVATO® nasal spray and older, and 2% were 75 years of age and older. No overall
on cognitive functioning were observed in a one-year open- differences in the safety profile were observed between patients
label safety study; however, the long-term cognitive effects of 65 years of age and older and patients younger than 65 years of age.
SPRAVATO® have not been evaluated beyond one year. The mean esketamine Cmax and AUC values were higher in
Impaired Ability to Drive and Operate Machinery: Before elderly patients compared with younger adult patients.
SPRAVATO® administration, instruct patients not to engage in The efficacy of SPRAVATO® for the treatment of TRD in geriatric
potentially hazardous activities requiring complete mental patients was evaluated in a 4-week, randomized, double-blind
alertness and motor coordination, such as driving a motor study comparing flexibly-dosed intranasal SPRAVATO® plus
vehicle or operating machinery, until the next day following a a newly initiated oral antidepressant compared to intranasal
restful sleep. Patients will need to arrange transportation home placebo plus a newly initiated oral antidepressant in patients
following treatment with SPRAVATO®. ≥65 years of age. At the end of four weeks, there was no
Ulcerative or Interstitial Cystitis: Cases of ulcerative or statistically significant difference between groups on the primary
interstitial cystitis have been reported in individuals with long- efficacy endpoint of change from baseline to Week 4 on the
term off-label use or misuse/abuse of ketamine. In clinical Montgomery-Åsberg Depression Rating Scale (MADRS).
studies with SPRAVATO® nasal spray, there was a higher rate of Hepatic Impairment: SPRAVATO®-treated patients with moderate
lower urinary tract symptoms (pollakiuria, dysuria, micturition hepatic impairment may need to be monitored for adverse
urgency, nocturia, and cystitis) in SPRAVATO®-treated patients reactions for a longer period of time.
than in placebo-treated patients. No cases of esketamine-related SPRAVATO® has not been studied in patients with severe hepatic
interstitial cystitis were observed in any of the studies, which impairment (Child-Pugh class C). Use in this population is not
involved treatment for up to a year. recommended.
Monitor for urinary tract and bladder symptoms during the
DRUG ABUSE AND DEPENDENCE
course of treatment with SPRAVATO® and refer to an appropriate
Controlled Substance: SPRAVATO® contains esketamine
healthcare provider as clinically warranted.
hydrochloride, the (S)-enantiomer of ketamine and a Schedule III
Embryo-fetal Toxicity: SPRAVATO® may cause fetal harm when
controlled substance under the Controlled Substances Act.
administered to pregnant women. Advise pregnant women of the
Abuse: Individuals with a history of drug abuse or dependence
potential risk to an infant exposed to SPRAVATO® in utero. Advise women
may be at greater risk for abuse and misuse of SPRAVATO®. Abuse
of reproductive potential to consider pregnancy planning and prevention.
is the intentional, non-therapeutic use of a drug, even once, for
DRUG INTERACTIONS its psychological or physiological effects. Misuse is the intentional
CNS depressants (e.g., benzodiazepines, opioids, alcohol): use, for therapeutic purposes, of a drug by an individual in a way
Concomitant use may increase sedation. Closely monitor for other than prescribed by a healthcare provider or for whom it
sedation with concomitant use of CNS depressants. was not prescribed. Careful consideration is advised prior to use
Psychostimulants (e.g., amphetamines, methylphenidate, of individuals with a history of substance use disorder, including
modafinil, armodafinil): Concomitant use may increase blood alcohol.
pressure. Closely monitor blood pressure with concomitant use of SPRAVATO® may produce a variety of symptoms including anxiety,
psychostimulants. dysphoria, disorientation, insomnia, flashback, hallucinations,
Monoamine oxidase inhibitors (MAOIs): Concomitant use may and feelings of floating, detachment, and to be “spaced out.”
increase blood pressure. Closely monitor blood pressure with Monitoring for signs of abuse and misuse is recommended.
concomitant use of MAOIs.
ADVERSE REACTIONS
USE IN SPECIFIC POPULATIONS The most common adverse reactions with SPRAVATO® plus oral
Pregnancy: SPRAVATO® is not recommended during pregnancy. antidepressant (incidence ≥5% and at least twice that of placebo
SPRAVATO® may cause fetal harm when administered to pregnant nasal spray plus oral antidepressant) were:
women. Advise pregnant women of the potential risk to an infant TRD: dissociation, dizziness, nausea, sedation, vertigo,
exposed to SPRAVATO® in utero. There are risks to the mother hypoesthesia, anxiety, lethargy, blood pressure increased,
associated with untreated depression in pregnancy. If a woman vomiting, and feeling drunk.
becomes pregnant while being treated with SPRAVATO®, treatment Treatment of depressive symptoms in adults with MDD with acute
with SPRAVATO® should be discontinued and the patient should be suicidal ideation or behavior: dissociation, dizziness, sedation,
counseled about the potential risk to the fetus. blood pressure increased, hypoesthesia, vomiting, euphoric
Pregnancy Exposure Registry: There is a pregnancy exposure registry mood, and vertigo.
that monitors pregnancy outcomes in women exposed to
Please see additional Important Safety Information and Brief
antidepressants, including SPRAVATO®, during pregnancy.
Summary of full Prescribing Information, including Boxed
Healthcare providers are encouraged to register patients by
WARNINGS, on following pages.
contacting the National Pregnancy Registry for Antidepressants at
1-844-405-6185 or online at https://womensmentalhealth.org/ cp-170362v1
clinical-and-research-programs/pregnancyregistry/antidepressants/.
© Janssen Pharmaceuticals, Inc. 2020. September 2020 cp-178407v1

SPRAVATO® SPRAVATO® (esketamine) nasal spray, CIII
(esketamine) nasal spray, CIII
Brief Summary Suicidal Thoughts and Behaviors in Adolescents and Young Adults
BEFORE PRESCRIBING SPRAVATO®, PLEASE SEE FULL PRESCRIBING INFORMATION, INCLUDING In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant
BOXED WARNING. classes) that included approximately 77,000 adult patients and 4,500 pediatric patients (SPRAVATO is
WARNING: SEDATION; DISSOCIATION; ABUSE AND MISUSE; and not approved in pediatric patients), the incidence of suicidal thoughts and behaviors in patients age
SUICIDAL THOUGHTS AND BEHAVIORS 24 years and younger was greater than in placebo-treated patients. There was considerable variation
in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in
Sedation young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts
• Patients are at risk for sedation after administration of SPRAVATO [see Warnings and Precautions]. and behaviors across the different indications, with the highest incidence in patients with major
Dissociation depressive disorder (MDD). The drug-placebo differences in the number of cases of suicidal thoughts
• Patients are at risk for dissociative or perceptual changes after administration of SPRAVATO [see and behaviors per 1000 patients treated are provided in Table 1.
Warnings and Precautions].
Because of the risks of sedation and dissociation, patients must be monitored for at least 2 hours Table 1: Risk Differences of the Number of Patients with Suicidal Thoughts or Behaviors in the
at each treatment session, followed by an assessment to determine when the patient is considered Pooled Placebo-Controlled Trials of Antidepressants in Pediatric* and Adult Patients
clinically stable and ready to leave the healthcare setting [see Warnings and Precautions]. Age Range (Years) Drug-Placebo Difference in Number of Patients with
Abuse and Misuse Suicidal Thoughts or Behaviors per 1000 Patients Treated
• SPRAVATO has the potential to be abused and misused. Consider the risks and benefits of Increases Compared to Placebo
prescribing SPRAVATO prior to use in patients at higher risk of abuse. Monitor patients for <18 14 additional patients
signs and symptoms of abuse and misuse [see Warnings and Precautions]. 18-24 5 additional patients
Because of the risks of serious adverse outcomes resulting from sedation, dissociation, and abuse Decreases Compared to Placebo
and misuse, SPRAVATO is only available through a restricted program under a Risk Evaluation and
Mitigation Strategy (REMS) called the SPRAVATO REMS [see Warnings and Precautions]. 25-64 1 fewer patient
Suicidal Thoughts and Behaviors ≥65 6 fewer patients
Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult * SPRAVATO is not approved in pediatric patients.
patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical
worsening, and for emergence of suicidal thoughts and behaviors. SPRAVATO is not approved for It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young
use in pediatric patients [see Warnings and Precautions]. adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence
from placebo-controlled maintenance studies in adults with MDD that antidepressants delay the
recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors.
INDICATIONS AND USAGE
Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts
SPRAVATO® is indicated, in conjunction with an oral antidepressant, for the treatment of:
and behaviors, especially during the initial few months of drug therapy and at times of dosage changes.
• Treatment-resistant depression (TRD) in adults Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the
• Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing
or behavior SPRAVATO and/or the concomitant oral antidepressant, in patients whose depression is persistently
Limitations of Use: worse, or who are experiencing emergent suicidal thoughts or behaviors.
• The effectiveness of SPRAVATO in preventing suicide or in reducing suicidal ideation or behavior Increase in Blood Pressure
has not been demonstrated [see Clinical Studies (14.2) in Full Prescribing Information]. Use of SPRAVATO causes increases in systolic and/or diastolic blood pressure (BP) at all recommended
SPRAVATO does not preclude the need for hospitalization if clinically warranted, even if patients doses. Increases in BP peak approximately 40 minutes after SPRAVATO administration and last
experience improvement after an initial dose of SPRAVATO. approximately 4 hours [see Adverse Reactions].
• SPRAVATO is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO as Approximately 8% to 19% of SPRAVATO-treated patients and 1% to 4% of placebo-treated patients
an anesthetic agent have not been established. experienced an increase of greater than or equal to 40 mmHg in systolic BP and/or 25 mmHg in diastolic
CONTRAINDICATIONS BP in the first 1.5 hours after administration at least once during the first 4 weeks of treatment. A
SPRAVATO is contraindicated in patients with: substantial increase in blood pressure could occur after any dose administered even if smaller blood
pressure effects were observed with previous administrations. SPRAVATO is contraindicated in patients
• Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial, and peripheral for whom an increase in BP or intracranial pressure poses a serious risk (e.g., aneurysmal vascular
arterial vessels) or arteriovenous malformation [see Warnings and Precautions] disease, arteriovenous malformation, history of intracerebral hemorrhage) [see Contraindications].
• History of intracerebral hemorrhage [see Warnings and Precautions] Before prescribing SPRAVATO, patients with other cardiovascular and cerebrovascular conditions
• Hypersensitivity to esketamine, ketamine, or any of the excipients. should be carefully assessed to determine whether the potential benefits of SPRAVATO outweigh its risks.
WARNINGS AND PRECAUTIONS Assess BP prior to administration of SPRAVATO. In patients whose BP is elevated prior to SPRAVATO
Sedation administration (as a general guide: >140/90 mmHg) a decision to delay SPRAVATO therapy should take
In clinical trials, 48% to 61% of SPRAVATO-treated patients developed sedation based on the Modified into account the balance of benefit and risk in individual patients.
Observer’s Assessment of Alertness/Sedation scale (MOAA/S) [see Adverse Reactions], and 0.3% to BP should be monitored for at least 2 hours after SPRAVATO administration [see Dosage and
0.4% of SPRAVATO-treated patients experienced loss of consciousness (MOAA/S score of 0). Administration (2.1, 2.4) in Full Prescribing Information]. Measure blood pressure around 40 minutes
Because of the possibility of delayed or prolonged sedation, patients must be monitored by a healthcare post-dose and subsequently as clinically warranted until values decline. If BP remains high, promptly
provider for at least 2 hours at each treatment session, followed by an assessment to determine when seek assistance from practitioners experienced in BP management. Refer patients experiencing
the patient is considered clinically stable and ready to leave the healthcare setting [see Dosage and symptoms of a hypertensive crisis (e.g., chest pain, shortness of breath) or hypertensive encephalopathy
Administration (2.4) in Full Prescribing Information]. (e.g., sudden severe headache, visual disturbances, seizures, diminished consciousness or focal
neurological deficits) immediately for emergency care.
Closely monitor for sedation with concomitant use of SPRAVATO with CNS depressants [see Drug
Interaction]. Closely monitor blood pressure with concomitant use of SPRAVATO with psychostimulants or
monoamine oxidase inhibitors (MAOIs) [see Drug Interactions].
SPRAVATO is available only through a restricted program under a REMS [see Warnings and Precautions].
In patients with history of hypertensive encephalopathy, more intensive monitoring, including more
Dissociation frequent blood pressure and symptom assessment, is warranted because these patients are at
The most common psychological effects of SPRAVATO were dissociative or perceptual changes (including increased risk for developing encephalopathy with even small increases in blood pressure.
distortion of time, space and illusions), derealization and depersonalization (61% to 84% of SPRAVATO- Cognitive Impairment
treated patients developed dissociative or perceptual changes based on the Clinician-Administered
Dissociative States Scale) [see Adverse Reactions]. Given its potential to induce dissociative effects, Short-Term Cognitive Impairment
carefully assess patients with psychosis before administering SPRAVATO; treatment should be initiated In a study in healthy volunteers, a single dose of SPRAVATO caused cognitive performance decline
only if the benefit outweighs the risk. 40 minutes post-dose. Compared to placebo-treated subjects, SPRAVATO-treated subjects required a
greater effort to complete cognitive tests at 40 minutes post-dose. Cognitive performance and mental
Because of the risks of dissociation, patients must be monitored by a healthcare provider for at least
effort were comparable between SPRAVATO and placebo at 2 hours post-dose. Sleepiness was
2 hours at each treatment session, followed by an assessment to determine when the patient is
comparable after 4 hours post-dose.
considered clinically stable and ready to leave the healthcare setting [see Dosage and Administration
(2.4) in Full Prescribing Information]. Long-Term Cognitive Impairment
SPRAVATO is available only through a restricted program under a REMS [see Warnings and Long-term cognitive and memory impairment have been reported with repeated ketamine misuse or
Precautions]. abuse. No adverse effects of SPRAVATO nasal spray on cognitive functioning were observed in a one-
year open-label safety study; however, the long-term cognitive effects of SPRAVATO have not been
Abuse and Misuse evaluated beyond one year.
SPRAVATO contains esketamine, a Schedule III controlled substance (CIII), and may be subject to
abuse and diversion. Assess each patient’s risk for abuse or misuse prior to prescribing SPRAVATO Impaired Ability to Drive and Operate Machinery
and monitor all patients receiving SPRAVATO for the development of these behaviors or conditions, Two placebo-controlled studies were conducted to assess the effects of SPRAVATO on the ability to
including drug-seeking behavior, while on therapy. Contact local state professional licensing board or drive [see Clinical Studies (14.3) in Full Prescribing Information]. The effects of SPRAVATO 84 mg were
state-controlled substances authority for information on how to prevent and detect abuse or diversion comparable to placebo at 6 hours and 18 hours post-dose. However, two SPRAVATO-treated subjects
of SPRAVATO. Individuals with a history of drug abuse or dependence are at greater risk; therefore, in one of the studies discontinued the driving test at 8 hours post-dose because of SPRAVATO-related
use careful consideration prior to treatment of individuals with a history of substance use disorder and adverse reactions.
monitor for signs of abuse or dependence [see Drug Abuse and Dependence]. Before SPRAVATO administration, instruct patients not to engage in potentially hazardous activities
SPRAVATO is available only through a restricted program under a REMS [see Warnings and Precautions]. requiring complete mental alertness and motor coordination, such as driving a motor vehicle or
operating machinery, until the next day following a restful sleep. Patients will need to arrange
SPRAVATO Risk Evaluation and Mitigation Strategy (REMS) transportation home following treatment with SPRAVATO.
SPRAVATO is available only through a restricted program under a REMS called the SPRAVATO REMS
because of the risks of serious adverse outcomes from sedation, dissociation, and abuse and misuse Ulcerative or Interstitial Cystitis
[see Boxed Warning and Warnings and Precautions]. Cases of ulcerative or interstitial cystitis have been reported in individuals with long-term off-label
use or misuse/abuse of ketamine. In clinical studies with SPRAVATO nasal spray, there was a higher
Important requirements of the SPRAVATO REMS include the following: rate of lower urinary tract symptoms (pollakiuria, dysuria, micturition urgency, nocturia, and cystitis)
• Healthcare settings must be certified in the program and ensure that SPRAVATO is: in SPRAVATO-treated patients than in placebo-treated patients [see Adverse Reactions]. No cases of
– Only dispensed and administered in healthcare settings. esketamine-related interstitial cystitis were observed in any of the studies, which included treatment
– Patients treated in outpatient settings (e.g. medical offices and clinics) must be enrolled in the program. for up to a year.
– Administered by patients under the direct observation of a healthcare provider and that patients Monitor for urinary tract and bladder symptoms during the course of treatment with SPRAVATO, and
are monitored by a healthcare provider for at least 2 hours after administration of SPRAVATO [see refer to an appropriate healthcare provider as clinically warranted.
Dosage and Administration (2.4) in Full Prescribing Information]. Embryo-fetal Toxicity
• Pharmacies must be certified in the REMS and must only dispense SPRAVATO to healthcare settings Based on published findings from pregnant animals treated with ketamine, the racemic mixture of
that are certified in the program. arketamine and esketamine, SPRAVATO may cause fetal harm when administered to pregnant women.
Further information, including a list of certified pharmacies is available at www.SPRAVATOrems.com Advise pregnant women of the potential risk to an infant exposed to SPRAVATO in utero. Advise women of
or 1-855-382-6022. reproductive potential to consider pregnancy planning and prevention [see Use in Specific Populations].

SPRAVATO® (esketamine) nasal spray, CIII SPRAVATO® (esketamine) nasal spray, CIII
ADVERSE REACTIONS Dizziness includes: dizziness; dizziness exertional; dizziness postural; procedural dizziness
The following adverse reactions are discussed in more detail in other sections of the labeling: Dysarthria includes: dysarthria; slow speech; speech disorder
• Sedation [see Warnings and Precautions] Dysgeusia includes: dysgeusia; hypogeusia
Headache includes: headache; sinus headache
• Dissociation [see Warnings and Precautions]
Hypoesthesia includes: hypoesthesia; hypoesthesia oral, hypoesthesia teeth, pharyngeal hypoesthesia
• Increase in Blood Pressure [see Warnings and Precautions] Lethargy includes: fatigue; lethargy
• Cognitive Impairment [see Warnings and Precautions] Nasal discomfort includes: nasal crusting; nasal discomfort; nasal dryness; nasal pruritus
• Impaired Ability to Drive and Operate Machinery [see Warnings and Precautions] Sedation includes: altered state of consciousness; hypersomnia; sedation; somnolence
• Ulcerative or Interstitial Cystitis [see Warnings and Precautions] Tachycardia includes: extrasystoles; heart rate increased; tachycardia
• Embryo-fetal Toxicity [see Warnings and Precautions] Vertigo includes: vertigo; vertigo positional
Clinical Trials Experience Depressive Symptoms in Patients with Major Depressive Disorder with Acute Suicidal Ideation or Behavior
Because clinical trials are conducted under widely varying conditions, adverse reaction rates SPRAVATO was evaluated for safety in 262 adults for the treatment of depressive symptoms in adults
observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of with major depressive disorder (MDD) with acute suicidal ideation or behavior [see Clinical Studies
another drug and may not reflect the rates observed in clinical practice. (14.2) in Full Prescribing Information] from two Phase 3 studies (Study 3 and Study 4) and one Phase 2
Treatment-Resistant Depression study. Of all SPRAVATO-treated patients in the completed Phase 3 studies, 184 (81%) received all eight
doses over a 4-week treatment period.
SPRAVATO was evaluated for safety in 1709 adults diagnosed with treatment-resistant depression
(TRD) [see Clinical Studies (14.1) in Full Prescribing Information] from five Phase 3 studies (3 short-term Adverse Reactions Leading to Discontinuation of Treatment
and 2 long-term studies) and one Phase 2 dose-ranging study. Of all SPRAVATO-treated patients in the In short-term studies in adults (pooled Study 3 and Study 4), the proportion of patients who discontinued
completed Phase 3 studies, 479 (30%) received at least 6 months of treatment, and 178 (11%) received treatment because of an adverse reaction was 6.2% for patients who received SPRAVATO plus oral
at least 12 months of treatment. AD compared to 3.6% for patients who received placebo nasal spray plus oral AD. Adverse reactions
Adverse Reactions Leading to Discontinuation of Treatment leading to SPRAVATO discontinuation in more than 1 patient were (in order of frequency): dissociation-
related events (2.6%), blood pressure increased (0.9%), dizziness-related events (0.9%), nausea (0.9%),
In short-term studies in adults < 65 years old (Study 1 pooled with another 4-week study), the proportion
and sedation-related events (0.9%).
of patients who discontinued treatment because of an adverse reaction was 4.6% in patients who
received SPRAVATO plus oral AD compared to 1.4% for patients who received placebo nasal spray Most Common Adverse Reactions
plus oral AD. For adults ≥ 65 years old, the proportions were 5.6% and 3.1%, respectively. In Study The most commonly observed adverse reactions in patients treated with SPRAVATO plus oral AD
2, a long-term maintenance study, the discontinuation rates because of an adverse reaction were (incidence ≥5% and at least twice that of placebo nasal spray plus oral AD) were dissociation, dizziness,
similar for patients receiving SPRAVATO plus oral AD and placebo nasal spray plus oral AD in the sedation, blood pressure increased, hypoesthesia, vomiting, euphoric mood, and vertigo. Table 3 shows
maintenance phase, at 2.6% and 2.1%, respectively. Across all Phase 3 studies, adverse reactions the incidence of adverse reactions that occurred in patients treated with SPRAVATO plus oral AD and
leading to SPRAVATO discontinuation in more than 2 patients were (in order of frequency): anxiety greater than patients treated with placebo nasal spray plus oral AD.
(1.2%), depression (0.9%), blood pressure increased (0.6%), dizziness (0.6%), suicidal ideation (0.5%),
dissociation (0.4%), nausea (0.4%), vomiting (0.4%), headache (0.3%), muscular weakness (0.3%), Table 3: Adverse Reactions Occurring in ≥2% of Adult Patients with MDD and Acute Suicidal Ideation or
vertigo (0.2%), hypertension (0.2%), panic attack (0.2%) and sedation (0.2%). Behavior Treated with SPRAVATO + Oral AD and at a Greater Rate than Patients Treated with
Placebo Nasal Spray + Oral AD
Most Common Adverse Reactions
SPRAVATO + Oral AD Placebo + Oral AD
The most commonly observed adverse reactions in patients treated with SPRAVATO plus oral AD
(incidence ≥5% and at least twice that of placebo nasal spray plus oral AD) were dissociation, dizziness, (N=227) (N=225)
nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, blood pressure increased, vomiting, and Cardiac disorders
feeling drunk. Tachycardia* 8 (4%) 2 (1%)
Table 2 shows the incidence of adverse reactions that occurred in patients treated with SPRAVATO Ear and labyrinth disorders
plus oral AD at any dose and greater than patients treated with placebo nasal spray plus oral AD. Vertigo 14 (6%) 1 (0.4%)
Table 2: Adverse Reactions Occurring in ≥2% of Adult TRD Patients Treated with SPRAVATO + Oral AD Gastrointestinal disorders
at Any Dose and at a Greater Rate than Patients Treated with Placebo Nasal Spray + Oral AD Nausea 61 (27%) 31 (14%)
SPRAVATO + Oral AD Placebo + Oral AD Vomiting 26 (11%) 12 (5%)
(N=346) (N=222)
Constipation 22 (10%) 14 (6%)
Cardiac disorders
Dry mouth 8 (4%) 6 (3%)
Tachycardia* 6 (2%) 1 (0.5%)
Toothache 5 (2%) 2 (1%)
Ear and labyrinth disorders
General disorders and administration site conditions
Vertigo* 78 (23%) 6 (3%)
Feeling drunk 8 (4%) 1 (0.4%)
Gastrointestinal disorders
Feeling of relaxation 5 (2%) 3 (1%)
Nausea 98 (28%) 19 (9%)
Vomiting 32 (9%) 4 (2%) Investigations
Diarrhea 23 (7%) 13 (6%) Blood pressure increased* 34 (15%) 14 (6%)
Dry mouth 19 (5%) 7 (3%) Musculoskeletal and connective tissue disorders
Constipation 11 (3%) 3 (1%) Myalgia 5 (2%) 1 (0.4%)
General disorders and administration site conditions Nervous system disorders
Feeling drunk 19 (5%) 1 (0.5%) Dizziness* 103 (45%) 34 (15%)
Feeling abnormal 12 (3%) 0 (0%) Sedation* 66 (29%) 27 (12%)
Investigations Dysgeusia* 46 (20%) 29 (13%)
Blood pressure increased* 36 (10%) 6 (3%) Hypoesthesia* 30 (13%) 4 (2%)
Nervous system disorders Lethargy* 10 (4%) 4 (2%)
Dizziness* 101 (29%) 17 (8%) Confusional state 5 (2%) 0 (0%)
Sedation* 79 (23%) 21 (9%) Psychiatric disorders
Headache* 70 (20%) 38 (17%) Dissociation* 108 (48%) 30 (13%)
Dysgeusia* 66 (19%) 30 (14%) Anxiety* 34 (15%) 20 (9%)
Hypoesthesia* 63 (18%) 5 (2%) Euphoric mood 17 (7%) 1 (0.4%)
Lethargy* 37 (11%) 12 (5%) Intentional self-injury 7 (3%) 3 (1%)
Dysarthria* 15 (4%) 0 (0%)
Dysphoria 5 (2%) 0 (0%)
Tremor 12 (3%) 2 (1%)
Renal and urinary disorders
Mental impairment 11 (3%) 2 (1%)
Pollakiuria* 5 (2%) 2 (1%)
Psychiatric disorders
Respiratory, thoracic and mediastinal disorders
Dissociation* 142 (41%) 21 (9%)
Anxiety* 45 (13%) 14 (6%) Oropharyngeal pain 10 (4%) 3 (1%)
Insomnia 29 (8%) 16 (7%) Throat irritation 9 (4%) 5 (2%)
Euphoric mood 15 (4%) 2 (1%) Skin and subcutaneous tissue disorders
Renal and urinary disorders Hyperhidrosis* 11 (5%) 5 (2%)
Pollakiuria 11 (3%) 1 (0.5%) * The following terms were combined:
Respiratory, thoracic and mediastinal disorders Anxiety includes: agitation; anxiety; anxiety disorder; fear; irritability; nervousness; panic attack;
Nasal discomfort* 23 (7%) 11 (5%) psychomotor hyperactivity; tension
Blood pressure increased includes: blood pressure diastolic increased; blood pressure increased;
Throat irritation 23 (7%) 9 (4%) blood pressure systolic increased; hypertension
Oropharyngeal pain 9 (3%) 5 (2%) Dissociation includes: depersonalization/derealization disorder; derealization; diplopia; dissociation;
Skin and subcutaneous tissue disorders dysesthesia; feeling cold; feeling hot; hallucination; hallucination, auditory; hallucination, visual;
Hyperhidrosis 14 (4%) 5 (2%) hallucinations, mixed; hyperacusis; paresthesia; paresthesia oral; pharyngeal paresthesia;
photophobia; time perception altered; tinnitus; vision blurred
* The following terms were combined: Dizziness includes: dizziness; dizziness exertional; dizziness postural
Anxiety includes: agitation; anticipatory anxiety; anxiety; fear; feeling jittery; irritability; nervousness; Dysgeusia includes: dysgeusia; hypogeusia
panic attack; tension Hyperhidrosis includes: cold sweat; hyperhidrosis
Blood pressure increased includes: blood pressure diastolic increased; blood pressure increased; Hypoesthesia includes: hypoesthesia; hypoesthesia oral; intranasal hypoesthesia; pharyngeal
blood pressure systolic increased; hypertension hypoesthesia
Dissociation includes: delusional perception; depersonalization/derealization disorder; derealization; Lethargy includes: fatigue; lethargy; psychomotor retardation
diplopia; dissociation; dysesthesia; feeling cold; feeling hot; feeling of body temperature change; Pollakiuria includes: micturition urgency; pollakiuria
hallucination; hallucination, auditory; hallucination, visual; hyperacusis; illusion; ocular discomfort; oral Sedation includes: sedation; somnolence; stupor
dysesthesia; paresthesia; paresthesia oral; pharyngeal paresthesia; photophobia; time perception altered; Tachycardia includes: heart rate increased; sinus tachycardia; tachycardia
tinnitus; vision blurred; visual impairment

SPRAVATO® (esketamine) nasal spray, CIII SPRAVATO® (esketamine) nasal spray, CIII
Sedation Sense of Smell

Sedation was evaluated by adverse event reports and the Modified Observer’s Assessment of Sense of smell was assessed over time; no difference was observed between patients treated with
Alertness/Sedation (MOAA/S). In the MOAA/S, 5 means “responds readily to name spoken in normal SPRAVATO plus oral AD and those treated with placebo nasal spray plus oral AD during the double-
tone” and 0 means “no response after painful trapezius squeeze.” Any decrease in MOAA/S from blind maintenance phase of Study 2 [see Clinical Studies (14.1) in Full Prescribing Information].
pre-dose is considered to indicate the presence of sedation, and such a decrease occurred in a higher DRUG INTERACTIONS
number of patients on SPRAVATO than placebo during the short-term TRD studies. Dose-related
increases in the incidence of sedation (MOAA/S score <5) were observed in a fixed-dose TRD study Central Nervous System Depressants
[see Warnings and Precautions]. Table 4 presents the incidence of sedation (MOAA/S score <5) in a Concomitant use with CNS depressants (e.g., benzodiazepines, opioids, alcohol) may increase sedation
fixed-dose study with adult patients <65 years of age with TRD and a flexible-dose study with patients [see Warnings and Precautions]. Closely monitor for sedation with concomitant use of SPRAVATO with
≥65 years of age with TRD. CNS depressants.
Psychostimulants
Table 4: Incidence of Sedation (MOAA/S Score <5) in Double-Blind, Randomized, Placebo-Controlled
Concomitant use with psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil)
Studies (Fixed-Dose Study with Adult Patients <65 Years of Age with TRD and Flexible-Dose may increase blood pressure [see Warnings and Precautions]. Closely monitor blood pressure with
Study with Patients ≥65 Years of Age with TRD) concomitant use of SPRAVATO with psychostimulants.
Patients <65 years Patients ≥65 years
Monoamine Oxidase Inhibitors (MAOIs)
Placebo + SPRAVATO + Placebo + SPRAVATO + Concomitant use with monoamine oxidase inhibitors (MAOIs) may increase blood pressure [see Warnings
Oral AD Oral AD Oral AD Oral AD and Precautions]. Closely monitor blood pressure with concomitant use of SPRAVATO with MAOIs.
56 mg 84 mg 28 to 84 mg USE IN SPECIFIC POPULATIONS
Number of patients* N=112 N=114 N=114 N=63 N=72 Pregnancy
Sedation (MOAA/S score <5) 11% 50% 61% 19% 49% Pregnancy Exposure Registry
*Patients who were evaluated with MOAA/S There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to
In studies for the treatment of depressive symptoms in adults with MDD with acute suicidal ideation antidepressants, including SPRAVATO, during pregnancy. Healthcare providers are encouraged to register
or behavior, there was a higher incidence of sedation (MOAA/S score <5) in patients treated with patients by contacting the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at
SPRAVATO plus oral AD compared to patients treated with placebo plus oral AD, similar to the TRD https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
study results in Table 4. Risk Summary
Dissociation/Perceptual Changes SPRAVATO is not recommended during pregnancy. There are insufficient data on SPRAVATO use in pregnant
SPRAVATO can cause dissociative symptoms (including derealization and depersonalization) and women to draw conclusions about any drug-associated risk of major birth defects, miscarriage, or adverse
perceptual changes (including distortion of time and space, and illusions). In clinical trials, dissociation maternal or fetal outcomes. Based on published findings from pregnant animals treated with ketamine, the
was transient and occurred on the day of dosing. Dissociation was evaluated by adverse event reports racemic mixture of arketamine and esketamine, SPRAVATO may cause fetal harm when administered to
and the Clinician-Administered Dissociative States Scale (CADSS). A CADSS total score of more than 4 pregnant women (see Data). Advise pregnant women of the potential risk to an infant exposed to SPRAVATO
indicates the presence of dissociative symptoms, and such an increase to a score of 4 or more occurred in utero. There are risks to the mother associated with untreated depression in pregnancy (see Clinical
in a higher number of patients on SPRAVATO compared to placebo during the short-term TRD studies. Considerations). If a woman becomes pregnant while being treated with SPRAVATO, treatment with
Dose-related increases in the incidence of dissociative symptoms (CADSS total score >4 and change >0) esketamine should be discontinued and the patient should be counseled about the potential risk to the fetus.
were observed in a fixed-dose TRD study [see Warnings and Precautions]. Table 5 presents the incidence Published studies in pregnant primates demonstrate that the administration of drugs that block
of dissociation (CADSS total score >4 and change >0) in a fixed-dose study with adult patients <65 years N-methyl-D-aspartate (NMDA) receptors during the period of peak brain development increases
of age with TRD and a flexible-dose study with patients ≥65 years of age with TRD. neuronal apoptosis in the developing brain of the offspring. There are no data on pregnancy exposures
Table 5: Incidence of Dissociation (CADSS Total Score >4 and Change >0) in Double-Blind, in primates corresponding to periods prior to the third trimester in humans [see Use in Specific
Populations].
Randomized, Placebo-Controlled Studies (Fixed-Dose Study with Adult Patients <65 Years
of Age with TRD and Flexible-Dose Study with Patients ≥65 Years of Age with TRD) In an embryo-fetal reproduction study in rabbits, skeletal malformations were noted at maternally
toxic doses when ketamine was intranasally administered with a No Observed Adverse Effect Level
Patients <65 years Patients ≥65 years (NOAEL) at estimated esketamine exposures 0.3 times the exposures at the maximum recommended
SPRAVATO SPRAVATO human dose (MRHD) of 84 mg/day. In addition, intranasal administration of esketamine to pregnant rats
Placebo + + Oral AD Placebo + + Oral AD
Oral AD Oral AD during pregnancy and lactation at exposures that were similar to those at the MRHD resulted in a delay
56 mg 84 mg 28 to 84 mg in sensorimotor development in pups during the preweaning period and a decrease in motor activity
Number of patients* N=113 N=113 N=116 N=65 N=72 in the post-weaning period.
CADSS total score >4 and The estimated background risk of major birth defects and miscarriage for the indicated population is
change >0 5% 61% 69% 12% 75% unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In
the U.S. general population, the estimated background risk of major birth defects and miscarriage in
* Number of patients who were evaluated with CADSS clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
In studies for the treatment of depressive symptoms in adults with MDD with acute suicidal ideation Clinical Considerations
or behavior, patients treated with SPRAVATO plus oral AD also demonstrated a higher number (84%) Disease-Associated Maternal and/or Embryo-Fetal Risk
with dissociation (CADSS total score >4 and change >0) compared to patients treated with placebo
plus oral AD (16%). A prospective, longitudinal study followed 201 pregnant women with a history of major depressive
disorder who were euthymic and taking antidepressants at the beginning of pregnancy. The women
Increase in Blood Pressure who discontinued antidepressants during pregnancy were more likely to experience a relapse of major
The mean placebo-adjusted increases in systolic and diastolic blood pressure (SBP and DBP) over depression than women who continued antidepressants. Consider the risk of untreated depression when
time were about 7 to 9 mmHg in SBP and 4 to 6 mmHg in DBP at 40 minutes post-dose and 2 to 5 mmHg discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.
in SBP and 1 to 3 mmHg in DBP at 1.5 hours post-dose in patients with TRD receiving SPRAVATO plus
oral antidepressants [see Warnings and Precautions]. Table 6 presents increases in blood pressure in Data
short-term trials with patients <65 years of age and ≥65 years of age with TRD. Animal Data
Based on published data, when female monkeys were treated intravenously with racemic ketamine
Table 6: Increases in Blood Pressure in Double-blind, Randomized, Placebo-Controlled, Short-Term at anesthetic dose levels in the third trimester of pregnancy, neuronal cell death was observed in the
Trials of SPRAVATO + Oral AD Compared to Placebo Nasal Spray + Oral AD in the Treatment brains of their fetuses. This period of brain development translates into the third trimester of human
of TRD in Adult Patients pregnancy. The clinical significance of these findings is not clear; however, studies in juvenile animals
Patients <65 years Patients ≥65 years suggest neuroapoptosis correlates with long-term cognitive deficits.
SPRAVATO Placebo + SPRAVATO Placebo + Racemic ketamine was administered intranasally to pregnant rats during the period of organogenesis
+ Oral AD Oral AD + Oral AD Oral AD at doses of 15, 50, and 150 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for embryo-
N=346 N=222 N=72 N=65 fetal toxicity in rats was the highest dose of 150 mg/kg/day. Estimating 50% of the exposure to be
Systolic blood pressure from esketamine, the NOAEL associated with esketamine plasma exposure (AUC) is 12-times the
AUC exposure at the MRHD of 84 mg/day. In pregnant rabbits, racemic ketamine was administered
≥180 mmHg 9 (3%) --- 2 (3%) 1 (2%) intranasally from gestational day 6 to 18 at doses of 10, 30, and 100 mg/kg/day. The high dose was
≥40 mmHg increase 29 (8%) 1 (0.5%) 12 (17%) 1 (2%) lowered from 100 to 50 mg/kg after 5 days of dosing due to excessive mortality in the pregnant rabbits.
Diastolic blood pressure Skeletal malformations were observed at doses ≥ 30mg/kg/day, which were maternally toxic. The
NOAEL for skeletal malformations was associated with a plasma esketamine exposure (AUC) that was
≥110 mmHg 13 (4%) 1 (0.5%) --- ---
0.3 times the AUC exposure at MRHD of 84 mg/day.
≥25 mmHg increase 46 (13%) 6 (3%) 10 (14%) 2 (3%)
Administration of esketamine to pregnant rats during pregnancy and lactation at intranasal doses
In studies for the treatment of depressive symptoms in adults with MDD with acute suicidal ideation equivalent to 4.5, 15, and 45 mg/kg/day (based on a 200-gram rat) produced AUC exposures 0.07,
or behavior, patients treated with SPRAVATO plus oral antidepressants demonstrated similar mean 0.5, and 0.7 times the MRHD of 84 mg/day, respectively. Maternal toxicity was observed at doses
placebo-adjusted increases in SBP and DBP compared to patient with TRD, as well as similar rates ≥ 15 mg/kg/day. In addition, a dose-dependent delay in the age of attainment of Preyer response reflex
of increases to SBP ≥180 mmHg or ≥40 mmHg increases in SBP, and similar rates of increases to was observed in pups at all doses during the preweaning period. This sensory/motor developmental
DBP ≥110 mmHg or ≥25 mmHg increases in DBP, compared to the TRD study results in Table 6. measure was tested starting on postnatal day (PND) 9, and the effect normalized by PND 19 in
Nausea and Vomiting treatment groups as compared with PND 14 for the majority of the control animals. There is no NOAEL
SPRAVATO can cause nausea and vomiting. Most of these events occurred on the day of dosing and for this delay in sensory/motor response observed in pups during the preweaning period. During the
resolved the same day, with the median duration not exceeding 1 hour in most subjects across dosing postweaning period, a decrease in motor activity was observed at doses ≥ 15 mg/kg which is 0.5-times
sessions. Rates of reported nausea and vomiting decreased over time across dosing sessions from the human exposure at the MRHD of 84 mg/day. The NOAEL for maternal toxicity and decreased
the first week of treatment in the short-term studies, as well as over time with long-term treatment. motor activity during the postweaning period was 4.5 mg/kg/day which was associated with a plasma
Table 7 presents the incidence and severity of nausea and vomiting in a short-term study with patients exposure (AUC) that was 0.07-times the AUC exposure at MRHD of 84 mg/day.
with TRD. Lactation
Table 7: Incidence and Severity of Nausea and Vomiting in a Double-blind, Randomized, Placebo- Risk Summary
Controlled, Fixed-Dose Study in Adult Patients with TRD Esketamine is present in human milk. There are no data on the effects of SPRAVATO on the breastfed
infant or on milk production. Published studies in juvenile animals report neurotoxicity (see Data).
Nausea Vomiting Because of the potential for neurotoxicity, advise patients that breast-feeding is not recommended
Treatment (+ Oral AD)
N All Severe All Severe during treatment with SPRAVATO.
SPRAVATO 56 mg 115 31 (27%) 0 7 (6%) 0 Data
SPRAVATO 84 mg 116 37 (32%) 4 (3%) 14 (12%) 3 (3%) Published juvenile animal studies demonstrate that the administration of drugs that block NMDA
Placebo Nasal Spray 113 12 (11%) 0 2 (2%) 0 receptors, such as ketamine, during the period of rapid brain growth or synaptogenesis, results in
widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic
In studies for the treatment of depressive symptoms in adults with MDD with acute suicidal ideation morphology and neurogenesis. Based on comparisons across species, the window of vulnerability to
or behavior, patients demonstrated similar incidence and severity of reported nausea and vomiting these changes is believed to correlate with exposures in the third trimester of gestation through the first
compared to the TRD study results described above. several months of life, but this window may extend out to approximately 3 years of age in humans.

SPRAVATO® (esketamine) nasal spray, CIII
Females and Males of Reproductive Potential

Contraception
Based on published animal reproduction studies, SPRAVATO may cause embryo-fetal harm when
administered to a pregnant woman [see Warnings and Precautions and Use in Specific Populations].
However, it is not clear how these animal findings relate to females of reproductive potential treated
with the recommended clinical dose. Consider pregnancy planning and prevention for females of
reproductive potential during treatment with SPRAVATO.
Pediatric Use
The safety and effectiveness of SPRAVATO in pediatric patients have not been established. Clinical
studies of SPRAVATO in pediatric patients have not been conducted.
Geriatric Use
Of the total number of patients in Phase 3 clinical studies exposed to SPRAVATO, (N=1601), 194 (12%)
were 65 years of age and older, and 25 (2%) were 75 years of age and older. No overall differences
in the safety profile were observed between patients 65 years of age and older and patients younger
than 65 years of age.
The mean esketamine Cmax and AUC values were higher in elderly patients compared with younger
adult patients [see Clinical Pharmacology (12.3) in Full Prescribing Information].
The efficacy of SPRAVATO for the treatment of TRD in geriatric patients was evaluated in a 4-week,
randomized, double-blind study comparing flexibly-dosed intranasal SPRAVATO plus a newly initiated
oral antidepressant compared to intranasal placebo plus a newly initiated oral antidepressant in
patients ≥ 65 years of age. SPRAVATO was initiated at 28 mg twice weekly and could be titrated to
56 mg or 84 mg administered twice-weekly. At the end of four weeks, there was no statistically
significant difference between groups on the primary efficacy endpoint of change from baseline to
Week 4 on the Montgomery-Åsberg Depression Rating Scale (MADRS).
Hepatic Impairment
The mean esketamine AUC and t1/2 values were higher in patients with moderate hepatic impairment
compared to those with normal hepatic function [see Clinical Pharmacology (12.3) in Full Prescribing
Information]. SPRAVATO-treated patients with moderate hepatic impairment may need to be monitored
for adverse reactions for a longer period of time.
SPRAVATO has not been studied in patients with severe hepatic impairment (Child-Pugh class C). Use in
this population is not recommended [see Clinical Pharmacology (12.3) in Full Prescribing Information].
DRUG ABUSE AND DEPENDENCE
Controlled Substance
SPRAVATO contains esketamine hydrochloride, the (S)-enantiomer of ketamine and a Schedule III
controlled substance under the Controlled Substances Act.
Abuse
Individuals with a history of drug abuse or dependence may be at greater risk for abuse and misuse of
SPRAVATO. Abuse is the intentional, non-therapeutic use of a drug, even once, for its psychological or
physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual
in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Careful
consideration is advised prior to use of individuals with a history of substance use disorder, including
alcohol.
SPRAVATO may produce a variety of symptoms including anxiety, dysphoria, disorientation, insomnia,
flashback, hallucinations, and feelings of floating, detachment and to be “spaced out”. Monitoring for
signs of abuse and misuse is recommended.
Abuse Potential Study
A cross-over, double-blind abuse potential study of SPRAVATO and ketamine was conducted in
recreational polydrug users (n=34) who had experience with perception-altering drugs, including
ketamine. Ketamine, the racemic mixture of arketamine and esketamine, is a Schedule III controlled
substance and has known abuse potential. In this study, the mean “Drug Liking at the Moment” and
“Take Drug Again” scores for single doses of intranasal SPRAVATO (84 mg and 112 mg – the maximum
recommended dose and 1.3 times the maximum recommended dose, respectively) were similar to
these scores in the intravenous ketamine (0.5 mg/kg infused over 40 minutes) control group. However,
these scores were greater in the SPRAVATO and ketamine groups compared to the placebo group. The
112 mg dose of intranasal SPRAVATO was associated with significantly higher scores for
“Hallucinating,” “Floating,” “Detached,” and “Spaced Out” than the 84 mg dose of intranasal
SPRAVATO and the intravenous ketamine dose.
Dependence
Physical dependence has been reported with prolonged use of ketamine. Physical dependence is a
state that develops as a result of physiological adaptation in response to repeated drug use, manifested
by withdrawal signs and symptoms after abrupt discontinuation or significant dosage reduction of a
drug. There were no withdrawal symptoms captured up to 4 weeks after cessation of esketamine
treatment. Withdrawal symptoms have been reported after the discontinuation of frequently used
(more than weekly) large doses of ketamine for long periods of time. Such withdrawal symptoms are
likely to occur if esketamine were similarly abused. Reported symptoms of withdrawal associated with
daily intake of large doses of ketamine include craving, fatigue, poor appetite, and anxiety. Therefore,
monitor SPRAVATO-treated patients for symptoms and signs of physical dependence upon the
discontinuation of the drug.
Tolerance has been reported with prolonged use of ketamine. Tolerance is a physiological state
characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a
drug is required to produce the same effect that was once obtained at a lower dose). Similar tolerance
would be expected with prolonged use of esketamine.
OVERDOSAGE
Management of Overdosage
There is no specific antidote for esketamine overdose. In the case of overdose, the possibility of
multiple drug involvement should be considered. Contact a Certified Poison Control Center for the most
up to date information on the management of overdosage (1-800-222-1222 or www.poison.org).
Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560
© 2019 Janssen Pharmaceutical Companies
cp-81105v6

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SUNY Upstate Medical University, Syracuse
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Allan Tasman, MD
Professor and Emeritus Chair, Department of Psychiatry and EDITORIAL
Behavioral Sciences, University of Louisville School of Medicine
A
Associate Editorial Director..................... Heidi Anne Duerr, MPH
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lbert Einstein once said, “Intellectual growth should commence at
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Professor, Integrated Medicine and Psychiatric Services; Associate
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Renato D. Alarcón, MD, MPH John J. Miller, MD, sets the stage with his editorial, a personal reflection
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PSY1020_008_HouseAd.indd 8 9/30/20 11:06 AM

O C TO B E R 2 0 2 0 PS YC H I ATRI C TI M E S 9
CLINICAL
FROM THE EDITOR ANXIETY & STRESS
The Practice
DISORDERS
30 Managing Distress in Health Care
Workers During COVID-19: Lessons
of Medicine From a Disaster Trauma Lens

Gertie Quitangon, MD
John J. Miller, MD | Editor in Chief 10.2020 VOLUME 37 NUMBER 10 NEUROPSYCHIATRY

33 Easy To Miss, Hard to Treat:
Notes on Frontotemporal Dementia
F
or me, the fall has always con-
jured excitement about a new
COVER STORIES Rajesh R. Tampi, MD, MS, DFAPA, DFAAGP,
Deena J. Tampi, MSN, MBA-HCA, RN,
Presidential Election Anxiety DFAAGP, and Michael Parish, MD
odyssey of learning. With the
and the Role of Psychiatry
first days of school came both ex- H. Steven Moffic, MD
citement and fear, wondering if I
had the ability to learn all that was Is the Country Experiencing a
expected of me. During the previous Mental Health Pandemic?
COLUMNS
academic year, I had listened with Ronald W. Pies, MD MOOD DISORDERS
awe as students in the grade ahead BIPOLAR UPDATE
of mine discussed their subject mat- 32 Oxcarbazepine: Does It Have
ter, and each year I wondered how I a Role in Bipolar Disorder?
FROM THE CHAIRMAN David N. Osser, MD
could ever learn that complex mate- 07 The Importance of Learning
rial. One memory in particular re- Mike Hennessy Sr MEDICAL ECONOMICS
mains alive and well, and it visits 13 The Ethics of Reopening
me a few times each year. FROM THE EDITOR Tia Powell, MD
I was in the first grade at St 09 The Practice of Medicine
James Elementary School, a paro- DR MILLER is Medical Director, John J. Miller, MD POETRY OF THE TIMES
chial elementary school in Salem, Brain Health, Exeter, NH; Editor in 26 I Don’t Want to Die
MA. An intimidating nun informed Chief, Psychiatric Times; Staff Here in Timbuktu
Psychiatrist, Seacoast Mental Richard M. Berlin, MD
us we would be learning the com-
plete alphabet. Fear filled me as I Health Center, Exeter, NH; CATEGORY 1 CME
Consulting Psychiatrist, Exeter 38 Between Stoned and a Hard
anticipated what felt like the impos- Place? Navigating Cannabis
Hospital, Exeter, NH; Consulting
sibility of learning all 26 letters of
Psychiatrist, Insight Meditation Medicolegal Issues COMMENTARY
the alphabet. Somehow, I succeed- Chandler Hicks, DO, Maria Lapchenko, DO,
Society, Barre, MA. ADDICTION & SUBSTANCE USE
ed, and these 26 letters have served Adrienne Saxton, MD, and Sara West, MD
36 The Case for
me well over the years. Medication-Assisted
course started with the accretion of Treatment: An Ethical Priority
the planet earth from stardust and Kultaj Kaleka, RN, and Juliette M.
Each academic year had its own CASE REPORT
moved through the theoretical pro- Perzhinsky, MD, MSc
curriculum to be mastered, and
cesses that created the molecules SCHIZOPHRENIA & PSYCHOSIS
each course of study initially 28 Documenting Recovery ANXIETY & STRESS
that eventually would become the
seemed impossible: building blocks of life. in Delusional Disorder With DISORDERS
 Learning to construct a sentence Reflecting on that experience, I the MMPI-2 37 Behind Closed Doors
Alan D. Blotcky, PhD Omar Reda, MD
with nouns, verbs, and adjectives. realized that if the necessary ele-
 Understanding the history of the ments were all present, learning
SPECIAL REPORT
United States as it was taught at could be fun, meaningful, and could
that time. actually be driven by passion. Sev-
eral of these elements are unique to
 Playing a simple melody on a each person. Arguably, being ex- Forensic Psychiatry, Part II
xylophone. posed to a wide-ranging curriculum
Special Report Chair: James L. Knoll IV, MD
 Becoming familiar with the during the high school years in-
periodic table of the elements in creases the likelihood that each stu- 14 Assessing Competency to Stand Trial
chemistry. dent will discover their passion, and Barry Wall, MD, and Ruby Lee, MD
 Writing a complete term paper, hopefully they will be given the op-
16 Psychopathy: Insights for General Practice
with references expected. portunity to follow it.
Barbara Burton, MD, and Fabian M. Saleh, MD
During my 12 years of study in
It was not until the second semes- college, medical school and psychi-
ter of my sophomore year of college atry residency, I naively expected
at the University of Massachusetts that I would ultimately learn all that
COVER IMAGE: RRICE@STOCK.ADOBE.COM
Amherst that something shifted in- I would need to become a competent

side of me, and the fear of learning clinical psychiatrist. Today, 29 years
new material transformed into a after completing my residency in
passion to learn more. The class psychiatry and applying great effort © 2020 MultiMedia Medical LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic
or mechanical including by photocopy, recording, or information storage and retrieval without permission in writing from the publisher. Authorization to
was “Molecular Evolution,” the first to keep up to date with our rapidly photocopy items for internal/educational or personal use, or the internal/educational or personal use of specific clients is granted by MJH Life Sciences
course specific to my major of bio- evolving field, I feel like I have only for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 fax 978-646-8700
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chemistry. Walking from my dorm mastered the first 5 letters of the “al- or email: etemple-morris@mmhgroup.com
room to the classroom I felt ener- phabet” of psychiatry. I am intrigued Psychiatric Times ® (ISSN 0893-2905) is published monthly by MultiMedia Healthcare LLC, 2 Clarke Drive, Suite 100 Cranbury, NJ 08512.
gized and excited about what the and curious about the remaining 21 Periodicals postage paid at Trenton, NJ 08650 and additional mailing offices.
next lesson would teach me. The (CONTINUED ON PAGE 13) POSTMASTER: Please send address changes to Psychiatric Times ® MJH Life Sciences, PO Box 457, Cranbury NJ 08512-0457.
PSY1020_009_013_Editorial-TOC.indd 9 9/30/20 11:15 AM

C A P LY TA F O R S C H I Z O P H R E N I A
I N A D U LT S
THIS ISN’T JUST A COFFEE RUN.
Important Safety Information

Boxed Warning: Elderly patients with dementia-related • Tardive Dyskinesia, a syndrome of potentially irreversible,
psychosis treated with antipsychotic drugs are at an dyskinetic, and involuntary movements which may increase as
increased risk of death. CAPLYTA is not approved for the the duration of treatment and total cumulative dose increases.
treatment of patients with dementia-related psychosis. The syndrome can develop after a relatively brief treatment period,
even at low doses. It may also occur after discontinuation of treatment.
Contraindications: CAPLYTA is contraindicated in patients with Given these considerations, CAPLYTA should be prescribed in a manner
known hypersensitivity to lumateperone or any components of most likely to reduce the risk of tardive dyskinesia. Discontinue
CAPLYTA. Reactions have included pruritus, rash (e.g. allergic CAPLYTA if clinically appropriate.
dermatitis, papular rash, and generalized rash), and urticaria.
• Metabolic Changes, including hyperglycemia, diabetes mellitus,
Warnings & Precautions: Antipsychotic drugs have been dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme
reported to cause: and associated with ketoacidosis, hyperosmolar coma or death, has
• Cerebrovascular Adverse Reactions in Elderly been reported in patients treated with antipsychotics. Measure weight
Patients with Dementia-Related Psychosis, including and assess fasting plasma glucose and lipids when initiating CAPLYTA
stroke and transient ischemic attack. See Boxed Warning above. and monitor periodically during long-term treatment.
• Neuroleptic Malignant Syndrome, which is a potentially • Leukopenia, Neutropenia, and Agranulocytosis
fatal reaction. Signs and symptoms include: hyperpyrexia, muscle rigidity, (including fatal cases). Perform complete blood counts in
delirium, autonomic instability, elevated creatinine phosphokinase, patients with pre-existing low white blood cell count (WBC) or history
myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage of leukopenia or neutropenia. Discontinue CAPLYTA if clinically
with immediate discontinuation of CAPLYTA and provide intensive significant decline in WBC occurs in absence of other causative
symptomatic treatment and monitoring. factors.
PSY1020_010-012_Caplyta.indd 10 9/28/20 1:39 PM

Choose CAPLYTA to help control
IT’S REAL your patients’ symptoms with low
rates of side effects1
PROGRESS. • In clinical trials, the most common adverse reactions
were somnolence/sedation (24%) and dry mouth (6%)1
• Orthostatic Hypotension and Syncope. Monitor heart Drug Interactions: Avoid concomitant use with CYP3A4 inducers,
rate and blood pressure and warn patients with known cardiovascular moderate or strong CYP3A4 inhibitors and UGT inhibitors.
or cerebrovascular disease. Orthostatic vital signs should be monitored
in patients who are vulnerable to hypotension.
Special Populations: Neonates exposed to antipsychotic drugs during
the third trimester of pregnancy are at risk for extrapyramidal and/or
• Falls. CAPLYTA may cause somnolence, postural hypotension, withdrawal symptoms following delivery. Breastfeeding is not recommended.
and motor and/or sensory instability, which may lead to falls and, Avoid use in patients with moderate or severe hepatic impairment.
consequently, fractures and other injuries. Assess patients for
risk when using CAPLYTA.
Adverse Reactions: The most common adverse reactions in
clinical trials with CAPLYTA vs. placebo were somnolence/sedation
• Seizures. Use CAPLYTA cautiously in patients with a history of (24% vs. 10%) and dry mouth (6% vs. 2%).
seizures or with conditions that lower seizure threshold. Please see the accompanying Brief Summary of Prescribing Information on the following page.
• Potential for Cognitive and Motor Impairment. Advise Reference: 1. CAPLYTA prescribing information, 2019.
patients to use caution when operating machinery or motor vehicles
until they know how CAPLYTA affects them. SEE ITS EFFICACY AT CAPLYTAHCP.COM
• Body Temperature Dysregulation. Use CAPLYTA with
caution in patients who may experience conditions that may increase
core body temperature such as strenuous exercise, extreme heat,
dehydration, or concomitant anticholinergics.
• Dysphagia. Use CAPLYTA with caution in patients at risk
for aspiration. CAPLYTA is a trademark of Intra-Cellular Therapies, Inc. © 2020 Intra-Cellular Therapies, Inc. All rights reserved. 05/2020 US-CAP-1900006

Brief Summary of Full Prescribing Information. WBC or ANC or a history of drug-induced leukopenia or neutropenia, perform a ritonavir, nelfinavir. CYP3A4 Inducers: Concomitant use of CAPLYTA with CYP3A4
complete blood count (CBC) frequently during the first few months of therapy. In inducers decreases the exposure of lumateperone. Avoid concomitant use of
CAPLYTA™ (lumateperone) capsules, for oral use such patients, consider discontinuation of CAPLYTA at the first sign of a clinical- CAPLYTA with CYP3A4 inducers. Examples of CYP3A4 inducers include:
Initial U.S. Approval: 2019 ly significant decline in WBC in the absence of other causative factors. Monitor Carbamazepine, phenytoin, rifampin, St. John’s wort, bosentan, efavirenz, etravirine,
patients with clinically significant neutropenia for fever or other symptoms or modafinil, nafcillin, aprepitant, armodafinil, pioglitazone, prednisone. UGT Inhibitors:
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH signs of infection and treat promptly if such symptoms or signs occur. Discontinue Concomitant use of CAPLYTA with UGT inhibitors may increase the exposure of
DEMENTIA-RELATED PSYCHOSIS CAPLYTA in patients with absolute neutrophil count < 1000/mm3 and follow their lumateperone and/or its metabolites. Avoid concomitant use of CAPLYTA with UGT
Elderly patients with dementia-related psychosis treated with antipsychotic WBC until recovery. inhibitors. Examples of UGT inhibitors include: Valproic acid, probenecid
drugs are at an increased risk of death. CAPLYTA is not approved for the Orthostatic Hypotension and Syncope: Atypical antipsychotics cause orthostat- USE IN SPECIFIC POPULATIONS
treatment of patients with dementia-related psychosis. ic hypotension and syncope. Generally, the risk is greatest during initial dose
administration. In these clinical trials the frequencies of orthostatic hypotension for Pregnancy: Pregnancy Exposure Registry - There is a pregnancy exposure registry
INDICATIONS AND USAGE CAPLYTA and placebo were 0.7% and 0%, respectively. The rates of syncope for that monitors pregnancy outcomes in women exposed to atypical antipsychotics,
CAPLYTA is indicated for the treatment of schizophrenia in adults. CAPLYTA and placebo were 0.2% and 0.2%. Orthostatic vital signs should be mon- including CAPLYTA, during pregnancy. Healthcare providers are encouraged
itored in patients who are vulnerable to hypotension (e.g., elderly patients, patients to register patients by contacting the National Pregnancy Registry for Atypical
CONTRAINDICATIONS Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/
CAPLYTA is contraindicated in patients with history of hypersensitivity reaction to with dehydration, hypovolemia, and concomitant treatment with antihypertensive
medications), patients with known cardiovascular disease (history of myocardial clinical-and-research-programs/-pregnancyregistry/. Risk Summary - Neonates ex-
lumateperone. Reactions have included pruritus, rash (e.g. allergic dermatitis, posed to antipsychotic drugs during the third trimester are at risk for extrapyramidal
papular rash, and generalized rash), and urticaria. infarction, ischemic heart disease, heart failure, or conduction abnormalities), and
patients with cerebrovascular disease. CAPLYTA has not been evaluated in patients and/or withdrawal symptoms following delivery. Available data from case reports on
WARNINGS AND PRECAUTIONS with a recent history of myocardial infarction or unstable cardiovascular disease. CAPLYTA use in pregnant women are insufficient to establish any drug associated
Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly Such patients were excluded from pre-marketing clinical trials. risks for birth defects, miscarriage, or adverse maternal or fetal outcomes. There
patients with dementia-related psychosis treated with antipsychotic drugs are at an Falls: Antipsychotics, including CAPLYTA, may cause somnolence, postural are risks to the mother associated with untreated schizophrenia and with exposure
increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of hypotension, and motor and sensory instability, which may lead to falls and, to antipsychotics, including CAPLYTA, during pregnancy. In animal reproduction
10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of consequently, fractures and other injuries. For patients with diseases, conditions studies, no malformations were observed with oral administration of lumateperone
death in the drug-treated patients of between 1.6 to 1.7 times that in placebo-treated or medications that could exacerbate these effects, complete fall risk assessments to pregnant rats and rabbits during organogenesis at doses up to 2.4 and 9.7 times,
patients. Over the course of a typical 10-week controlled trial, the rate of death in when initiating antipsychotic treatment and periodically during long-term treatment. respectively, the maximum recommended human dose (MRHD) of 42 mg/day on
drug-treated patients was about 4.5%, compared to a rate of about 2.6% in placebo- a mg/m2 basis. When pregnant rats were administered lumateperone during the
Seizures: Like other antipsychotic drugs, CAPLYTA may cause seizures. The risk period of organogenesis through lactation, the number of perinatal deaths of pups
treated patients. Although the causes of death were varied, most of the deaths is greatest in patients with a history of seizures or with conditions that lower the
appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious was increased at 4.9 times the MRHD, with no adverse effects on pups at 2.4 times
seizure threshold. Conditions that lower the seizure threshold may be more the MRHD. The estimated background risk of major birth defects and miscarriage
(e.g., pneumonia) in nature. CAPLYTA is not approved for the treatment of patients prevalent in older patients.
with dementia-related psychosis. for the indicated population is unknown. All pregnancies have a background risk
Potential for Cognitive and Motor Impairment: CAPLYTA, like other antipsychotics, of birth defect, loss, or other adverse outcomes. In the U.S. general population,
Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with may cause somnolence and has the potential to impair judgment, thinking, and
Dementia-Related Psychosis: In placebo-controlled trials in elderly subjects with the estimated background risk of major birth defects and miscarriage in clinically
motor skills. In short-term (i.e., 4- to 6-week) placebo-controlled clinical trials of recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Consider-
dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a patients with schizophrenia, somnolence and sedation were reported in 24% of
higher incidence of stroke and transient ischemic attack, including fatal stroke. ations - Disease associated maternal and/or embryo/fetal risk: There is risk to the
CAPLYTA-treated patients, compared to 10% of placebo-treated patients. Patients mother from untreated schizophrenia, including increased risk of relapse, hospital-
CAPLYTA is not approved for the treatment of patients with dementia-related should be cautioned about operating hazardous machinery, including motor vehi-
psychosis. ization, and suicide. Schizophrenia is associated with increased adverse perinatal
cles, until they are reasonably certain that therapy with CAPLYTA does not affect outcomes, including preterm birth. It is not known if this is a direct result of the
Neuroleptic Malignant Syndrome: Neuroleptic Malignant Syndrome (NMS), a them adversely. illness or other comorbid factors. Fetal/neonatal adverse reactions: Extrapyramidal
potentially fatal symptom complex, has been reported in association with admin- Body Temperature Dysregulation: Atypical antipsychotics may disrupt the body’s and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor,
istration of anti-psychotic drugs. Clinical manifestations of NMS are hyperpyrexia, ability to reduce core body temperature. Strenuous exercise, exposure to extreme somnolence, respiratory distress, and feeding disorder have been reported in
muscle rigidity, delirium, and autonomic instability. Additional signs may include heat, dehydration, and anticholinergic medications may contribute to an elevation in neonates who were exposed to antipsychotic drugs during the third trimester of
elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute core body temperature; use CAPLYTA with caution in patients who may experience pregnancy. These symptoms have varied in severity. Monitor neonates for extra-
renal failure. If NMS is suspected, immediately discontinue CAPLYTA and provide these conditions. pyramidal and/or withdrawal symptoms and manage symptoms appropriately.
intensive symptomatic treatment and monitoring.
Dysphagia: Esophageal dysmotility and aspiration have been associated with Some neonates recovered within hours or days without specific treatment; others
Tardive Dyskinesia: Tardive dyskinesia, a syndrome consisting of potentially antipsychotic drug use. Antipsychotic drugs, including CAPLYTA, should be used required prolonged hospitalization. Data - Animal Data: Pregnant rats were treated
irreversible, involuntary, dyskinetic movements, may develop in patients treat- cautiously in patients at risk for aspiration. with oral doses of 3.5, 10.5, 21, and 63 mg/kg/day lumateperone (0.8, 2.4, 4.9,
ed with antipsychotic drugs. The risk appears to be highest among the elderly, and 14.6 times the MRHD on a mg/m2 basis) during the period of organogenesis.
especially elderly women, but it is not possible to predict which patients are like- ADVERSE REACTIONS No malformations were observed with lumateperone at doses up to 2.4 times the
ly to develop the syndrome. Whether antipsychotic drug products differ in their The following adverse reactions are discussed in detail in other sections of the MRHD. Findings of decreased body weight were observed in fetuses at 4.9 and 14.6
potential to cause tardive dyskinesia is unknown. The risk of tardive dyskinesia labeling: Increased Mortality in Elderly Patients with Dementia-Related Psycho- times the MRHD. Findings of incomplete ossification and increased incidences of
and the likelihood that it will become irreversible increase with the duration of treat- sis; Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with visceral and skeletal variations were recorded in fetuses at 14.6 times the MRHD, a
ment and the cumulative dose. The syndrome can develop after a relatively brief Dementia-related Psychosis; Neuroleptic Malignant Syndrome; Tardive Dyskinesia; dose that induced maternal toxicity. Pregnant rabbits were treated with oral doses
treatment period, even at low doses. It may also occur after discontinuation of Metabolic Changes; Leukopenia, Neutropenia, and Agranulocytosis; Orthostatic of 2.1, 7, and 21 mg/kg/day lumateperone (1.0, 3.2, and 9.7 times the MRHD on
treatment. Tardive dyskinesia may remit, partially or completely, if antipsychotic Hypotension and Syncope; Falls; Seizures; Potential for Cognitive and Motor Impair- a mg/m2 basis) during the period of organogenesis. Lumateperone did not cause
treatment is discontinued. Antipsychotic treatment itself, however, may suppress ment; Body Temperature Dysregulation; Dysphagia. adverse developmental effects at doses up to 9.7 times the MRHD. In a study in
(or partially suppress) the signs and symptoms of the syndrome, possibly mask- Clinical Trials Experience: Because clinical trials are conducted under widely varying which pregnant rats were administered oral doses of 3.5, 10.5, and 21 mg/kg/day
ing the underlying process. The effect that symptomatic suppression has upon the conditions, adverse reaction rates observed in the clinical trials of a drug cannot lumateperone (0.8, 2.4, and 4.9 times the MRHD on a mg/m2 basis) during the
long-term course of tardive dyskinesia is unknown. Given these considerations, be directly compared to rates in the clinical trials of another drug and may not period of organogenesis and through lactation, the number of live-born pups was
CAPLYTA should be prescribed in a manner most likely to reduce the risk of reflect the rates observed in practice. The safety of CAPLYTA has been evaluated decreased at 2.4 and 4.9 times the MRHD, and early postnatal deaths increased at
tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved in 1724 adult patients with schizophrenia exposed to one or more doses. Of a dose 4.9 times the MRHD. Impaired nursing and decreased body weight gain in
for patients: 1) who suffer from a chronic illness that is known to respond to these patients, 811 participated in short-term (4- to 6-week), placebo-controlled pups were observed at 4.9 times, but not at 2.4 times, the MRHD. Pregnant rats
antipsychotic drugs; and 2) for whom alternative, effective, but potentially less trials with doses ranging from 14 to 84 mg/day. A total of 329 CAPLYTA-exposed were treated with a human metabolite of lumateperone (reduced ketone metabolite)
harmful treatments are not available or appropriate. In patients who do require patients had at least 6 months of exposure and 108 had at least 1 year of exposure at oral doses of 15, 60, and 100 mg/kg/day (1.2, 19, and 27 times the exposure
chronic treatment, use the lowest dose and the shortest duration of treatment to the 42-mg dose of CAPLYTA. There was no single adverse reaction leading to to this metabolite at the MRHD of lumateperone based on AUC plasma exposure)
producing a satisfactory clinical response. Periodically reassess the need for discontinuation that occurred at a rate of >2% in CAPLYTA-treated patients. The during the period of organogenesis. This metabolite did not cause adverse devel-
continued treatment. If signs and symptoms of tardive dyskinesia appear in a most common adverse reactions (incidence of at least 5% of patients exposed to opmental effects at a dose 1.2 times the exposure at the MRHD of lumateperone;
patient on CAPLYTA, drug discontinuation should be considered. However, some CAPLYTA and greater than twice the rate of placebo) are somnolence/sedation and however, it caused an increase in visceral malformations (cleft palate) at 27 times
patients may require treatment with CAPLYTA despite the presence of the syndrome. dry mouth. Adverse reactions associated with CAPLYTA (incidence of at least 2% in and skeletal malformations at 19 times the exposure at the MRHD of lumateperone,
Metabolic Changes: Antipsychotic drugs have caused metabolic changes, including patients exposed to CAPLYTA and greater than placebo) are shown in Table 1. The a dose that induced maternal toxicity.
hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Although all of following findings are based on the pooled short-term (4- to 6-week), placebo- Lactation: Risk Summary - There are no available data on the presence of lumateperone
the drugs in the class have been shown to produce some metabolic changes, controlled studies in adult patients with schizophrenia in which CAPLYTA was or its metabolites in human milk or animal milk, the effects on the breastfed infant, or
each drug has its own specific risk profile. Hyperglycemia and Diabetes Mellitus - administered at a daily dose of 42 mg (N=406). Table 1 in the full Prescribing the effects on milk production. Toxicity in animals has been linked to the formation of
Hyperglycemia, in some cases extreme and associated with ketoacidosis, Information displays Adverse Reactions Reported in ≥2% of CAPLYTA-Treated aniline metabolites of lumateperone. Although aniline metabolites were not present
hyperosmolar coma or death, has been reported in patients treated with Patients in 4- to 6-week Schizophrenia Trials. Adverse reaction is followed by in (adult) humans at quantifiable levels, it is unknown whether infants exposed to
antipsychotics. There have been reports of hyperglycemia in patients treated percentage of patients treated with CAPLYTA 42mg (N=406) and Patients treated lumateperone will exhibit comparable lumateperone metabolism and elimination
with CAPLYTA. Assess fasting plasma glucose before or soon after initiation of with Placebo (N=412) in parentheses. Somnolence/ Sedation (24%, 10%); Nausea pathways as adults. In addition, there are published reports of sedation, failure to
antipsychotic medication and monitor periodically during long-term treatment. (9%, 5%); Dry Mouth (6%, 2%); Dizziness1 (5%, 3%); Creatine Phosphokinase thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle
In pooled data from short-term (4- to 6-week), placebo-controlled trials of adult Increased (4%, 1%); Fatigue (3%, 1%); Vomiting (3%, 2%); Hepatic Transami- movements) in breastfed infants exposed to antipsychotics. Based on findings of
patients with schizophrenia, mean changes from baseline and the proportion of nases Increased2 (2%, 1%); Decreased Appetite (2%, 1%). 1 Dizziness, dizziness toxicity in animal studies and the potential for serious adverse reactions in the breast-
patients with shifts from normal to greater than normal levels of fasting glucose postural; 2 ALT, AST, “hepatic enzymes” increased, or liver function test abnormal. fed infant, breastfeeding is not recommended during treatment with lumateperone.
in patients treated with CAPLYTA were similar to those in patients treated with Dystonia: Symptoms of dystonia, prolonged abnormal contractions of mus-
placebo. In an uncontrolled open-label trial of CAPLYTA for up to 1 year in Females and Males of Reproductive Potential: Infertility - Based on findings from
cle groups, may occur in susceptible individuals during the first few days of animal studies, lumateperone may impair male and female fertility.
patients with stable schizophrenia, the percentages of patients with shifts in fasting treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes
glucose and insulin values from normal to high were 8% and 12%, respective- Pediatric Use: Safety and effectiveness of CAPLYTA have not been established in
progressing to tightness of the throat, swallowing difficulty, difficulty breathing, pediatric patients.
ly. 4.7% of patients with normal hemoglobin A1c (<6.5%) at baseline developed and/or protrusion of the tongue. Although these symptoms can occur at low doses,
elevated levels (≥6.5%) post-baseline. Dyslipidemia - Antipsychotics have caused they occur more frequently and with greater severity with high potency and higher Geriatric Use: Controlled clinical studies of CAPLYTA did not include any patients
adverse alterations in lipids. Before or soon after initiation of antipsychotic med- doses of first-generation antipsychotic drugs. An elevated risk of acute dystonia is aged 65 or older to determine whether or not they respond differently from younger
ications, obtain a fasting lipid profile at baseline and monitor periodically during observed in males and younger age groups. patients. Antipsychotic drugs increase the risk of death in elderly patients with
treatment. In pooled data from short-term (4- to 6-week), placebo-controlled trials dementia-related psychosis. CALYPTA is not approved for the treatment of patients
Extrapyramidal Symptoms: In the 4- to 6-week, placebo-controlled trials, the fre- with dementia-related psychosis.
of adult patients with schizophrenia, mean changes from baseline and the proportion quency of reported events related to extrapyramidal symptoms (EPS), including
of patients with shifts to higher levels of fasting total cholesterol and triglycerides akathisia, extrapyramidal disorder, muscle spasms, restlessness, musculoskeletal Hepatic Impairment: Use of CAPLYTA is not recommended for patients with
were similar in patients treated with CAPLYTA and placebo. In an uncontrolled stiffness, dyskinesia, dystonia, muscle twitching, tardive dyskinesia, tremor, drooling, moderate (Child-Pugh class B) to severe hepatic impairment (Child-Pugh class C).
open-label trial of CAPLYTA for up to 1 year in patients with stable schizophrenia, and involuntary muscle contractions was 6.7% for CAPLYTA and 6.3% for placebo. In Patients with moderate and severe hepatic impairment experienced higher exposure
the percentages of patients with a shift from normal to high were 8%, 5%, and 4% the 4- to 6-week trials, data were collected using the Simpson Angus Scale (SAS) for to lumateperone. No dosage adjustment is recommended for patients with mild
for total cholesterol, triglycerides, and LDL cholesterol, respectively. Weight Gain - EPS (total score ranges from 0 to 40), the Barnes Akathisia Rating Scale (BARS) for hepatic impairment (Child-Pugh A).
Weight gain has been observed with use of antipsychotics. Monitor weight akathisia (total score ranges from 0 to 14), and the Abnormal Involuntary Movement
at baseline and frequently thereafter. In pooled data from placebo-controlled OVERDOSAGE
Scale (AIMS) for dyskinesia (total score ranges from 0 to 28). The mean changes No specific antidotes for CAPLYTA are known. In managing overdose, provide
trials of adult patients with schizophrenia, mean changes from baseline and from baseline for CAPLYTA-treated patients and placebo-treated patients were 0.1
the proportion of patients with an increase in weight ≥7% from baseline to supportive care, including close medical supervision and monitoring and consider
and 0 for the SAS, -0.1 and 0 for the BARS, and 0.1 and 0 for the AIMS, respectively. the possibility of multiple drug involvement. In case of overdose, consult a Certified
end of study was similar in patients treated with CAPLYTA and placebo. In an
uncontrolled open-label trial of CAPLYTA for up to 1 year in patients with stable DRUG INTERACTIONS Poison Control Center (1-800-222-1222 or www.poison.org).
schizophrenia, the mean change in body weight was approximately -2 kg (SD 5.6) Table 2 in the full Prescribing Information displays Drugs Having Clinically Distributed by Intra-Cellular Therapies, Inc.
at Day 175 and approximately - 3.2 kg (SD 7.4) at Day 350. Important Interactions with CAPLYTA. Moderate or Strong CYP3A4 Inhibitors: New York, NY 10016
Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia and neutropenia Concomitant use of CAPLYTA with moderate or strong CYP3A4 inhibitors increases
lumateperone exposure, which may increase the risk of adverse reactions. Avoid CAPLYTA is a trademark of Intra-Cellular Therapies, Inc.
have been reported during treatment with antipsychotic agents, including CAPLYTA.
Agranulocytosis (including fatal cases) has been reported with other agents in the concomitant use of CAPLYTA with moderate or strong CYP3A4 inhibitors. Exam- © 2020 Intra-Cellular Therapies, Inc.
class. Possible risk factors for leukopenia and neutropenia include pre-existing ples of CYP3A4 inhibitors include: Moderate inhibitors - Amprenavir, ciprofloxacin, All rights reserved
low white blood cell count (WBC) or absolute neutrophil count (ANC) and history cyclosporine, diltiazem, erythromycin, fluconazole, fluvoxamine, verapamil. Strong
of drug-induced leukopenia or neutropenia. In patients with a pre-existing low inhibitors - Clarithromycin, grapefruit juice, itraconazole, voriconazole, nefazodone, US-CAP-2000254

o cto b er 2020 PS YC H I ATRI C TI M E S 13
Continued from Page 9 know, and consult with a colleague usually evolves into a specific area of educational opportunities to support us
who likely knows more than I do, practice that fits like a comfortable in our ongoing, self-directed learning.
letters, and I try to remain aware of when necessary. One of the many glove. It is our responsibility as phy- We at Psychiatric Times® are excited
their current contribution and appli- to invite our readers, and in fact all
cation to clinical psychiatry, but in all psychiatric providers, to join us later
honesty it is hard. this month in our Annual Psychiatric
Hence the term practice of medi-
"Even with all the right elements of Times® World CME Conference™. It
cine. Even with all the right elements interest, commitment, passion, and will be held virtually this year from
of interest, commitment, passion, October 15th through 17th. We feel priv-
and effort, my view is that it is not effort, in my view it is not humanly possible ileged to have top-quality faculty who
humanly possible to ever master psy- to ever master psychiatry. We simply will present on a wide range of topics.
chiatry. We simply must keep on The conference is directed to psychiat-
practicing, learning new information, must keep on practicing, learning new ric clinicians and will offer a wide
and honing new skills. information, and honing new skills." range of presentations that run from 15
But such is the case in every field to 30 minutes in length. Our hope is
of study, and why should medicine be that participants will be eager to apply
any different? Our primary responsi- gifts of psychiatry as a field of medi- sicians, however, to remain up to date what they have learned immediately
bility is to do no harm. In many clin- cine is its extreme diversity. The with what is happening in our field of after the conference.
ical situations this requires me to menu of specialty options we have in psychiatry in general. So please, we would love it if you
know what I know, know what I don’t the field is vast, and each psychiatrist Fortunately, there is no paucity of would come and learn with us! ❒
For more information on our Annual Psychiatric Times® World CME Conference™ and to register, please click on the
LEARN MORE following link: www.gotoper.com/conferences/psychtimes/meetings/psychtimes20conference
FROM THE PAGES OF
The Ethics of Reopening

» Tia Powell, MD sion-making process, not one based
on fear or biases. It is an ethical imper-
and has been proven to work—is
transparent and honest information.
and death rates have dropped dramat-
ically, from more than 20 per day at
D
uring the fight against coronavi- ative to state the estimated results of Historically, risk communication its peak to fewer than 5.
rus disease 2019 (COVID-19), various interventions clearly, whether has been a challenge for the medical Transparency, and ultimately hon-
every American has made daily or not those results are favorable to a community, but big data and artificial esty, will help Americans make deci-
choices that could affect their health, particular political ideology. A failure intelligence (AI) can provide a useful sions based on data and facts, not on
their family’s health, and the health of to root decisions in data and analysis c h a n n e l fo r c o m muni cat i ng fear and bias. Throughout this jour-
their larger community. The deci- ultimately leads to moral failures. COVID-19-related information to ney, the governor of Rhode Island
sion-making process can feel uncer- and public health officials were very
tain and chaotic, especially when the clear about what the risks were, the
science around this virus is constantly "Transparency, and ultimately honesty, will challenges the state was facing, and
evolving. At some level, every indi- the struggles everyone was going
vidual, business owner, and politician help Americans make decisions based on through. Despite all that uncertainty,
is grappling with the same questions. data and facts, not fear and bias." the state still made impressive prog-
Unfortunately, much of the dialogue ress in containing the virus.
around reopening the country lacks This morally sound approach can
the empirical and ethical foundations During past crises, we have seen both employees and employers. My protect human life and also preserve
necessary to return to normalcy in a how those moral failures have played current work with Buoy Health and the economic opportunities individu-
sustainable way. out. Fear during the AIDS crisis led its Back with Care platform—an AI als need to survive. Honest assess-
The country cannot flourish un- to rampant discrimination against the tool designed to help employers re- ment of data and best practices en-
less we have both population and lesbian, gay, bisexual, transgender, open safely—is motivated by the ables individuals to respond better to
economic health. Fortunately, these 2 and queer (LGBTQ) community, in need to incorporate as much trans- changing circumstances. Strategies
goals are not really in conflict. The addition to an irrational fear of indi- parency as possible into the reopen- can shift and evolve as new informa-
strategy to maintain the safety and viduals from specific countries, most ing process for businesses. tion emerges. This pandemic has
financial well-being of our country notably Haiti. After September 11th, When leadership follows the data, made it crystal clear that what works
must be based on the best available the nation saw an uptick in hate good outcomes will follow. In Rhode 1 week may not work the next, and as
data. It must be acquired and ana- crimes against Sikhs, a religious Island, the smallest state in the coun- those facts on the ground change, so
lyzed through rational processes, group with no connection to the at- try, businesses are reopening and un- should the response to those facts.
rather than wishful thinking. Individ- tacks on our country, in addition to employment is falling. Why? Rather
uals, business owners, and politicians attacks on Muslims, millions of than ignore the impacts of the virus, Dr Powell is a bioethicist and psychi-
all face an incredibly complex puz- whom are peaceful and productive state leadership looked at what we atrist who directs the Center for
Bioethics and Masters in Bioethics at
zle, but data and technology can help American citizens. None of the fear knew about the pandemic and acted
Montefiore Health Systems and Albert
us reopen the economy and preserve and violence against these groups accordingly. The state mandated in- Einstein College of Medicine, and is a
the public’s health at the same time. made Americans safer. tensive testing, tracing, and isolation, fellow of the Hastings Center. She is
Politics in the United States are in These irrational responses to un- and they broadcasted clear messages also a member of the Buoy Health
an incredibly polarized state, which is precedented circumstances arise from about the importance of wearing Back with Care advisory board. ❒
in itself a serious problem. Reopening fear, and they are unproductive at the masks. Now, Rhode Island has one of
must be rooted in a rational deci- end of the day. What is productive— the best testing rates in the country Read more: https://bit.ly/2DKYFei
PSY1020_009_013_Editorial-TOC.indd 13 9/30/20 11:15 AM

14 P S Y C H I AT R I C T I M E S
w w w. p s y c h i a t r i c t i m e s . c o m SPECIALREPORT OCTOBER 2020
IN THIS
SPECIAL REPORT
Special Report Chairperson

James L. Knoll IV, MD
14 Assessing Competency
to Stand Trial
Barry Wall, MD, and
Ruby Lee, MD
16 Psychopathy: Insights
for General Practice
Barbara Burton, MD, and
Fabian M. Saleh, MD
FORENSIC PSYCHIATRY PART 2

Assessing Competency To Stand Trial
» Barry Wall, MD, and Ruby Lee, MD community. Thus, the gap in tradi-
tional treatment services in the com-
records in addition to a thorough clini-
cal interview. Police reports, medical
defendant, conducted after the al-
leged criminal incident has occurred.
T
he United States legal system munity results in the overuse of the records from jail, prior competency In contrast, a criminal responsibility
has long recognized that crimi- CST-CR system.4 Public mental evaluations, and information shared by evaluation determines the mental
nal defendants must be compe- health care systems are in crisis, and the lawyer are some of the data that are state of the defendant at certain point
tent to stand trial (CST) prior to pro- increasingly they must devote dol- an integral part of the competency eval- in the past, specifically at the time of
ceeding with the legal process to lars to those facing criminal charges uation although they are not included in the alleged criminal incident. Addi-
allow for fairness for the accused and for costly forensic evaluations and typical psychiatric evaluations. tionally, CST trial is moment specif-
protect the integrity of the justice sys- lengthy state hospitalization stays.5 In addition to assessing the defen- ic. Therefore, a defendant could be
tem. Trying a defendant who is un- The minimum legal standard for dant’s psychiatric, medical, and so- initially recommended as CST and
able to assist in their own defense competency to stand trial was set cial histories, the defendant’s compe- later, as the case progresses, may be-
would call into question the dignity of by the US Supreme Court in Dusky tence as it relates to trial-related tasks come IST. In fact, the issue of com-
the proceedings and render the adver- v United States.6 In 1960, the court is evaluated. This includes assessing petency can be raised at any point in
sarial process unfair. Psychiatrists and determined that “it is not enough an understanding of the charges and the court process.
psychologists assist courts by evaluat- for the district judge to find that their potential consequences, an un-
ing defendants’ CST and, when nec- ‘the defendant [is] oriented to time derstanding of the trial process,
essary, providing treatment to restore and place and [has] some recollec- knowledge about the various partici- CASE EXAMPLE
competency in defendants initially tion of events,’ but that the ‘test pants in a trial, and whether the de-
found to be incompetent to stand trial must be whether he has sufficient fendant has the ability to help in their “John,” a 35-year-old man with a
(IST). The term competence resto- present ability to consult with his own defense and make decisions history of schizoaffective disorder, is
ration (CR) is used to describe the lawyer with a reasonable degree of about their case.7,8 arrested; he has been treatment non-
treatment and education process used rational understanding—and CST is a present tense evaluation, adherent for several months. Once
to transform the defendants classified whether he has a rational as well as meaning it is an evaluation that deter- detained, he is restarted on treat-
as IST to CST (Table 1).1 factual understanding of the pro- mines the current mental state of the ment. By the time the evaluators saw
CST, therefore, is a legal deci- ceedings against him.’”
sion made by a judge that deter- Defense attorneys have concerns
mines if a criminal defendant is able regarding their client’s competency in Table 1. Important Competency Terms
to proceed with the legal process. It about 8% to 15% of felony prosecu-
is also called adjudicative compe- tions, and it is estimated that about CST - Competent to stand trial
tence or fitness to proceed. It is the 20% to 30% of evaluated defendants Mental ability to stand trial; a person is mentally competent to stand trial
most commonly conducted crimi- are found incompetent to stand trial.1 if they are able to understand the character and consequences of the
nal forensic evaluation in the United If a judge determines a defendant is proceedings against them and is able properly to assist in their defense.
States. There has been a surge in CST, the legal case proceeds. If the IST - Incompetent to stand trial
CST evaluation requests in recent judge determines a defendant is IST,
MAKIBESTPHOTO@STOCK.ADOBE.COM
Mentally incompetent to stand trial; a person is mentally

years, with current estimates of the CR process begins, typically in incompetent to stand trial if they are unable to understand
160,000 or more evaluation re- the form of both treatment of the de- the character and consequences of the proceedings against
quests annually.2,3 This increase fendant’s mental illness and compe- them or are unable properly to assist in their defense.
may be due to the criminalization of tency education (Figure). CR - Competence restoration
mental illness, substance abuse, and A CST evaluation is first and fore- To be considered restored and competent to stand trial, a
intellectual disability, all of which most a clinical evaluation. As with all defendant must be able to consult with their defense lawyer and
often stem from the lack of ade- psychiatric evaluations, a CST evalu- have a rational and factual understanding of the legal proceedings.
quate access to civil treatment in the ation includes a review of medical
PSY1020_014-017_SReport.indd 14 9/30/20 8:59 AM

15
OCTOBER 2020
FORENSIC PSYCHIATRY P S Y C H I AT R I C T I M E S
w w w. p s y c h i a t r i c t i m e s . c o m
Table 2. Common Competency and that a clinical evaluation cannot a factual understanding of the case managed to get probation.
Assessment Tools be replaced by a competency assess- (such as case travel, various pleas, Tony violates a no contact order,
ment instrument, consider the fol- etc), the law student’s ability to ap- and because of his history of intellec-
CAI - Competency Assessment Instrument lowing case. ply the information to her own case tual disability, his competency to
13 areas of functioning
would be impaired, as she does not stand trial is questioned. After an
Takes about 1 hour
“Jodi,” a 25-year-old law student with have a rational understanding of the evaluation, including a clinical evalu-
Scoring not standardized
a long history of treatment nonadher- situation. She is viewing the situa- ation and the CAST-MR, it is clear that
GCCT - Georgia Court Competence Test ence, once again stops her medication through a psychotic process. he has an understanding of the
21 items that fall into 3 domains tions because they made her thinking This defendant would also be recom- charges and their potential conse-
Takes about 10 minutes “too slow.” She becomes increasingly mended as IST, despite her in-depth quences. Plus, as a result of years of
CAST-MR paranoid. On a particularly bad day, knowledge of the law, as she was un- experience in the court system, Tony
Competence Assessment for Standing Trial Jodi calls the police for backup, as able to comport her behavior appro- also has a good handle on the trial
for Defendants with Mental Retardation she believes that people are walking priately in the civil mental health process. He tells you that he is inter-
50 questions around downtown with bombs in court. By extrapolation, if the crimi- ested in accepting a deal, because it
backpacks. The police arrive as she is nal court judge ordered a CST evalu- will allow him to avoid going to jail.
being arrested—she was trying to ation, she would likely be recom- Tony further explains he would prefer
him in jail, John was no longer take a backpack from a passerby, be- mended to the court as IST because to admit to some form of guilt to be
SPECIALREPORT
thought-disordered because his con- lieving a bomb to be inside. she was unable to work with her at- quickly paroled so that he can see his
dition had improved with treatment. Since she refuses medication, the torney in civil court due to mental newborn child.
He, therefore, had an understanding treatment team requests the court to illness symptoms.
of his charges and potential conse- medicate despite objection. During Although there are no diagnoses
quences. However, given his history the hearing in mental health court to that equal IST, psychosis and intel- This case illustrates that an intel-
of mental illness and his bizarre be- determine treatment, Jodi, being a lectual disability are the 2 most com- lectual disability does not automati-
havior at the time of the arrest, a CST law student, starts to question the mon clinical reasons that defendants cally equate with incompetence. Pri-
evaluation was ordered. psychiatrist. She is well versed in the are found incompetent to stand trial. or experience in the legal system
John was recommended as CST, requirements that are needed for in- Nonetheless, a defendant with would be an important factor in this
which was accepted by the court. voluntary medication, and she insists schizophrenia can be competent and, case. The defendant had repeated ex-
However, as months passed, the de- on cross examining the psychiatrist, similarly, a defendant with intellectu- posure to the system, giving him a lot
fendant started having difficulty despite the judge advising her to deal disability can be competent. Con- of practical experience. As such, it is
sleeping and became increasingly fer to her attorney. sider the following case example. likely that he would be competent to
paranoid. He ultimately stopped tak- stand trial, even though he has an in-
ing his medicines. When his defense “Tony” is a 25-year-old man who has tellectual disability.
attorney tried to meet with him, John In such a case, a law student who been in and out of the legal system
began muttering under his breath is knowledgeable about the legal sys- since he was a teenager. He was not Concluding thoughts
that the lawyer was conspiring with tem would do well on scoring instru- a high school graduate; he dropped Currently, public mental health ser-
the judge and the police. ments. However, in undergoing a out in the middle of tenth grade as he vices are inundated with court refer-
thorough CST evaluation, the evalu- no longer wanted to go to school. He rals for CST evaluations. When de-
ator would realize that the defendant successfully worked with his attorney fendants are IST, the CST-CR system
In the above scenario, the defen- is paranoid and likely unable to assist on several other misdemeanors, both often cannot keep up with demand.
dant was disorganized during the time in her own defense despite having a in family court as a juvenile and in the This has resulted in wait lists for
of arrest, but by the time the CST strong factual base of knowledge. criminal court system as an adult. He competency-related services for jail
evaluation was ordered, he was back Therefore, while the law student has has never served time, as he always detainees. States have been sued for
on medications and was overall func-
tioning well. Therefore, he was first
recommended as CST. However, Figure. Example of the CST Process
once he stopped taking his medica-
tions in jail, he became psychotic, re- IST COMMITMENT PROCESS
fused to work collaboratively with his
Defendant returns to court. If
attorney, and believed the legal sys- substantial evidence is presented
Defendant’s competency has Defendant is given an evaluation
tem was conspiring against him. At on defendant’s incompetency, then
been questioned by attorney(s). and, if needed, treatment.
that point, if a second evaluation were a competency hearing is scheduled.
ordered, he would likely be found IST
and remanded for CR services.
There are multiple competency
assessment instruments that supple-
ment clinical evaluations (Table 2). Generally, those accused of
While these formalized checklists misdemeanors are handled in an
and structured interviews can assist outpatient setting or released. If the defendant is found
evaluators with competency assess- incompetent, community Competency hearing held
ments, they do not replace a thorough mental health program which includes 1 or 2 psychiatrists
clinical evaluation. Some examples director is ordered by a who testify on their evaluation of
court to evaluate the best the defendant.
include the Competency Assessment
Instrument (CAI), the Georgia Court Generally, those accused of place to restore competency.
Competence Test (GCCT), and the felonies wait in county jail to be
Competence Assessment for Stand- transferred to a state hospital
ing Trial for Defendants with Mental to receive IST treatment.
IST = Incompetent to stand trial.
Retardation (CAST-MR).8
To illustrate how critical the clini- Source: Legislative Analyst’s Office, The California Legislature’s Nonpartisan Fiscal and Policy Advisor. Accessed September 2, 2020.
cal evaluation is in CST evaluations, https://lao.ca.gov/reports/2012/hlth/ist/incompetent-stand-trial-010312.aspx

16 P S Y C H I ATR I C T I M E S
w w w. p s y c h i a t r i c t i m e s . c o m FORENSIC PSYCHIATRY October 2020
KEY POINTS Psychopathy: Insights

for General Practice
 CST evaluations assess a defendant’s cur-
rent abilities to assist with their legal case.
 These evaluations are present tense and
can be requested at any time during the
legal process, since a defendant’s
competency may change at various
points in time.
» Barbara Burton, MD, and Fabian M. Saleh, MD in multiple cognitive domains, including atten-
tion, judgement of risk and reward, and the emo-
P
 T here is no diagnosis that automatically sychopathy is a personality disorder charac- tional processing.5,6 The brains of individuals
renders a defendant IST. terized by lack of empathy, grandiosity, with psychopathy have identifiable structural and
N
o competence test can substitute for a shallow affect, deceitfulness, impulsivity, functional differences from the brains of those
thorough clinical competence evaluation. irresponsibility, and disregard for the well-being without, which appear to account for some of the
or rights of others. Few syndromes in medicine cognitive and behavioral manifestations of the
 T he current CST-CR system is have carved as deep of a niche in human cultural disorder. Reduced gray matter volumes in the
SPECIALREPORT
overwhelmed and needs reform.

thought as the one occupied by psychopathy. The amygdala and multiple areas of the prefrontal
 The legal test for CST is whether mythos of the psychopath is born of both in extre- cortex have been described. On fMRI, psycho-
defendants are presently suffering from a mis of its infamous case examples and of past de- pathic brains have exhibited dysfunctional activ-
mental illness rendering them unable to ficiencies in the empirical research. However, the ity in the default mode network, including limbic
understand the proceedings against them scientific landscape for psychopathy has expand- and paralimbic structures.7 People with psychop-
or to assist properly in their defense. ed significantly over recent decades, and discourse athy have also been found to exhibit impaired
around treatment has become more optimistic. communication between the visual prefrontal
cortex and the amygdala.8 Increased activity in
Terminology the ventral striatum in the context of reward ex-
being unable to admit IST defendants for CR While the terms psychopath, sociopath, and anti- pectancy has also been described in association
services in a timely fashion. Better collabora- social are often used inter- with criminal activity among
tion between the criminal justice and clinical changeably by clinicians, those with psychopathy.9
care systems could improve services for per- they are not equal. Psychopa-
sons with serious mental illness in the legal
system.4,9,10
thy and sociopathy both de-
scribe the same personality
“People with Clinical presentation
Unsurprisingly, psychopathic
syndrome. However, many psychopathy have personalities are identified
experts identify them as sepa- more frequently in forensic
Dr Wall is a clinical psychiatrist, treating pa-
tients in the Providence, Rhode Island area. He rate but overlapping entities also been found to than community settings. The
with distinct etiological odds of encountering a patient
is also a clinical professor at Brown University
and provides expert witness consultations for mechanisms.1 Psychopathy exhibit impaired with psychopathy in the gen-
medical-legal purposes. Dr Lee is clinical assis-
tant professor of psychiatry at Brown
remains empirically the better
described of the 2 and is the communication eral outpatient setting, how-
ever, are significant. As with
University, and is the assistant program director term most often used to de-
note the cluster of personality
between the visual other personality syndromes,
these patients often present to
of the Forensic Psychiatry Fellowship and assis-
tant director of the forensic service at Slater traits in question.
The term antisocial is of-
prefrontal cortex a psychiatrist seeking treat-
ment for a comorbid condi-
Hospital, Rhode Island’s only state hospital.
ten clinically used as a short- and the amygdala.” tion, and only through careful
hand reference to the DSM-V assessment does the character
REFERENCES
1. Noffsinger SG, Resnick PJ. Criminal Competencies. In: Rosner diagnosis of antisocial per- pathology become apparent
R and CL Scott, eds. Principles and Practice of Forensic Psychia- sonality disorder (ASPD), to the clinician. Psychopathy
try, 3rd ed. Taylor & Francis; 2017. which is based almost entirely on behaviors. A is most often associated with substance use disor-
2. Poythress NG, Bonnie RJ, Hoge SK, et al. Client abilities to as- lack of empathy and disregard for the safety of ders and with other Cluster B personality syn-
sist counsel and make decisions in criminal cases: findings from
three studies. Law Hum Behav. 1994;18:437-452. others are neither necessary nor sufficient for the dromes, such as narcissistic personality disorder.2
3. Department of Justice, FBI. Uniform Crime Report: Crime in the diagnosis. In contrast, psychopathy is a set of per- The impairment caused by this condition
United States, 2018. Fall 2019. Accessed September 1, 2020. sonality traits which may or may not be associat- should not be underestimated. In the forensic set-
https://ucr.fbi.gov/crime-in-the-u.s/2018/crime-in-the-u.s.-2018 ed with obvious misconduct. It must not be as- ting, this is usually evident. In the community,
4. Callahan L, Pinals DA. Challenges to Reforming the Compe-
tence to Stand Trial and Competence Restoration System. Psychi-
sumed that an individual who meets diagnostic however, impairment may be less conspicuous.
atr Serv. 2020;71(7):691-697. criteria for ASPD also has psychopathic/socio- Deficits in attention and risk-reward assessment
5. Gowensmith WN. Resolution or resignation: the role of forensic pathic personality traits, because this is often not may result in harmful financial decisions, poor
mental health professionals amidst the competency services the case.2 judgement at work, gambling, and other impulsive
crisis. Psychol Public Policy Law. 2019; 25:1-14.
6. Dusky v United States. 362 US 402; 1960.
behaviors. Callousness, deceitfulness, and grandi-
7. Poythress N, Bonnie R, Monahan J, Otto R. Adjudicative Com- Epidemiology and neurobiology osity may lead to brief and combustive relation-
petence: The MacArthur Studies. Kluwer Academic/ Plenum Psychopathy seems to have some degree of he- ships. One may encounter a patient who cannot
Studies; 2002. reditability, although genetic and epigenetic fac- seem to maintain employment despite ability and
8. Wall BW, Ash P, Keram E, Pinals DA, Thompson CH. AAPL prac-
tors are not entirely sufficient to account for dis- qualification; instrumentally engages socially
tice resource for the forensic psychiatric evaluation of compe-
tence to stand trial. J Am Acad Psychiatry Law. 2018;46(3):373. order. A prevalence of between 15% to 25% has with others and is undisturbed when relationships
9. Gowensmith WN, Frost LE, Speelman DW, et al. Lookin’ for been described in incarcerated populations, and fall apart; and exhibits a pattern of poor decision
beds in all the wrong places: outpatient competence restoration approximately 1% in the general population, with making accompanied by a psychological scotoma
as a promising approach to modern challenges. Psychol Public a male to female ratio of about 3:1.3 One study for personal responsibility. Psychopathic person-
Policy Law. 2016;22:293-305.
10. Fuller DA, Sinclair E, Lamb Human Resources, et al. Emptying found 4% of corporate managers exhibited signif- ality traits may also present adaptively in one do-
the “New Asylums”: A Beds Capacity Model to Reduce Mental icant psychopathic traits.4 main of life, such as a boardroom10, and maladap-
illness Behind Bars. Treatment Advocacy Center; 2017. ❒ Psychopathy has been associated with deficits tively in another, such as marriage.

17
October 2020
FORENSIC PSYCHIATRY P S Y C H I ATR I C T I M E S
Diagnosis PCL-R and PCL-SV may help guide the condition is capable of respond- fourth year psychiatry resident at Beth
The gold standard instrument for as- formulation, the diagnosis of psy- ing to treatment. Although data are Israel Deaconess Medical Center in
sessing psychopathy is the Hare Psy- chopathy in the general outpatient still limited, the treatment of psy- Boston, MA. She will be matriculating
chopathy Checklist Revised or setting must be made carefully and chopathy has begun to gain traction to the forensic psychiatry fellowship
PCL-R.11 In the forensic setting, per- only with substantial amounts of data as a target for clinical research. The program at the University of
formance of the PCL-R is accompa- Massachusetts Medical School.
nied by extensive collateral investiga- REFERENCES
tion, psychiatric interview, and
review of the individual’s medical, “While incarceration is the definitive ‘treatment’ for 1. Walsh A, Wu H-H. Differentiating antisocial personal-
ity disorder, psychopathy, and sociopathy: evolutionary,
social, and criminal history. There is some, psychopathy exists on a spectrum like any other genetic, neurological, and sociological considerations.
Criminal Justice Studies. 2008;21(2):135-152.
also a screening version of the
PCL-R, the PCL-SV, which can be mental disorder; more recent research suggests the 2. Werner, KB, Few, LR., Bucholz, KK. Epidemiology,
comorbidity, and behavioral genetics of antisocial
performed outside of the specialized
forensic setting (Table).12 The PLC-R condition is capable of responding to treatment.” personality disorder and psychopathy. Psychiatr Ann.
2015;45(4):195-199.
3. Hart, SD, Storey, JE. Clinical and forensic issues in the
and its derivatives have demonstrated assessment of psychopathy. In: Weiner, IB, eds. Handbook
good interrater reliability and can po- of Psychology. John Wiley & Sons, Inc; 2013: 556-578.
tentially be useful when leveraged by gathered through the physician-pa- substantial evidence supporting the 4. Babiak, P, Neumann, CS, Hare, RD. Corporate psy-
SPECIALREPORT
objective and ethical evaluators who tient relationship over time. existence of cognitive and emotional chopathy: Talking the walk. Behav Sci Law.
2010;28(2):174-193..
are trained to interpret the instru- The differential diagnosis for psy- processing deficits in people with 5. Anderson, NE, Steele, VR, Maurer, JM, Rao, V, Koe-
ments and to provide honest and im- chopathy includes a personality dis- psychopathy suggests that these are nigs, MR, Decety, J, Kosson, DS, Calhoun, VD, Kiehl, KA.
partial professional opinions. How- turbance due to another mental illness potential treatment targets. Indeed, 2017. Differentiating emotional processing and atten-
ever, concerns have been raised about or physical condition. For example, cognitive behavioral and cognitive tion in psychopathy with functional neuroimaging. .
Cogn Affect Behav Neurosci. 2017;17(3):491-515.
the susceptibility of the tests to bias individuals with frontotemporal de- remediation techniques have shown
6. Baskin-Sommers AR, Curtin JJ, Newman JP. Altering
when performed by individuals who mentia may present with impulsive some promise.6,17,18 Some have also the Cognitive-Affective Dysfunctions of Psychopathic and
lack this expertise.13 These tools have behavior and an apparent lack of re- suggested that the interpersonal and Externalizing Offender Subtypes with Cognitive Remedi-
also exhibited wide variability in gard for others. Autism spectrum dis- affective symptoms of psychopathy ation. Clin Psychol Sci. 2015;3(1):45-57.
7. Johanson M, Vaurio O, Tiihonen J, Lähteenvuo M. A
their ability to predict future violence orders may also present with impaired may be amenable to modified dialec-
Systematic Literature Review of Neuroimaging of
and their use in the assessment of risk mentalization and apparent lack of tical behavioral therapy techniques.19 Psychopathic Traits. Front Psychiatry. 2020;10:1027
must be approached with caution. empathy. Psychotic illnesses may Data are limited regarding the use of 8. Contreras-Rodríguez O, Pujol J, Batalla I, et al. Dis-
There are significant ethical concerns produce a flattened affect with the ap- medication to target psychopathic rupted neural processing of emotional faces in psychop-
athy. Soc Cogn Affect Neurosci. 2014;9(4):505-512
regarding the potential misuse of pearance of shallow or blunted emo- personality traits. The best approach
9. Geurts DE, von Borries K, Volman I, Bulten BH, Cools R,
these tests in legal and clinical deci- tional responses. Patients who are to pharmacotherapy is to target and Verkes RJ. Neural connectivity during reward expectation
sion making when the fate of an indi- dependent on a substance may exhib- treat comorbid psychiatric disorders. dissociates psychopathic criminals from non-criminal
vidual’s liberty or the safety of others it manipulativeness and recklessness individuals with high impulsive/antisocial psychopathic
traits. Soc Cogn Affect Neurosci. 2016;11(8):1326-1334.
is at stake.14,15 While the items in the when their disorder is decompensat- Conclusion 10. Steinert SW, Lishner DA, Vitacco MJ, Hong PY.
ed, and then improve when receiving Although it may be daunting to en- Conceptualizing successful psychopathy: An elabora-
Table. Items in the Screening appropriate treatment. counter a patient with psychopathy in tion of the moderated-expression model. Aggression
Version of the Hare The concept of psychopathy in pe- the general practice setting, this syn- and violent behavior. 2017;36:44-51.
11. Hare RD. The Psychopathy Checklist–Revised,
Psychopathy Checklist- diatric patients is complex and contro- drome is well defined and can be ap-
2nd ed. Multi Health System; 2003.
Revised (PCL-SV) versial. Psychopathy is similar to oth- proached clinically in a manner sim- 12. Hare RD, Hart SD, Cox DN. The Hare PCL:SV—
er personality disorders in that it is not ilar to other personality disorders. Psychopathy Checklist Screening Version. Multi-
1 Superficial diagnosed prior to adulthood, due to Essential elements include examina- Health Systems; 1995.
13. Hare RD. Psychopathy, the PCL-R, and criminal jus-
the fluidity of personality traits during tion of the history and patient’s moti-
2 Grandiose tice: Some new findings and current issues. Canadian
early development and the inability to vation for care, assessment and treat- Psychology/psychologie Canadienne. 2016;57(1):21-34.
3 Deceitful predict which children will go on to ment of comorbid conditions, and 14. DeMatteo D, Hart SD, Heilbrun K, et al. Statement
develop a disorder and which will not. collaboration with family members of concerned experts on the use of the Hare Psychop-
athy Checklist—Revised in capital sentencing to as-
4 Lacks remorse Furthermore, multiple items in the and other treatment providers. Psy-
sess risk for institutional violence. Psychol Public
adult diagnostic criteria are predicat- chopathy is associated with an in- Policy Law. 2020;26(2):133-144.
5 Lacks empathy ed on the patient having had sufficient creased risk of violence; however, 15. Singh JP, Fazel S, Gueorguieva R, Buchanan A.
Does not accept years of life to fulfill them (such as this relationship is more complex Rates of violence in patients classified as high risk by
6 parasitic lifestyle or multiple short- than it appears and remains the sub- structured risk assessment instruments. Br J Psychi-
responsibility atry. 2014;204(3):180-187.
term marital relationships). Any as- ject of ongoing research.20 As neuro- 16. Larsen RR. Psychopathy Treatment and the Stig-
7 Impulsive sessment of psychopathic traits in a logical and psychological investiga- ma of Yesterday’s Research. Kennedy Inst Ethics J.
child or adolescent patient must be tions continue, the future appears more 2019;29(3):243-272.
8 Poor behavioral controls 17. Sewall LA, Olver ME. Psychopathy and treatment
approached with extreme caution. promising than previously thought.
outcome: Results from a sexual violence reduction
9 Lacks goals program. Personal Disord. 2019;10(1):59-69.
Treatment Dr Saleh is a child & adolescent and fo- 18. Wong SCP, Gordon A, Gu D, Lewis K, Olver ME. The
10 Irresponsible A perilous belief once persisted in the rensic psychiatrist. He is the director of effectiveness of violence reduction treatment for psy-
scientific community that psychopa- the Sexual Violence Prevention & Risk chopathic offenders: Empirical evidence and a treat-
Adolescent antisocial ment model. International Journal of Forensic Mental
11
behavior
thy was not only untreatable, but that Management Program at Beth Israel Health. 2012;11:336-349.
attempting to treat a psychopath was Deaconess Medical Center, and a 19. White BA, Oliver ME, Lilienfeld SO. Psychopathy:
12 Adult antisocial behavior affirmatively harmful.16 While incar- Harvard Medical School faculty. His Its relevance, nature, assessment, and treatment. The
ceration is the definitive “treatment” forensic practice focuses on criminal Behavior Therapist. 2016;39(5):154-161.
Items are assigned scores of 0 (does not 20. Camp JP, Skeem JL, Barchard K, Lilienfeld SO,
apply), 1 (somewhat applies), or 2 for some, psychopathy exists on a and civil cases including sex offender, Poythress NG. Psychopathic predators? Getting spe-
(definitely applies), with a score >= 18
considered indicative of psychopathy. spectrum like any other mental disor- threat, competency, and criminal re- cific about the relation between psychopathy and vio-
Adapted from: Hare et al. (1995). der; more recent research suggests sponsibility assessments. Dr Burton is lence. J Consult Clin Psychol. 2013;81(3):467-480. ❒
Understanding Adult Fire Setting, Pyromania, and Arson

READ MORE AT PSYCHIATRICTIMES.COM Josephine Collins, MSc, Nichola Tyler, PhD, MSc, and Magali Fleur-Barnoux, PhD, CPsychol

18 PSYCH I AT R I C T I M ES Oc tobe r 2020
www.psych i a t r i c t i m e s. c o m
Presidential Election Anxiety

species. One way that anxiety can do
this is to organize our cognitive func-
Continued from Cover tions quickly in response to danger.
Additionally, another thesis is that
chronic anxiety can be a driver of ge-
How might mental health professionals Figure 1. Psychiatrist Anxiety About the Upcoming Elections nius.12 Anxiety can also be a negative
potentially assess and address this reinforcer that encourages the social-
“election anxiety”? I am very worried, and I am
doing something about it 43% ization necessary for survival and re-
production, because anxiety is general-
Election anxiety polls ly most intense when we are isolated.13
The polls confirm our intuition: we 39% I am very worried, but I am
not doing anything about it
are a nervous nation. Earlier this A history of election anxiety
year, the American Psychological
Association conducted a “Stress in 12% I am concerned, but not terribly so
Reviewing some historical elections
may be informative, and perhaps re-
America” survey 2, in which they assuring, as we approach this upcom-
found more than half (about 56%)
respondents identified the 2020 elec-
4% I pay no attention to politics ing election.
A clear parallel can be drawn be-
tion as a significant stressor. At the tween our upcoming election and the
end of June, the Centers for Disease Figure 2. Patient Anxiety About the Upcoming Elections election of 1920. It was during another
Control reported that the highest ris- devastating pandemic, the so-called
ing levels of anxiety were among
young adults, as well as black and
My patients are very concerned 78% “Spanish flu” that began in 1918.
(President Trump’s grandfather died
Latino people of all ages. The preva- of this flu.) The worst of it was over
lence of anxiety symptoms among all 9% My patients do not seem to be bothered or concerned by 1920, and the Republican nomi-
populations was 3 times higher than nee, Warren Harding, ran and won on
the corresponding period in 2019.3
Certain groups of minorities, espe-
12% I do not know; I avoid this topic a “return to normalcy” platform. His
message resonated with the elector-
cially educated and higher-earning ate, and he seemed to reduce the pub-
black males, are at risk for more anxi- Perception is a key for both anxiety pation model.10 This is a feedback lic’s fears. He was viewed positively
ety.4 This possibly counterintuitive and fear because the threat can be an model, in which there is either a dis- while president but died only about 2
finding may stem from blocked oppor- imagined one. If anxiety is punctuat- rupted cognitive estimation of proba- years into his term. Soon after he
tunities, which in turn may be related to ed by acute episodes of fear, such as bility and cost of a future threat, or died, his reputation fell amid multiple
the higher implicit bias of white men.5 fear-mongering political campaign heightened subjective feelings about scandals, stemming from his habit of
Anxiety also seems to differ along ads, it can feel like a one-two punch negative future events. That it is a giving government jobs to friends.
partisan party lines. About two-thirds to our sense of security. feedback model suggests why it is Our society today is split along
of recent Joe Biden supporters say The physical and psychological difficult to stop until neuroplasticity ideological, racial, and class lines.
they are scared about the country’s symptoms of anxiety, such as feeling develops new anxiety pathways. The same was true during the elec-
future, compared to about one-third tense or having trouble concentrat- Although many individuals are tion of 1968. On March 31, 1968,
of President Donald Trump’s supporting, can be so uncomfortable that overly anxious, others may not be President Lyndon Johnson announced
ers.6 Of course, these sources of anx- they cause behavioral changes. Fight anxious enough given the circum- that not only was he partially halting
iety can change, and change quickly, or flight stress responses range from stances. They suffer from inadequate the United States bombing of Viet-
depending on societal developments. avoidance to aggression, as well as anxiety. Inadequate anxiety can lead nam, but also that he would not seek
In our Psychiatric Times polls self-medicating with alcohol and to ignoring various risks and, in this the nomination for president. Al-
(Figures 1 and 2) inquiring about the street drugs. Peaceful protests in case, not voting. Those individuals though his withdrawal offered hope
upcoming elections, the trend was presidential elections can reflect a who have sociopathic tendencies tend for reconciliation, that dissipated
clearly slanted toward being very normal and appropriate expression of to have less anxiety, which in turn quickly. Only 5 days later, Martin
worried, with about half of respon- anxiety, such as is emerging virtually may allow them to manipulate indi- Luther King Jr was killed. Only a
dents doing something productive with the “Rage Moms,” who are fed viduals with higher anxiety levels.11 couple of months after that, Robert F.
about it and half not. As far as our pa- up with being teacher, caregiver, em- If there is an appropriate amount Kennedy, who was running for the
tients are concerned, the second poll ployee, and parent all at the same of anxiety, it would be an amount Democratic nominee, was murdered.
suggested a similarly strong degree of time. When protests turn into riots, proportionate to the assessment of The nomination of Hubert Humphrey
concern. If these trends hold up, the however, they may be a reflection in future danger, which in itself is diffi- occurred during a violent, conflictual
anxiety level would be even higher in part of too much anxiety, an overre- cult to predict and may change over convention in Chicago. Richard Nix-
our psychiatric world than in the action to perceived threats. Similarly, time. Therefore, appropriate anxiety on won the presidency with a law-
greater society. police may have appropriate anxiety is a moving target. It needs regular and-order message and a (secret)
for their role and risk, or not. monitoring and recalibration. plan to end the war in Vietnam. Nix-
Varieties of anxiety There are several kinds of anxiety. on knew what millions of Americans
Anxiety refers to a prolonged state of Given the power of the presidency, a The deep history of anxiety were worried about, and he promised
apprehension brought on by uncer- presidential election may tend to Anxiety has apparently persisted to eliminate the sources of their fear.
tainty about future threats. Past elicit anxiety about one’s very exis- over human history, indicating that it Another election that has a lesson
threats logged in our memories and tence and the meaning of one’s life. has an important evolutionary role. to teach us is 1980. The incumbent,
unconscious can also influence our That is called existential anxiety.8 Simply put, the evolutionary advan- Jimmy Carter, was defeated in part
view of upcoming risk. As such, anx- Individuals who are more intoler- tage of anxiety could be that it leads because the economy was awful,
iety is a natural emotion and vital for ant of uncertainty are especially vul- individuals to take fewer risks, seek which caused increased anxiety and
survival. In contrast to anxiety, fear is nerable to excessive anxiety.9 The safety, and focus on doing things unhappiness. In his infamous “crisis
an acute or phasic response to an im- brain correlate of this intolerance is well. On the other hand, anxiety can of confidence” speech, he tried to ad-
mediate and identifiable threat, as we an increase in striata volume, partic- limit the risk-taking that advances dress the nation’s concerns, but the
explained in a prior article for Psy- ularly in the putamen. One brain human adaptability. voting public concluded that President
chiatric Times titled “FDR, the Bene model of subclinical and clinical In terms of evolutionary psycholo- Carter was in over his head. Similarly,
Gesserit, and the Psychiatry of Fear.”7 anxiety is the uncertainly and antici- gy, anxiety would help us survive as a the COVID-19 pandemic has adverse-
PSY1020__001_018-025_Cover.indd 18 9/30/20 9:06 AM

O CTO B ER 2020 PS YC H I ATRI C TI M E S 19
ly affected our economy, although it

remains to be seen if the electorate Table. Approaches for Alleviating Feelings of Election Anxiety
will hold the president accountable.
The concern about the economy  Monitor your anxiety level.  Take social media breaks.
also brings 1932 into the picture. High
unemployment levels contributed to  Set boundaries on how much  Try to build some
Herbert Hoover’s landslide defeat. attention you pay to politics. consensus with those who
Franklin Delano Roosevelt led the re-  Read diverse news sources. have differing opinions.
covery with federal work projects and  Control what you can control.
mobilization for World War II. In his  Practice values-based living, which
first inaugural address, Roosevelt told brings your everyday actions closer
Americans that that they had “nothing to your existential values.
to fear but fear itself.” He was effec-
tive because he at once calmed the good reason to think an individual is spread fears of voter suppression, sential for making presidential anxiety
nation’s nerves and tackled the under- incapable of serving in a public office. voter fraud, and delayed results. useful, rather than harmful for the
lying sources of its anxiety: poverty, The vice president can represent Post-election anxiety could escalate public, patients, and for ourselves.
unemployment, and hunger. other personal qualities that are im- even more than in 2000, when a con- Our Psychiatric Times polls indicate
For psychiatrists in particular, per- portant to the public. Joe Biden, Don- troversial Supreme Court decision that both we and our patients are quite
haps the most anxiety-provoking ald Trump, and Mike Pence are all ended the Bush-Gore race. worried, with the good news that
election was in 1964. Answering a older white males. In contrast, Biden about half of us are already trying to
poll conducted by FACT magazine on chose Kamala Harris as his running The role of psychiatry do something productive about it.
whether Barry Goldwater was men- mate. In picking a woman who is the At least going back to the time of The role of psychiatry in politics
tally fit to be president, about half of child of Indian and Jamaican immi- Plato, philosophers have tried to re- has been limited by the Goldwater
the replying psychiatrists provided grants, he may be trying to assure the duce the role of emotions such as anx- Rule against commenting on public
what Freud would call “wild analy- younger and more ethnically diverse iety in politics and promote rationality figures that we have not evaluated. As
sis.” Goldwater sued the magazine, parts of the electorate that he shares alone.1 Given the importance of anxi- a result, psychiatry has retreated to the
won his case, and psychiatrists were their concerns with racism, sexism, ety in our evolution, psychiatry should margins of the political arena. How
embarrassed. The result was the 1973 and other forms of discrimination. not be surprised at the limitations of might psychiatrists play a larger, more
Goldwater Rule, set by the American Looking back on this historical that approach. productive role in American public
Psychiatric Association. The rule survey, it appears that Americans re- Of course, undo anxiety about life? Psychiatrists could be involved in
barred psychiatrists from diagnosing ward politicians who are able to ac- safety and security leads to vulnera- routine mental health assessments of
or analyzing a public figure, an ad- knowledge their anxieties and put bility, a propensity to being manipu- any presidential candidate and annual-
monishment stirring anxiety and de- forth credible plans to eliminate the lated instead of educated. Recent ly for the president. Additionally, there
bate among psychiatrists in our sources of their fears. Politicians who polls indicate that such groups as is no prohibition against educating the
time.14 Goldwater lost the 1964 elec- appear to be overly anxious, or young adults, Blacks, and Latinos are public and our patients about the role
tion to Johnson in part because the blithely unconcerned, fare poorly. becoming increasingly anxious, like- of anxiety in politics. Psychiatrists
electorate feared he might overreact ly due to uncertainty about their fu- could help their fellow citizens hit the
to a perceived Russian threat and Potential interventions ture. Particular attention needs to be sweet spot of anxiety: enlightened par-
start a nuclear war. Although you will not find “election paid to the well-being of these groups ticipation, voting, realistic hope, and
In the 2016 election, our Psychiat- stress disorder” in DSM 5, it has been in terms of family and community improved mental well-being. In fact, it
ric Times poll found that two-thirds described.16 This “disorder” leads to psychological support, which in turn is psychiatry’s ethical responsibility to
of responders preferred Hillary Clin- all-or-nothing thinking and defense can make them more resilient. contribute what we can “to the im-
ton. We had a comment section then, mechanisms of blame, denial, and Charismatic leaders more con- provement of the community and the
and the discussion was passionate, avoidance. These reactions can lead to cerned with themselves and their betterment of public health.”20
suggesting some intense underlying cult-like, brainwashed adherence to a public image than with the public
anxiety in the mental health profes- one-sided perspective. Should you or good are particularly problematic. Concluding thoughts
sional community. your patients feel overwhelmed or With our 2-party system, political Psychiatric Times has featured a series
Although less attention is given to anxious, many of the traditional be- leadership can change suddenly, and looking at the psychiatric challenges
vice presidents and vice-presidential havioral approaches may prove to be the losing party is often afraid of what for the 2020s, and it now seems that
nominees, they can make a difference, helpful (Table). We need to be espe- will happen to them under the new politics and psychiatry will be one of
and their influence is not lost on voters cially cognizant of countertransfer- regime. Leadership for all is neces- them. This is one of the social aspects
or candidates. For instance, George ence, reactions where our own anxiety sary to reassure the losing side that it of psychiatry.21 There are 2 more elec-
McGovern initially added Thomas Ea- and political beliefs intrude into the does not need to panic or lash out. tions scheduled during this decade. Just
gleton as his vice president on the 1972 therapeutic arena. Anxiety is an essential emotion that like finding the right amount of anxiety,
democratic ticket. Upon learning that After the election, another infor- can help us assess and respond to future we need to find the right amount of po-
Eagleton had clinical depressive epi- mal disorder may emerge: a so-called risks to our safety and security, a basic litical engagement, not too much and
sodes, McGovern consulted with psy- post-election stress disorder. This human psychological need as Maslow not too little, in the 2020s.
chiatrists who apparently advised him phrase was first coined when Presi- has taught us.18 However, to use anxi-
that a recurrence of depression was dent Obama was elected as a result of ety successfully, people need to be able Dr Moffic is an award-winning psy-
possible and could endanger the coun- conflict and rising anxiety, especially to assess risks rationally. Although the chiatrist who has specialized in the
try.15 As a result, McGovern dropped around the issue of race.17 Therefore, future is unknowable, educated esti- cultural and ethical aspects of psychi-
him from the ticket. Interestingly, Ea- it was not surprising to see some mates can still be made—if there are atry. A prolific writer and speaker, he
gleton went on to be reelected to the post-election emotional fallout and accurate information and facts. One of received the one-time designation of
senate and achieved other career suc- backlash regarding the country’s first the psychiatric lessons from the Span- being a Hero of Public Psychiatry from
RRICE@STOCK.ADOBE.COM
cesses, and McGovern lost in a land- Black President. Did those reactions ish flu and the public panic that accom- the Assembly of the American
slide. McGovern may have been too last and influence the election of panied it was the need for the govern- Psychiatric Association in 2002. He
anxious about Eagleton’s depressive President Trump? ment to be honest and open.19 has recently been leading Tikkun
episodes, which may have cost him the Whatever the case, the period after Since psychiatry has expertise in Olam advocacy movements on cli-
seat. And, as we psychiatrists know, the 2020 election may be more anx- distinguishing fantasy from reality, as mate instability, burnout,
recurrence may be a risk, but it is not a ious still. There are already wide- well as managing anxiety, we are es- Islamophobia, and Anti-Semitism for
PSY1020__001_018-025_Cover.indd 19 9/30/20 9:06 AM

20 PSYCH I AT R I C T I M ES OC TOBE R 2020
www.psychi a t r i c t i me s. c o m
a better world. He serves on the ination and depression, even as their education and in anxiety: an integrated neurobiological and psycholog- com/us/blog/anger-in-the-age-entitlement/201604/
incomes rise. The Conversation. July 21, 2020. ical perspective. Nat Rev Neurosci. 2013;14(7):488-501. do-you-suffer-election-stress-disorder
Editorial Board of Psychiatric Times.
5. Assari S. Interaction between race and gender on 11. Lykken DT. A study of anxiety in the sociopathic 17. Stosny S: Post election stress disorder. Psychology To-
implicit racial bias against blacks. Intern J Epidemio- personality. J Abnorm Psychol. 1957;55(1):6-10. day. November 4, 2008. Accessed September 11, 2020.
REFERENCES logic Research. 2018;5(2):43-49. 12. Lebrecht N. Genius & Anxiety: How Jews Changed https://www.psychologytoday.com/us/blog/do-the-right-
1. Albertson B. Anxious Politics: Democratic Citizenship in 6. Lerer L, Plott E, Gamio L. How Americans feel the World, 1847-1947. Scribner; 2019. thing/201702/post-election-stress-disorder-is-it-thing
a Threatening World. Cambridge University Press; 2015. about the country right now: Anxious. Hopeful. New 13. Dickinson MJ, Fava EJ. Anxiety and depression may 18. Maslow A. Toward a Psychology of Being. Sub-
2. Bethune, S. Americans are stressed about the presi- York Times. June 27, 2020. have an evolutionary role as negative reinforcers, encourag- lime Books, 2014.
dential election. Monitor on Psychology, 51(1). January 7. Moffic HS. FDR, the Bene Gesserit, and the Psychi- ing socialization. Medical Hypotheses. 2006;66(6):796-800. 19. Barry JM. What the 1918 flu pandemic teaches
1, 2020. Accessed September 11, 2020. http://www. atry of Fear. Psychiatric Times. March 31, 2020. 14. The Dangerous Case of Donald Trump: 37 Psychi- us. Yesterday’s lessons inform today’s prepared-
apa.org/monitor/2020/01/news-stressed-election https://www.psychiatrictimes.com/view/fdr-be- atrists and Mental Health Experts Assess a President. ness. MLO Med Lab Obs. 2006;38(9):26-28.
3. Czeisler MÉ, Lane RI, Petrosky E, et al. Mental ne-gesserit-and-psychiatry-fear. Lee B, ed. Thomas Dunne Books; 2019. 20. The Principles of Medical Ethics, With Annotations
Health, Substance Use, and Suicidal Ideation During 8. Yalom I. Existential Psychotherapy. Basic Books; 1980. 15. McGovern G. Grassroots: The Autobiography of Especially Applicable to Psychiatry. American Psychi-
the COVID-19 Pandemic - United States, June 24-30, 9. Kim MJ, Shin J, Taylor JM, Mattek AM, Chavez SJ, George McGovern. Random House; 1977. atric Association Publishing, 2013 Edition.
2020. MMWR Morb Mortal Wkly Rep. 2020;69(32): Whalen PJ. Intolerance of uncertainty predicts in- 16. Stosny S. Do you suffer from election stress dis- 21. Moffic HS. Should the 2020s be the psychiatric
1049-1057. Published 2020 Aug 14. creased striatal volume. Emotion. 2017;17(6):895-899. order? Psychology Today. April 15, 2016. Accessed decade of the social? A debate. World Social Psychi-
4. Assari S, Curry TJ. Black men face higher discrim- 10. Grupe DW, Nitschke JB. Uncertainty and anticipation September 11, 2020. https://www.psychologytoday. atry. 2020;2(2):156-158. ❒
Treatment they can wear
The first and only FDA-approved transdermal

system for adults with SCHIZOPHRENIA
SECUADO is a once-daily patch that provides you with 3 medication strengths for dosing
flexibility, and offers your patients with schizophrenia a different treatment option.
Learn about transdermal at SecuadoHCP.com
INDICATION
SECUADO (asenapine) transdermal system is indicated for the treatment of adults with schizophrenia.
®
IMPORTANT SAFETY INFORMATION
WARNING:
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased
risk of death. SECUADO is not approved for the treatment of patients with dementia-related psychosis
Contraindications: Severe hepatic impairment (Child-Pugh C) or a history of hypersensitivity reactions to asenapine

or any components of this formulation.
Cerebrovascular Adverse Events, Including Stroke: Elderly subjects with dementia had a higher incidence of stroke
(including fatal stroke) and transient ischemic attack in clinical trials with antipsychotic drugs. SECUADO is not
approved for the treatment of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with
antipsychotics. NMS can cause hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic
instability. If NMS is suspected, immediately discontinue SECUADO and provide intensive symptomatic treatment
and monitoring.
Please see additional Important Safety Information and Brief Summary of full
Prescribing Information, including BOXED WARNING, on following pages.
PSY1020__001_018-025_Cover.indd 20 9/30/20 10:47 AM

O CTO B ER 2020 PS YC H I ATRI C TI M E S 21
Mental Health Pandemic

Continued from Cover
Figure. Mental Health Symptoms During COVID
During late June, 40% of US adults reported

struggling with mental health or substance use*
without an established diagnosis.1 So, spected mental health professionals
yes, many folks are indeed suffering. have taken to using this linguistically ANXIETY/DEPRESSION SYMPTOMS 31%
All this has led many news outlets awkward term. (Ironically, mental TRAUMA/STRESSOR-RELATED DISORDER SYMPTOMS 26%
and even some psychiatrists to de- health pandemic understood in epide- STARTED OR INCREASED SUBSTANCE USE 13%
clare a “mental health pandemic” or miological terms would mean some-
SERIOUSLY CONSIDERED SUICIDE† 11%
“secondary pandemic” amidst the al- thing like “a worldwide outbreak of
ready devastating COVID-19 pan- mental health.”) While well-inten- *Based on a survey of US adults aged ≥18 years during June 24-30, 2020
demic.2 I found about 145,000 results, tioned, the casual and colloquial use †
In the 30 days prior to survey
searching the term mental health pan- of the term pandemic is not warranted
SOURCE: CDC.gov
demic on Google. Indeed, several rein this context.
ACTOR PORTRAYAL
For your adult

patients with
SCHIZOPHRENIA¹
Tardive Dyskinesia (TD): Risk of TD and the likelihood that it will become irreversible increases with the duration of
treatment and the cumulative dose of antipsychotic drugs, including SECUADO. TD can develop after relatively brief
treatment periods, even at low doses, and may also occur after discontinuation of treatment. Prescribe SECUADO in
a manner most likely to reduce the risk of TD. If signs and symptoms of TD appear, drug discontinuation should
be considered.
Metabolic Changes: Atypical antipsychotic drugs, including SECUADO, have caused metabolic changes, including
the following:
• Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases associated with ketoacidosis, hyperosmolar
coma, or death, has been reported in patients treated with atypical antipsychotics. Hyperglycemia has been
reported in patients treated with sublingual asenapine. Assess fasting plasma glucose before or soon after initiation
of treatment, and monitor periodically during long-term treatment.
• Dyslipidemia: Atypical antipsychotics cause adverse alterations in lipids. Before or soon after initiation of
antipsychotic medication, obtain a baseline fasting lipid profile and monitor periodically during treatment.
• Weight Gain: Weight gain has been observed with atypical antipsychotics, including SECUADO. Monitor weight at
baseline and frequently thereafter.
Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, angioedema, hypotension, tachycardia,

dyspnea, wheezing, and rash have been reported in patients treated with asenapine, including SECUADO. In several
cases, these reactions occurred after the first dose.
IMAGE CREDIT
Orthostatic Hypotension, Syncope, and Other Hemodynamic Effects: Atypical antipsychotics cause orthostatic
hypotension and syncope. The risk is greatest during the initial dose titration and when increasing the dose. Monitor
orthostatic vital signs and patients who are vulnerable to hypotension. Use SECUADO cautiously with other drugs
that can cause hypotension, bradycardia, respiratory or central nervous system depression. Consider a dose reduction if
hypotension occurs.
PSY1020__001_018-025_Cover.indd 21 9/30/20 9:06 AM

Of course, I understand that the in- ported that bogus claim.3,4 And this is to a disease epidemic that has spread Upon careful, clinical evaluation,
tention underlying the term is to high- more than a semantic quibble. The use over several countries or continents, such self-reported symptoms may or
light a worldwide upsurge in mental or misuse of language can have powerful usually affecting a large number of may not turn out to be a clinically sig-
health issues and symptoms, which is effects on the public’s beliefs and percep- people.7 The critical term here is dis- nificant disease or mental illness. The
a valid concern. But problems often tions—witness the baneful effects of the ease, and the critical point is that CDC report itself notes this limitation
arise when we co-opt terms and apply “schizophrenogenic mother”5 or “chem- self-reported symptoms obtained from of its survey, stating “a diagnostic
them to psychiatry. For example, the ical imbalance” tropes.6 a screening survey do not establish the evaluation for anxiety disorder or de-
same casual misuse of epidemiologi- Let us back up a bit and explore the presence of a psychiatric disease, ill- pressive disorder was not conducted.”1
cal terms has been commonly used in definitions of these terms. An epidemic ness, or disorder. Many people can ex- Consider the diagnosis of general-
the popular press for years when refer- refers to an increase, often sudden, in perience a new onset of—or an increase ized anxiety disorder (GAD). Accord-
ring to various “epidemics” of psychi- the number of cases of a disease above in—one or more symptoms of anxiety ing to the DSM-5, symptoms must be
atric illness in the United States—even what is normally expected in that pop- or depression, but not meet clinical cri- present for at least 6 months—so no
though no credible evidence ever sup- ulation in that area. A pandemic refers teria for a psychiatric disorder. one who responded to the CDC sur-
IMPORTANT SAFETY INFORMATION, Continued SEC

BRIEF
FULL P
Falls: SECUADO may cause somnolence, postural hypotension and motor or sensory instability, which may lead to
falls, and consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could W
exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for S
patients on long-term antipsychotic therapy. E
r
Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia, and agranulocytosis (including fatal INDIC
cases) have been reported with antipsychotics, including asenapine. Monitor complete blood count in patients with SECUA
pre-existing low white blood cell count (WBC) or absolute neutrophil count or history of drug-induced leukopenia
or neutropenia. Discontinue SECUADO at the first sign of a clinically significant decline in WBC and in severely CONTR
neutropenic patients. SECUA
• Seve
• A hi
QT Prolongation: Sublingual asenapine was associated with increases in QTc interval from 2 to 5 msec versus Rea
placebo. There were no reports of QT prolongation exceeding 500 msec for SECUADO and placebo. The use of tong
SECUADO should be avoided in patients with a history of cardiac arrhythmias and in circumstances that may
increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs WARN
that prolong the QTc interval. Increa
Elderl
Hyperprolactinemia: SECUADO can elevate prolactin levels and the elevation can persist during chronic of dea
atypic
administration. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased that s
bone density in both female and male subjects in dru
the ca
Seizures: Use SECUADO with caution in patients with a history of seizures or with conditions that lower the sudde
seizure threshold. patien
Potential for Cognitive and Motor Impairment: Somnolence was reported in patients treated with SECUADO. Cereb
In pla
Caution patients about operating hazardous machinery, including motor vehicles, until they are reasonably certain aripip
that SECUADO does not affect them adversely. stroke
Body Temperature Regulation: Use SECUADO with caution in patients who will experience conditions that increase Neuro
body temperature (strenuous exercise, extreme heat, dehydration and concomitant anticholinergics). A pote
been
Dysphagia: SECUADO should be used cautiously in patients at risk for aspiration. Esophageal dysmotility and hyper
may i
aspiration have been associated with antipsychotic drug use. NMS i
and m
External Heat: Avoid direct external heat sources while wearing SECUADO.
Tardiv
Application Site Reactions: During wear time or immediately after removal of SECUADO, local skin irritation may Tardiv
occur. Instruct patients to select a different patch application site each day to limit the occurrence of skin irritation. devel
amon
to dev
Adverse Reactions: Commonly observed adverse reactions (incidence ≥5% and at least twice the rate of placebo) is mo
were extrapyramidal disorder, application site reaction and weight gain. be res
drugs
Drug Interactions: Monitor blood pressure and adjust antihypertensive drugs when taken with SECUADO. Based appro
on clinical response, SECUADO dose reduction may be necessary when used with strong CYP1A2 inhibitors of trea
(fluvoxamine). Reduce paroxetine (CYP2D6 substrate and inhibitor) dose by half when taken with SECUADO. contin
discon
the pr
Pregnancy: Studies have not been conducted with SECUADO in pregnant women. Advise patients to notify
their healthcare provider of a known or suspected pregnancy. The National Pregnancy Registry for Atypical Metab
Antipsychotics monitors pregnancy outcomes in women exposed to antipsychotics, including SECUADO, during Hyper
pregnancy. For information, contact 1-866-961-2388 or http://womensmentalhealth.org/clinical-and-research- Hyper
programs/pregnancyregistry/. has b
in pat
To report suspected Adverse Reactions, contact Noven at 800-455-8070 or FDA at 800-FDA-1088 or antips
Repor
www.fda.gov/medwatch. from
Please see brief summary of full prescribing information on following pages. Table
Schizo
Reference: 1. Secuado® (asenapine) transdermal system [prescribing information]. Miami, FL: Noven Therapeutics,
LLC; October 2019.
Cha
No
Hig
Bor
Hig
N* = N
In the
patien
Dyslip
Atypic
medic
SECUADO is a registered trademark of Hisamitsu Pharmaceutical Co., Inc. the pl
© 2020 Noven Therapeutics, LLC. All rights reserved.
For US audience only.
SDO-2124-16 7/20
Treatment they can wear
PSY1020__001_018-025_Cover.indd 22 9/30/20 9:06 AM

O ctob er 2020 PS YC H I ATRI C TI M E S 23
vey in June 2020 would have met that threshold—much less, that you have a demic. I suspect—although I cannot reaction to life’s “slings and arrows”
criterion if their anxiety symptoms mental disorder. The difference be- prove—that many of the respondents and its manifold, painful losses.10
began, say, in March 2020. Further- tween symptoms and disorder is not were reporting symptoms reflecting In my experience, only a careful clin-
more, DSM-5 criteria for nearly all merely semantic. A formal, clinical understandable demoralization and ical evaluation could distinguish pro-
the major disorders require that the diagnosis of a mental disorder has grief—and these are not mental disor- found demoralization and grief from
person demonstrates “clinically sig- wholly different implications—medi- ders. On the contrary, as psychologist major depressive illness among the
nificant distress or impairment in so- cal, legal, and psychological—than John F. Schumaker9 has elegantly put CDC survey respondents. Screening in-
cial, occupational, or other important those associated with, say, a normal or it, demoralization is “an overarching struments like the 4-item Patient Health
areas of functioning.”8 adaptive response to the stress and psycho-spiritual crisis in which vic- Questionnaire (PHQ-4)—used in the
Experiencing an uptick in some strain of the COVID-19 pandemic. tims feel generally disoriented and CDC survey—simply cannot do the job.
symptoms of anxiety or depression The nebulous term depression may unable to locate meaning, purpose, or None of this is to minimize the
does not necessarily mean that you be misleading when considering ma- sources of need fulfilment.” And mental health challenges posed by the
have reached that distress-impairment ny emotional reactions to the pan- grief, of course, is a normal, adaptive COVID-19 pandemic. Individuals
SECUADO® (asenapine) transdermal system Table 2: Changes in Lipids in Adult Patients in the 6-Week, Placebo-Controlled, Fixed Dose
Schizophrenia Trial
Falls
SECUADO may cause somnolence, postural hypotension, motor and sensory instability, which may
discomfort, pain, ede
adult trial, application
BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION. SEE PACKAGE INSERT FOR lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, hours and in 13.7% (2
SECUADO or medications that could exacerbate these effects, complete fall risk assessments when initiating
FULL PRESCRIBING INFORMATION placebo patients. The
Placebo 3.8 mg/24 7.6 mg/24 antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy. 9.3% (19/204) of patie
WARNING: INCREASED MORTALITY IN ELDERY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS hours hours mg/24 hours compar
See full prescribing information for complete boxed warning. Leukopenia, Neutropenia, and Agranulocytosis was pruritus, which w
Eldery patients with dementia-realted psychosis treated with antipsychotic drugs are at an increased Mean Change from Baseline In clinical trials and/or postmarketing experience, events of leukopenia and neutropenia have been 3.9% (8/204) of patie
risk of death. SECUADO is not approved for the treatment of patients with dementia-related psychosis. reported temporally related to antipsychotic agents, including asenapine. Agranulocytosis (including One patient develope
Total Cholesterol (mg/dL) (N*) 0.7 (174) 5.1 (174) 4.5 (172) fatal cases) has also been reported with other agents in the class. Possible risk factors for leukopenia/ sites that persisted fo
INDICATIONS AND USAGE neutropenia include pre-existing low white blood cell count (WBC) or absolute neutrophil count (ANC) reactions occurred m
SECUADO is an atypical antipsychotic indicated for the treatment of adults with schizophrenia. LDL (mg/dL) (N*) 1.6 (172) 1.4 (170) 4.2 (169) and history of drug-induced leukopenia/neutropenia. In patients with pre-existing low WBC or ANC or Inform patients of the
history of drug-induced leukopenia or neutropenia, perform a complete blood count (CBC) frequently if applied for a longer
HDL(mg/dL) (N*) -0.8 (174) 0.2 (174) -0.7 (172) during the first few months of therapy. In such patients, consider discontinuation of SECUADO at the patients to select a di
CONTRAINDICATIONS
SECUADO is contraindicated in patients with: first sign of a clinically significant decline in WBC in the absence of other causative factors. Monitor
Fasting triglycerides (mg/dL) (N*) -2.6 (174) 17.3 (174) 6.7 (172) patients with clinically significant neutropenia for fever or other symptoms or signs of infection ADVERSE REACTIONS
• Severe hepatic impairment (Child-Pugh C).
• A history of hypersensitivity reactions to asenapine or any components of the transdermal system. and treat promptly if such symptoms or signs occur. Discontinue SECUADO in patients with severe Clinical Trials Experie
Proportion of Patients with Shifts from Baseline to Endpoint (n/N*) neutropenia (absolute neutrophil count <1000/mm3) and follow their WBC until recovery.
Reactions with asenapine have included anaphylaxis, angioedema, hypotension, tachycardia, swollen Because clinical trials
tongue, dyspnea, wheezing, and rash. Total Cholesterol in the clinical trials of
1.0% (2/197) 2.6% (5/196) 1.0% (2/199) QT Prolongation and may not reflect t
Normal to High <200 to ≥ 240 mg/dL (n/N*) The effects of sublingual asenapine on the QT/QTc interval were evaluated in a dedicated adult
WARNINGS AND PRECAUTIONS The safety of SECUAD
Increased Mortality in Elderly Patients with Dementia-Related Psychosis LDL Normal to High <100 to ≥ 160 mg/dL (n/N*) 0.5% (1/195) 1.0% (2/194) 0% (0/197) QT study. This trial involved sublingual asenapine doses of 5 mg, 10 mg, 15 mg, and 20 mg twice were exposed to SECU
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk daily, and placebo, and was conducted in 151 clinically stable patients with schizophrenia, with Adverse Reactions Le
of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking HDL Normal to Low ≥ 40 to <40 mg/dL (n/N*) 8.1% (16/197) 10.7% (21/196) 12.1% (24/199) electrocardiographic assessments throughout the dosing interval at baseline and steady-state. At A total of 4.9% (10/20
atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times these doses, sublingual asenapine was associated with increases in QTc interval ranging from 2 to 5 treated with SECUADO
Fasting Triglycerides msec compared to placebo. No patients treated with sublingual asenapine experienced QTc increases to adverse reactions i
that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death 1.1% (2/185) 7.0% (13/185) 3.2% (6/186)
in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although Normal to High <150 to ≥ 200 mg/dL (n/N*) ≥60 msec from baseline measurements, nor did any patient experience a QTc of ≥500 msec. In led to discontinuation
the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, the placebo-controlled trial, there were no reports of QT prolongations exceeding 500 msec for discontinuation in no
sudden death) or infectious (e.g., pneumonia) in nature. SECUADO is not approved for the treatment of N* = Number of patients who had assessments at both Baseline and Endpoint. SECUADO and placebo. There were no reports of Torsades de Pointes or any other adverse reactions treated with SECUADO
patients with dementia-related psychosis. associated with delayed ventricular repolarization with sublingual asenapine or with SECUADO. The Commonly Observed
In the placebo-controlled schizophrenia trial with SECUADO, the proportion of patients with total use of SECUADO should be avoided in combination with other drugs known to prolong QTc including The most common ad
cholesterol elevations ≥240 mg/dL (at Endpoint) was 10.7% for patients treated with SECUADO 3.8 mg/24 Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, patients with schizop
Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis hours and 13.6% for patients treated with SECUADO 7.6 mg/24 hours versus 10.2 % for placebo-treated
In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, sotalol), antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and antibiotics disorder, application
patients. The proportion of patients with elevations in triglycerides ≥200 mg/dL (at Endpoint) was 17.8% (e.g., gatifloxacin, moxifloxacin). SECUADO should also be avoided in patients with a history of cardiac Adverse Reactions Oc
aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal for SECUADO 3.8 mg/24 hours and 12.4% for SECUADO 7.6 mg/24 hours treated patients versus 10.3% for
stroke. SECUADO is not approved for the treatment of patients with dementia-related psychosis. arrhythmias and in other circumstances that may increase the risk of the occurrence of torsade de Adverse reactions ass
placebo-treated patients. pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, percent, and SECUADO
Neuroleptic Malignant Syndrome including bradycardia; hypokalemia or hypomagnesemia; and presence of congenital prolongation are shown in Table 5.
Weight Gain of the QT interval.
A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has Weight gain has been observed with atypical antipsychotic use, including SECUADO. Monitor weight at
been reported in association with administration of antipsychotic drugs. Clinical manifestations of NMS are Table 5: Adverse Rea
baseline and frequently thereafter. Data on mean changes in body weight and the proportion of subjects Hyperprolactinemia Greater Incidence Tha
hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability. Additional signs meeting a weight gain criterion
may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. If Like other drugs that antagonize dopamine D2 receptors, SECUADO can elevate prolactin levels, and
of ≥7% of body weight from the placebo-controlled schizophrenia trial are presented in Table 3. the elevation can persist during chronic administration. Galactorrhea, amenorrhea, gynecomastia, and
NMS is suspected, immediately discontinue SECUADO and provide intensive symptomatic treatment
and monitoring. impotence have been reported in patients receiving prolactin-elevating compounds. Long-standing System Organ
Table 3: Change in Body Weight in Adult Patients from Baseline in the 6-Week, Placebo-Controlled, Fixed hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in Preferred T
Dose Schizophrenia Trial both female and male subjects. In the SECUADO placebo-controlled trial, galactorrhea, amenorrhea,
Tardive Dyskinesia
Tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements may gynecomastia and impotence were not reported for patients treated with SECUADO or placebo. Gastrointestinal
SECUADO In sublingual asenapine adult pre-marketing clinical trials, the incidences of adverse events related to
develop in patients treated with antipsychotic drugs, including SECUADO. The risk appears to be highest Placebo
among the elderly, especially elderly women, but it is not possible to predict which patients are likely abnormal prolactin levels were 0.4% versus 0% for placebo. Tissue culture experiments indicate that Constipation
3.8 mg/24 hours 7.6 mg/24 hours approximately one-third of human breast cancers are prolactin-dependent in vitro, a factor of potential
to develop the syndrome. Given these considerations, SECUADO should be prescribed in a manner that
is most likely to reduce the risk of tardive dyskinesia. Chronic antipsychotic treatment should generally importance if the prescription of these drugs is considered in a patient with previously-detected breast
Mean Change from Baseline (kg) (N*) 0.62 (167) 2.10 (168) 2.02 (164) cancer. Neither clinical studies nor epidemiologic studies conducted to date have shown an association Dyspepsia
be reserved for patients: (1) who suffer from a chronic illness that is known to respond to antipsychotic
drugs; and (2) for whom alternative, effective, but potentially less harmful treatments are not available or between chronic administration of this class of drugs and tumorigenesis in humans, but the available
Proportion of Patients with a ≥7% Increase in Body Weight evidence is too limited to be conclusive. Diarrhea
appropriate. In patients who do require chronic treatment, use the lowest dose and the shortest duration
of treatment producing a satisfactory clinical response should be sought. Periodically reassess the need for % with ≥7% increase in body
3.9% (8/203) 18.3% (37/202) 14.3% (29/203) Seizures General Disorder
continued treatment. If signs and symptoms of tardive dyskinesia appear in a patient on SECUADO, drug weight (n/N*)
discontinuation should be considered. However, some patients may require treatment with SECUADO despite In the SECUADO placebo-controlled trial, there were no reports of seizures in adult patients treated with
the presence of the syndrome. N* = Number of subjects with data at Endpoint. doses of 3.8 mg/24 hours and 7.6 mg/24 hours of SECUADO. During adult pre-marketing clinical trials Application si
with sublingual asenapine, including long-term trials without comparison to placebo, seizures were
In the sublingual asenapine 52-week, double-blind, comparator-controlled adult trial that included reported in 0.3% (5/1953) of patients treated with sublingual asenapine. As with other antipsychotic
Metabolic Changes primarily patients with schizophrenia, the mean weight gain from baseline was 0.9 kg. The proportion of Investigations
Hyperglycemia and Diabetes Mellitus drugs, SECUADO should be used with caution in patients with a history of seizures or with conditions
patients with a ≥7% increase in body weight (at Endpoint) was 14.7%. Table 4 provides the mean weight that potentially lower the seizure threshold. Conditions that lower the seizure threshold may be more
Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, change from baseline and the proportion of patients with a weight gain of ≥7% categorized by Body Mass Blood glucose
has been reported in patients treated with atypical antipsychotics. There have been reports of hyperglycemia prevalent in patients 65 years or older.
Index (BMI) at baseline.
in patients treated with sublingual asenapine. Assess fasting plasma glucose before or soon after initiation of
antipsychotic medication, and monitor periodically during long-term treatment. Potential for Cognitive and Motor Impairment Weight increa
Table 4: Weight Change Results Categorized by BMI at Baseline: Comparator-Controlled 52-Week Study SECUADO, like other antipsychotics, has the potential to impair judgment, thinking or motor skills.
Reports of hyperglycemia in patients treated with SECUADO were <1% in the placebo-controlled trial. Data with Sublingual Asenapine in Adults with Schizophrenia Hepatic enzym
from the placebo-controlled schizophrenia trial are presented in Table 1. Patients should be cautioned about operating hazardous machinery, including motor vehicles, until
they are reasonably certain that SECUADO therapy does not affect them adversely. Somnolence increased*
BMI 23 - ≤27 was reported in patients treated with SECUADO. In the short-term, fixed-dose, placebo-controlled
Table 1: Changes in Fasting Glucose in Adult Patients in the 6-Week, Placebo-Controlled, Fixed Dose BMI <23 Sublingual BMI >27 Sublingual Infections and In
Schizophrenia Trial Sublingual Asenapine schizophrenia adult trial, somnolence was reported in 4.4% (9/204) of patients on SECUADO 3.8 mg/24
Asenapine N=295 Asenapine N=302 hours and in 3.4% (7/204) of patients on SECUADO 7.6 mg/24 hours compared to 1.5% (3/206) of placebo
N=290
SECUADO patients. There were no reports of somnolence that led to discontinuation in the placebo-controlled Nasopharyng
Placebo Mean change from Baseline (kg) 1.7 1 0 trial. During adult pre-marketing clinical trials with sublingual asenapine, including long-term trials
3.8 mg/24 hours 7.6 mg/24 hours without comparison to placebo, somnolence was reported in 18% (358/1953) of patients treated with Upper respira
% with ≥7% increase in sublingual asenapine. infection
22% 13% 9% Metabolism and
Mean Change from Baseline in Fasting Glucose at Endpoint body weight
Body Temperature Regulation Disorders
Change from Baseline (mg/dL) (N*) 0.03 (174) 3.28 (174) 3.72 (172) Hypersensitivity Reactions Atypical antipsychotics may disrupt the body’s ability to reduce core body temperature.
Hypersensitivity reactions have been observed in patients treated with asenapine, including SECUADO. Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may Increased app
Proportion of Patients with Shifts from Baseline to Endpoint In several cases, these reactions occurred after the first dose. These hypersensitivity reactions included: contribute to an elevation in core body temperature; use SECUADO with caution in patients who may
anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash. experience these conditions. Nervous System
Normal to
0% (0/198) 3.1 % (6/196) 3.0 % (6/199)
High <100 to ≥ 126 mg/dL (n/N*) Orthostatic Hypotension, Syncope, and Other Hemoodynamic Effects Dysphagia Headache
Borderline to Atypical antipsychotics cause orthostatic hypotension and syncope. Generally, the risk is greatest during Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. There
2.0% (4/198) 1.0% (2/196) 1.0% (2/199) initial dose titration and when increasing the dose. In the placebo-controlled trial, orthostatic hypotension were no reports of dysphagia with SECUADO; however, dysphagia has been reported with sublingual Extrapyramid
High ≥ 100 and <126 to ≥ 126 mg/dL (n/N*)
was reported in 1.5% (3/204) of patients treated with SECUADO 3.8 mg/24 hours and 0% (0/204) of asenapine. SECUADO and other antipsychotic drugs should be used cautiously in patients at risk for symptoms*
N* = Number of patients who had assessments at both Baseline and Endpoint. patients treated with SECUADO 7.6 mg/24 hours, compared to <1% (1/206) of patients treated with placebo. aspiration.
There were no reports of syncope for both doses of SECUADO in the placebo-controlled trial. During adult Akathisia
In the sublingual asenapine 52-week, double-blind, comparator-controlled trial that included primarily pre-marketing clinical trials with sublingual asenapine, including long-term trials without comparison to External Heat
patients with schizophrenia, the mean increase from baseline of fasting glucose was 2.4 mg/dL. placebo, syncope was reported in 0.6% (11/1953) of patients treated with sublingual asenapine. Orthostatic When heat is applied to SECUADO after application, both the rate and extent of absorption are Somnolence*
Dyslipidemia vital signs should be monitored in patients who are vulnerable to hypotension (elderly patients, patients increased. After application of a heating pad, asenapine exposure (partial AUC0-8) was about 3.9 times
Atypical antipsychotics cause adverse alterations in lipids. Before or soon after initiation of antipsychotic with dehydration, hypovolemia, concomitant treatment with antihypertensive medications), patients with greater than without heating pad application. Advise patients to avoid exposing SECUADO to direct Dystonia
medication, obtain a fasting lipid profile at baseline and monitor periodically during treatment. Data from known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure, or external heat sources such as hair dryers, heating pads, electric blankets, heated water beds, etc., while
the placebo-controlled schizophrenia trial presented in Table 2. conduction abnormalities), and patients with cerebrovascular disease. SECUADO should be used cautiously wearing SECUADO. Vascular Disorde
when treating patients who receive treatment with other drugs that can induce hypotension, bradycardia,
respiratory or central nervous system depression. Monitoring of orthostatic vital signs should be considered Application Site Reactions
in all such patients, and a dose reduction should be considered if hypotension occurs. Local skin reactions, such as irritation, were reported with SECUADO. During wear time or immediately Hypertension
after removal of SECUADO, the skin at the site of application may develop erythema, pruritus, papules,
PSY1020__001_018-025_Cover.indd 23 9/30/20 9:06 AM

with established psychiatric diagnoses must also carefully monitor the long- undeserving of insurance coverage COVID-19 pandemic, nor should it
(eg, posttraumatic stress disorder, term psychological effects the pan- for, say, telemedicine counseling. We diminish our efforts at comforting
schizophrenia, or bipolar disorder) may demic may have on children and ado- know, for example, that subclinical and supporting them.
be experiencing serious, pandem- lescents.12 Finally, we must remain depression—ie, falling just short of
ic-related exacerbation of their ill- vigilant regarding the enormous phys- full DSM criteria for major depres- Dr Pies is professor emeritus of psy-
ness, and they may require immediate ical and emotional toll the pandemic is sion—can nevertheless be a disabling chiatry and lecturer on bioethics and
treatment or refinement of their cur- taking on our physicians, nurses, and condition that needs treatment, and humanities, SUNY Upstate Medical
rent treatment. There is also strong, other frontline health care workers.13 may respond to psychotherapy.14 University; clinical professor of psychi-
emerging evidence that COVID-19 And, let me clarify: the mere fact So, no—the term, mental health atry, Tufts University School of
may lead to serious and enduring neu- that someone may not meet full pandemic is not really helpful or ac- Medicine; and editor in chief emeritus
rological complications.11 Care and DSM-5 criteria for a mental disorder curate. But that observation does not of Psychiatric Times®.
treatment of these seriously affected does not mean that the person is un- negate the distress and loneliness of
individuals should be our priority. We worthy of professional attention, or so many who are enduring the Acknowledgments — I wish to thank
Table 2: Changes in Lipids in Adult Patients in the 6-Week, Placebo-Controlled, Fixed Dose Falls discomfort, pain, edema, or irritation. In the short-term, fixed-dose, placebo-controlled schizophrenia *Th
Schizophrenia Trial SECUADO may cause somnolence, postural hypotension, motor and sensory instability, which may adult trial, application site reactions were reported in 15.2% (31/204) of patients on SECUADO 3.8 mg/24 disc
lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, hours and in 13.7% (28/204) of patients on SECUADO 7.6 mg/24 hours compared to 3.9% (8/206) of and
SECUADO or medications that could exacerbate these effects, complete fall risk assessments when initiating placebo patients. The most common application site reaction was erythema, which was reported in hem
Placebo 3.8 mg/24 7.6 mg/24 antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy. 9.3% (19/204) of patients on SECUADO 3.8 mg/24 hours and in 9.8% (20/204) of patients on SECUADO 7.6 Hep
D PSYCHOSIS hours hours mg/24 hours compared to 1.5% (3/206) of placebo patients. Another common application site reaction am
Leukopenia, Neutropenia, and Agranulocytosis was pruritus, which was reported in 4.9% (10/204) of patients on SECUADO 3.8 mg/24 hours and in incl
rugs are at an increased Mean Change from Baseline In clinical trials and/or postmarketing experience, events of leukopenia and neutropenia have been 3.9% (8/204) of patients on SECUADO 7.6 mg/24 hours compared to 1.9% (4/206) of placebo patients. mu
mentia-related psychosis. reported temporally related to antipsychotic agents, including asenapine. Agranulocytosis (including One patient developed application site discoloration (hyperpigmentation) at multiple application incl
Total Cholesterol (mg/dL) (N*) 0.7 (174) 5.1 (174) 4.5 (172) fatal cases) has also been reported with other agents in the class. Possible risk factors for leukopenia/ sites that persisted for at least several weeks after discontinuing SECUADO treatment. Application site Dos
neutropenia include pre-existing low white blood cell count (WBC) or absolute neutrophil count (ANC) reactions occurred more frequently in Black or African American patients compared to Caucasians. extr
zophrenia. LDL (mg/dL) (N*) 1.6 (172) 1.4 (170) 4.2 (169) and history of drug-induced leukopenia/neutropenia. In patients with pre-existing low WBC or ANC or Inform patients of these potential reactions and that increased skin irritation may occur with SECUADO Dys
history of drug-induced leukopenia or neutropenia, perform a complete blood count (CBC) frequently if applied for a longer period than instructed or if the same application site is used repeatedly. Instruct Sym
HDL(mg/dL) (N*) -0.8 (174) 0.2 (174) -0.7 (172) during the first few months of therapy. In such patients, consider discontinuation of SECUADO at the patients to select a different application site each day to minimize skin reactions. dur
first sign of a clinically significant decline in WBC in the absence of other causative factors. Monitor pro
Fasting triglycerides (mg/dL) (N*) -2.6 (174) 17.3 (174) 6.7 (172) patients with clinically significant neutropenia for fever or other symptoms or signs of infection ADVERSE REACTIONS ton
nsdermal system. and treat promptly if such symptoms or signs occur. Discontinue SECUADO in patients with severe Clinical Trials Experience wit
Proportion of Patients with Shifts from Baseline to Endpoint (n/N*) neutropenia (absolute neutrophil count <1000/mm3) and follow their WBC until recovery.
tachycardia, swollen Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed is o
Total Cholesterol in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug xtra
1.0% (2/197) 2.6% (5/196) 1.0% (2/199) QT Prolongation and may not reflect the rates observed in practice. In t
Normal to High <200 to ≥ 240 mg/dL (n/N*) The effects of sublingual asenapine on the QT/QTc interval were evaluated in a dedicated adult The safety of SECUADO was evaluated in a total of 315 adult patients diagnosed with schizophrenia who Ang
LDL Normal to High <100 to ≥ 160 mg/dL (n/N*) 0.5% (1/195) 1.0% (2/194) 0% (0/197) QT study. This trial involved sublingual asenapine doses of 5 mg, 10 mg, 15 mg, and 20 mg twice were exposed to SECUADO for up to 6 weeks in a placebo-controlled trial. Ass
re at an increased risk daily, and placebo, and was conducted in 151 clinically stable patients with schizophrenia, with Adverse Reactions Leading to Discontinuation of Treatment 3.8
ely in patients taking HDL Normal to Low ≥ 40 to <40 mg/dL (n/N*) 8.1% (16/197) 10.7% (21/196) 12.1% (24/199) electrocardiographic assessments throughout the dosing interval at baseline and steady-state. At A total of 4.9% (10/204) patients treated with SECUADO 3.8 mg/24 hours, 7.8% (16/204) patients the
between 1.6 to 1.7 times these doses, sublingual asenapine was associated with increases in QTc interval ranging from 2 to 5 treated with SECUADO 7.6 mg/24 hours, and 6.8% (14/206) patients on placebo discontinued due eve
Fasting Triglycerides msec compared to placebo. No patients treated with sublingual asenapine experienced QTc increases to adverse reactions in the placebo-controlled trial. The adverse reaction that most commonly 12.8
d trial, the rate of death 1.1% (2/185) 7.0% (13/185) 3.2% (6/186)
lacebo group. Although Normal to High <150 to ≥ 200 mg/dL (n/N*) ≥60 msec from baseline measurements, nor did any patient experience a QTc of ≥500 msec. In led to discontinuation among SECUADO-treated patients in this trial was akathisia, which led to the
scular (e.g., heart failure, the placebo-controlled trial, there were no reports of QT prolongations exceeding 500 msec for discontinuation in no (0/204) patients treated with SECUADO 3.8 mg/24 hours, 1.5% (3/204) patients pat
or the treatment of N* = Number of patients who had assessments at both Baseline and Endpoint. SECUADO and placebo. There were no reports of Torsades de Pointes or any other adverse reactions treated with SECUADO 7.6 mg/24 hours, and 0.5% (1/206) patients on placebo. Lab
associated with delayed ventricular repolarization with sublingual asenapine or with SECUADO. The Commonly Observed Adverse Reactions Tran
In the placebo-controlled schizophrenia trial with SECUADO, the proportion of patients with total use of SECUADO should be avoided in combination with other drugs known to prolong QTc including The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in adult trea
cholesterol elevations ≥240 mg/dL (at Endpoint) was 10.7% for patients treated with SECUADO 3.8 mg/24 Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, patients with schizophrenia treated with SECUADO in the placebo-controlled trial were extrapyramidal for
entia-Related Psychosis hours and 13.6% for patients treated with SECUADO 7.6 mg/24 hours versus 10.2 % for placebo-treated
to risperidone, sotalol), antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and antibiotics disorder, application site reaction, and weight gain. 1.1 u
patients. The proportion of patients with elevations in triglycerides ≥200 mg/dL (at Endpoint) was 17.8% (e.g., gatifloxacin, moxifloxacin). SECUADO should also be avoided in patients with a history of cardiac Adverse Reactions Occurring at an Incidence of 2% or More in SECUADO-Treated Patients nor
c attack, including fatal for SECUADO 3.8 mg/24 hours and 12.4% for SECUADO 7.6 mg/24 hours treated patients versus 10.3% for
d psychosis. arrhythmias and in other circumstances that may increase the risk of the occurrence of torsade de Adverse reactions associated with the use of SECUADO (incidence of ≥2%, rounded to the nearest hou
placebo-treated patients. pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, percent, and SECUADO incidence greater than placebo) that occurred during the placebo-controlled trial In a
including bradycardia; hypokalemia or hypomagnesemia; and presence of congenital prolongation are shown in Table 5. sch
Weight Gain of the QT interval. Pro
nt Syndrome (NMS) has Weight gain has been observed with atypical antipsychotic use, including SECUADO. Monitor weight at
nifestations of NMS are Table 5: Adverse Reactions in ≥ 2% of Patients in Any SECUADO Dose Group and Which Occurred at for
baseline and frequently thereafter. Data on mean changes in body weight and the proportion of subjects Hyperprolactinemia Greater Incidence Than in the Placebo Group in 6-Week Schizophrenia Trials plac
tability. Additional signs meeting a weight gain criterion
d acute renal failure. If Like other drugs that antagonize dopamine D2 receptors, SECUADO can elevate prolactin levels, and In a
of ≥7% of body weight from the placebo-controlled schizophrenia trial are presented in Table 3. the elevation can persist during chronic administration. Galactorrhea, amenorrhea, gynecomastia, and wit
matic treatment
impotence have been reported in patients receiving prolactin-elevating compounds. Long-standing System Organ Class/ Placebo SECUADO 3.8 mg/24 SECUADO 7.6 mg/24 hrs was
Table 3: Change in Body Weight in Adult Patients from Baseline in the 6-Week, Placebo-Controlled, Fixed hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in Preferred Term N=206 (%) hrs N=204 (%) N=204 (%) Crea
Dose Schizophrenia Trial both female and male subjects. In the SECUADO placebo-controlled trial, galactorrhea, amenorrhea, and
ovements may gynecomastia and impotence were not reported for patients treated with SECUADO or placebo. Gastrointestinal Disorders to 1
SECUADO In sublingual asenapine adult pre-marketing clinical trials, the incidences of adverse events related to find
ppears to be highest Placebo
patients are likely abnormal prolactin levels were 0.4% versus 0% for placebo. Tissue culture experiments indicate that Constipation 4 5 4 Oth
3.8 mg/24 hours 7.6 mg/24 hours approximately one-third of human breast cancers are prolactin-dependent in vitro, a factor of potential
d in a manner that Oth
nt should generally importance if the prescription of these drugs is considered in a patient with previously-detected breast sch
Mean Change from Baseline (kg) (N*) 0.62 (167) 2.10 (168) 2.02 (164) cancer. Neither clinical studies nor epidemiologic studies conducted to date have shown an association Dyspepsia 1 1 3
nd to antipsychotic rea
nts are not available or between chronic administration of this class of drugs and tumorigenesis in humans, but the available in t
Proportion of Patients with a ≥7% Increase in Body Weight evidence is too limited to be conclusive. Diarrhea 1 3 1
the shortest duration Gas
y reassess the need for % with ≥7% increase in body Gen
3.9% (8/203) 18.3% (37/202) 14.3% (29/203) Seizures General Disorders Mus
nt on SECUADO, drug weight (n/N*)
ent with SECUADO despite In the SECUADO placebo-controlled trial, there were no reports of seizures in adult patients treated with Oth
N* = Number of subjects with data at Endpoint. doses of 3.8 mg/24 hours and 7.6 mg/24 hours of SECUADO. During adult pre-marketing clinical trials Application site reactions* 4 15 14 Foll
with sublingual asenapine, including long-term trials without comparison to placebo, seizures were ase
In the sublingual asenapine 52-week, double-blind, comparator-controlled adult trial that included reported in 0.3% (5/1953) of patients treated with sublingual asenapine. As with other antipsychotic
primarily patients with schizophrenia, the mean weight gain from baseline was 0.9 kg. The proportion of pat
drugs, SECUADO should be used with caution in patients with a history of seizures or with conditions Investigations dru
patients with a ≥7% increase in body weight (at Endpoint) was 14.7%. Table 4 provides the mean weight that potentially lower the seizure threshold. Conditions that lower the seizure threshold may be more
molar coma or death, change from baseline and the proportion of patients with a weight gain of ≥7% categorized by Body Mass this
prevalent in patients 65 years or older. Blood glucose increased* 1 3 1 liste
reports of hyperglycemia Index (BMI) at baseline.
or soon after initiation of pat
Potential for Cognitive and Motor Impairment Weight increased 2 4 6 in t
Table 4: Weight Change Results Categorized by BMI at Baseline: Comparator-Controlled 52-Week Study SECUADO, like other antipsychotics, has the potential to impair judgment, thinking or motor skills.
o-controlled trial. Data with Sublingual Asenapine in Adults with Schizophrenia pat
Patients should be cautioned about operating hazardous machinery, including motor vehicles, until Hepatic enzyme Blo
0 2 2
they are reasonably certain that SECUADO therapy does not affect them adversely. Somnolence increased* Card
BMI 23 - ≤27 was reported in patients treated with SECUADO. In the short-term, fixed-dose, placebo-controlled Eye
olled, Fixed Dose BMI <23 Sublingual BMI >27 Sublingual Infections and Infestations
Sublingual Asenapine schizophrenia adult trial, somnolence was reported in 4.4% (9/204) of patients on SECUADO 3.8 mg/24 Gas
Asenapine N=295 Asenapine N=302 hours and in 3.4% (7/204) of patients on SECUADO 7.6 mg/24 hours compared to 1.5% (3/206) of placebo
N=290 Gen
SECUADO patients. There were no reports of somnolence that led to discontinuation in the placebo-controlled Nasopharyngitis 2 3 1 Inve
Mean change from Baseline (kg) 1.7 1 0 trial. During adult pre-marketing clinical trials with sublingual asenapine, including long-term trials Ner
urs 7.6 mg/24 hours without comparison to placebo, somnolence was reported in 18% (358/1953) of patients treated with Upper respiratory tract 2 3 1 Pos
% with ≥7% increase in sublingual asenapine. infection
22% 13% 9% Cho
int body weight Metabolism and Nutrition dys
Body Temperature Regulation Disorders DRU
3.72 (172) Hypersensitivity Reactions Atypical antipsychotics may disrupt the body’s ability to reduce core body temperature. CLIN
Hypersensitivity reactions have been observed in patients treated with asenapine, including SECUADO. Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may Increased appetite 0 3 1
Ant
point In several cases, these reactions occurred after the first dose. These hypersensitivity reactions included: contribute to an elevation in core body temperature; use SECUADO with caution in patients who may Alp
anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash. experience these conditions. Nervous System Disorders ma
) 3.0 % (6/199) ant
Orthostatic Hypotension, Syncope, and Other Hemoodynamic Effects Dysphagia Headache 6 9 9 Ase
Atypical antipsychotics cause orthostatic hypotension and syncope. Generally, the risk is greatest during Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. There Cm
1.0% (2/199) initial dose titration and when increasing the dose. In the placebo-controlled trial, orthostatic hypotension were no reports of dysphagia with SECUADO; however, dysphagia has been reported with sublingual Extrapyramidal 2 8 13 inh
was reported in 1.5% (3/204) of patients treated with SECUADO 3.8 mg/24 hours and 0% (0/204) of asenapine. SECUADO and other antipsychotic drugs should be used cautiously in patients at risk for symptoms* me
patients treated with SECUADO 7.6 mg/24 hours, compared to <1% (1/206) of patients treated with placebo. aspiration. par
There were no reports of syncope for both doses of SECUADO in the placebo-controlled trial. During adult Akathisia 2 4 4
USE
t included primarily pre-marketing clinical trials with sublingual asenapine, including long-term trials without comparison to External Heat Pre
s 2.4 mg/dL. placebo, syncope was reported in 0.6% (11/1953) of patients treated with sublingual asenapine. Orthostatic When heat is applied to SECUADO after application, both the rate and extent of absorption are Somnolence* 1 4 3 Pre
vital signs should be monitored in patients who are vulnerable to hypotension (elderly patients, patients increased. After application of a heating pad, asenapine exposure (partial AUC0-8) was about 3.9 times The
tion of antipsychotic with dehydration, hypovolemia, concomitant treatment with antihypertensive medications), patients with greater than without heating pad application. Advise patients to avoid exposing SECUADO to direct Dystonia 0 1 3 ant
g treatment. Data from known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure, or external heat sources such as hair dryers, heating pads, electric blankets, heated water beds, etc., while Reg
conduction abnormalities), and patients with cerebrovascular disease. SECUADO should be used cautiously wearing SECUADO. Vascular Disorders and
when treating patients who receive treatment with other drugs that can induce hypotension, bradycardia, Risk
respiratory or central nervous system depression. Monitoring of orthostatic vital signs should be considered Application Site Reactions Ne
in all such patients, and a dose reduction should be considered if hypotension occurs. Local skin reactions, such as irritation, were reported with SECUADO. During wear time or immediately Hypertension* 1 2 2
and
after removal of SECUADO, the skin at the site of application may develop erythema, pruritus, papules,
PSY1020__001_018-025_Cover.indd 24 9/30/20 9:06 AM

O ctob er 2020 PS YC H I ATRI C TI M E S 25
Awais Aftab, MD, for his helpful comments 3. Pies RW. The bogus “Epidemic” of mental illness in to Epidemiology. In: Principles of Epidemiology in 11. Heidt A. Dozens more cases of neurological prob-
on an earlier draft of this piece; and Ms the US. Psychiatric Times. June 18, 2015. Accessed Public Health Practice. October 2006; updated May lems in COVID-19 reported. Scientist. July 8, 2020.
August 21, 2020. https://www.psychiatrictimes.com/ 2012. Accessed August 21, 2020. https://www.cdc. Accessed August 21, 2020. https://www.the-scien-
Grace Huckins for prompting my consider- view/bogus-epidemic-mental-illness-us gov/csels/dsepd/ss1978/lesson1/section11.html tist.com/news-opinion/dozens-more-cases-report-
ation of this issue. 4. Pies RW. The astonishing non-epidemic continues. 8. American Psychiatric Association: Diagnostic & ed-of-neurological-problems-in-COVID-19-67717
PsychCentral. October 5, 2017. Accessed August 21, Statistical Manual of Mental Disorders, 5th ed. Amer- 12. Harris NB. Children will pay long-term stress-re-
REFERENCES 2020. https://pro.psychcentral.com/the-astonish- ican Psychiatric Publishing, Inc; 2013. lated costs of Covid-19 unless we follow the science.
1. Czeisler MÉ , Lane RI, Petrosky E, et al. Mental ing-non-epidemic-continues/ 9. Schumaker J. The demoralized mind. New Interna- Stat News. August 4, 2020. Accessed August 21,
health, substance use, and suicidal ideation during 5. Johnston J. The ghost of the schizophrenogenic tionalist. April 1, 2016. Accessed August 21, 2020. 2020. https://www.statnews.com/2020/08/04/chil-
the COVID-19 pandemic — United States, June 24– mother. Virtual Mentor. 2013;15(9):801-805. https://newint.org/columns/essays/2016/04/01/ dren-long-term-stress-related-costs-COVID-19/
30, 2020. MMWR Morb Mortal Wkly Rep. 6. Pies RW. Debunking the two chemical imbalance psycho-spiritual-crisis 13. Kelly M. The pandemic’s psychological toll: An
2020;69:1049-1057. myths, again. Psychiatric Times. August 2, 2019. Ac- 10. Pies RW, Geppert CMA. Clinical depression or “life emergency physician’s suicide. Ann Emerg Med. Ann
2. Gold J. Covid-19 might lead to a ‘Mental Health cessed August 21, 2020. https://www.psychiatric- sorrows”? Distinguishing between grief and depres- Emerg Med. 2020;76(3):A21-A24. [Epub ahead of print]
Pandemic.’ Forbes. August 6, 2020. Accessed August times.com/view/debunking-two-chemical-imbal- sion in pastoral care 1. Ministry. May 2015. Accessed 14. Cuijpers P, Koole SL, van Dijke A, et al. Psycho-
21, 2020. https://www.forbes.com/sites/jessica- ance-myths-again August 21, 2020. https://www.ministrymagazine. therapy for subclinical depression: meta-analysis. Br
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tal-health-pandemic/#333f0013706f
nia *The following terms were combined: Application site reactions includes application site dermatitis, are no available human data informing the drug-associated risk. The background risk of major birth defects
/24 discoloration, discomfort, dryness, edema, erythema, exfoliation, induration, irritation, pain, papules, pruritis, and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general
and reaction. Blood glucose increased includes blood glucose increased, blood insulin increased, glycosylated population of major birth defects is 2-4% and of miscarriage is 15- 20% of clinically recognized pregnancies.
n hemoglobin increased, hyperglycemia, Type 2 diabetes mellitus, diabetes mellitus, and hyperinsulinemia. Clinical Considerations
O 7.6 Hepatic enzyme increased includes hepatic enzyme increased, alanine aminotransferase increased, aspartate Fetal/Neonatal Adverse Reactions:
ion aminotransferase increased, and gamma-glutamyltransferase increased. Extrapyramidal symptoms Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence,
includes dyskinesia, dystonia, extrapyramidal disorder, parkinsonism, tardive dyskinesia, muscle spasm, and respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic
s. musculoskeletal stiffness. Somnolence includes somnolence, sedation, lethargy, and hypersomnia. Hypertension drugs during the third trimester of pregnancy. These symptoms have varied in severity. Some neonates
includes hypertension, blood pressure increased, diastolic hypertension, and hypertensive crisis. recovered within hours or days without specific treatment; others required prolonged hospitalization. Monitor
te Dose-Related Adverse Reactions: In the placebo-controlled schizophrenia trial, the incidence of an neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately.
extrapyramidal disorder and weight increased appear to be dose-related (see Table 5). Lactation
DO Dystonia: Lactation studies have not been conducted to assess the presence of asenapine in human milk, the effects of
uct Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals asenapine on the breastfed infant, or the effects of asenapine on milk production. Asenapine is excreted in rat
during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes milk. The development and health benefits of breastfeeding should be considered along with the mother’s
progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the clinical need for SECUADO and any potential adverse effects on the breastfed infant from SECUADO or from the
tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity underlying maternal condition.
with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia Pediatric Use
ed is observed in males and younger age groups. Safety and effectiveness of SECUADO in pediatric patients have not been established.
ug xtrapyramidal Symptoms: Geriatric Use
In the short-term, placebo-controlled schizophrenia adult trial, data were objectively collected on the Simpson The SECUADO placebo-controlled trial for the treatment of schizophrenia did not include sufficient numbers of
who Angus Rating Scale for extrapyramidal symptoms (EPS), the Barnes Akathisia Scale (for akathisia) and the patients aged 65 and over to determine whether or not they respond differently than younger patients.
Assessments of Involuntary Movement Scales (for dyskinesias). The mean change from baseline for the SECUADO Multiple factors that might increase the pharmacodynamic response to SECUADO, causing poorer tolerance
3.8 mg/24 hours or 7.6 mg/24 hours treated group was similar to placebo in each of the rating scale scores. In or orthostasis, could be present in elderly patients, and these patients should be monitored carefully. Based
the short-term, placebo-controlled schizophrenia adult trial, the incidence of reported extrapyramidal disorder on a pharmacokinetic study in elderly patients with sublingual asenapine, dosage adjustments are not
events, excluding events related to akathisia, was 7.8% for patients treated with SECUADO 3.8 mg/24 hours, recommended based on age alone.
12.8% for patients treated with SECUADO 7.6 mg/24 hours SECUADO and 2.4% for placebo-treated patients; and Elderly patients with dementia-related psychosis treated with SECUADO are at an increased risk of death
the incidence of akathisia-related events was 3.9% for patients treated with SECUADO 3.8 mg/24 hours, 4.4% for compared to placebo. SECUADO is not approved for the treatment of patients with dementia-related psychosis.
s patients treated with SECUADO 7.6 mg/24 hours and 2.4% for placebo-treated patients. Renal Impairment
Laboratory Test Abnormalities: No dosage adjustment for SECUADO is required on the basis of a patient’s renal function. The effect of renal
Transaminases: Transient elevations in serum transaminases (primarily ALT) were more common in SECUADO- function on the excretion of other metabolites and the effect of dialysis on the pharmacokinetics of asenapine
treated patients. The mean increase in ALT levels for SECUADO-treated patients was 6.0 units/L and 3.8 units/L has not been studied.
dal for the SECUADO 3.8 mg/24 hours and 7.6 mg/24 hours treated groups, respectively, compared to a decrease of Hepatic Impairment
1.1 units/L for placebo-treated patients. The proportion of patients with ALT elevations ≥3 times upper limit of SECUADO is contraindicated in patients with severe hepatic impairment (Child-Pugh C) because asenapine
normal (ULN) (at any time) was 1.6% and 3.1% for patients treated with SECUADO 3.8 mg/24 hours and 7.6 mg/24 exposure is 7-fold higher in subjects with severe hepatic impairment than the exposure observed in subjects
hours, respectively, and 0% for placebo-treated patients. with normal hepatic function. No dosage adjustment for SECUADO is required in patients with mild to moderate
trial In a 52-week, double-blind, comparator-controlled trial that included primarily adult patients with hepatic impairment (Child-Pugh A and B) because asenapine exposure is similar to that in subjects with normal
schizophrenia, the mean increase from baseline of ALT was 1.7 units/L for sublingual asenapine. hepatic function.
Prolactin: The proportion of patients with prolactin elevations ≥4 times ULN (at Endpoint) were 0.0% and 1.3% OVERDOSAGE
for patients treated with SECUADO 3.8 mg/24 hours and 7.6 mg/24 hours, respectively, as compared to 2.4% for Human Experience: In the placebo-controlled trial in adults for SECUADO, there were no reports of accidental
placebo-treated patients in the short-term placebo-controlled trial. or intentional acute overdosage of SECUADO. In adult clinical studies involving more than 3350 patients and/or
In a long-term (52-week), double-blind, comparator-controlled adult trial that included primarily patients healthy subjects for sublingual asenapine, accidental or intentional acute overdosage of sublingual asenapine
with schizophrenia, the mean decrease in prolactin from baseline for sublingual asenapine-treated patients was identified in 3 patients. Among these few reported cases of overdose, the highest estimated ingestion of
4 hrs was 26.9 ng/mL. sublingual asenapine was 400 mg. Reported adverse reactions at the highest dosage included agitation and
Creatine Kinase (CK): The proportion of adult patients with CK elevations ≥3 times ULN at any time were 1.6% confusion.
and 2.1% for patients treated with SECUADO 3.8 mg/24 hours and 7.6 mg/24 hours, respectively, as compared Management of Overdosage There is no specific antidote to SECUADO. The possibility of multiple drug
to 1.5% for placebo-treated patients in the short-term, placebo-controlled trial. The clinical relevance of this involvement should be considered. An electrocardiogram should be obtained and management of overdose
finding is unknown. should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and
Other Adverse Reactions Observed During the Premarketing Evaluation of SECUADO management of symptoms. Consult a Certified Poison Control Center at 1 800-222-1222 for up to date information
Other adverse reactions (<2% frequency) within the 6-week placebo-controlled trial in patients with on the management of overdosage. Hypotension and circulatory collapse should be treated with appropriate
schizophrenia are listed below. The reactions listed are those that could be of clinical importance, as well as measures, such as intravenous fluids and/or sympathomimetic agents (epinephrine and dopamine should not
reactions that are plausibly drug-related on pharmacologic or other grounds. Reactions that appear elsewhere be used, since beta stimulation may worsen hypotension in the setting of SECUADO-induced alpha blockade).
in the SECUADO label are not included. In case of severe extrapyramidal symptoms, anticholinergic medication should be administered. Close medical
Gastrointestinal disorders: vomiting, dry mouth supervision and monitoring should continue until the patient recovers.
General disorders and administration site conditions: asthenia
Musculoskeletal and connective tissue disorders: myalgia Please see full Prescribing Information. including BOXED WARNING at www.secuado.com
Other Adverse Reactions Reported in Clinical Trials with Sublingual Asenapine
Following is a list of MedDRA terms that reflect adverse reactions reported by patients treated with sublingual This brief summary is based on SECUADO Full Prescribing Information, issued October 2019.
asenapine at multiple doses of ≥5 mg twice daily during any phase of a trial within the database of adult Manufactured by: Hisamitsu Pharmaceutical Co., Inc., Japan Saga Tosu © 2019, Hisamitsu Pharmaceutical Co.,
patients. The reactions listed are those that could be of clinical importance, as well as reactions that are plausibly Inc. All rights reserved.
drug-related on pharmacologic or other grounds. Reactions already listed for adult patients in other parts of Distributed by: Noven Therapeutics, LLC, Miami, Florida USA.
this brief summary are not included. Reactions are further categorized by MedDRA system organ class and SECUADO is a registered trademark of Hisamitsu Pharmaceutical Co., Inc.
listed in order of decreasing frequency according to the following definitions: those occurring in at least 1/100 Based on [PI Part Number] [Rev. Date] SDO-1007-16 6/20 Issued:10/2019
patients (frequent) (only those not already listed in the tabulated results from placebo-controlled trials appear
in this listing); those occurring in 1/100 to 1/1000 patients (infrequent); and those occurring in fewer than 1/1000
patients (rare).
Blood and lymphatic disorders: infrequent: anemia; rare: thrombocytopenia
Cardiac disorders: infrequent: temporary bundle branch block
Eye disorders: infrequent: accommodation disorder
Gastrointestinal disorders: infrequent: swollen tongue
General disorders: rare: idiosyncratic drug reaction
Investigations: infrequent: hyponatremia
Nervous system disorders: infrequent: dysarthria
Postmarketing Experience
Choking has been reported by patients, some of whom may have also experienced oropharyngeal muscular
dysfunction.
DRUG INTERACTIONS
CLINICALLY IMPORTANT DRUG INTERACTIONS WITH SECUADO
Antihypertensive drugs (Examples: Diuretics, ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers,
Alpha-Blockers). Because of its α1-adrenergic antagonism with potential for inducing hypotension, SECUADO
may enhance the effects of certain antihypertensive agents. Monitor blood pressure and adjust dosage of
antihypertensive drug accordingly. Strong CYP1A2 Inhibitors (Examples: Fluvoxamine, ciprofloxacin, enoxacin).
Asenapine is metabolized by CYP1A2. Concomitant use of SECUADO with a CYP1A2 inhibitor increases AUC and
Cmax of asenapine. Consider dose reduction for SECUADO based on clinical response. CYP2D6 substrates and
inhibitors (Example: Paroxetine): Asenapine may enhance the inhibitory effects of paroxetine on its own
metabolism by CYP2D6. Concomitant use of SECUADO with paroxetine increases paroxetine AUC and Cmax. Reduce
paroxetine dose by half when paroxetine is used in combination with SECUADO.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Exposure Registry:
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical
antipsychotics, including SECUADO, during pregnancy. For more information contact the National Pregnancy
Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-
andresearch-programs/pregnancyregistry/.
Risk Summary
Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal
and/or withdrawal symptoms. Studies have not been conducted with SECUADO in pregnant women. There
PSY1020__001_018-025_Cover.indd 25 9/30/20 9:06 AM

26
OCTOBER 2020
Psychosomatics w w w. p s y c h i a t r i c t i m e s . c o m
FROM THE ACADEMY OF CONSULTATION-LIAISON PSYCHIATRY
What to Do When Being

main fraught with challenges, both
technologic and patient-based. This
experience demonstrated the short-
There Means Being Vulnerable

comings of being far afield from pa-
tients.
We are dependent on: the hard-
ware and software functioning ade-
» Eva C. Ihle, MD, PhD through an iterative process between
clinicians and leadership.
and infection control protocols in
these hospitals embraced this techno-
quately; the hospital staff designated
as “resource nurses,” who serve as
I
n the early days of the shelter-in- What took longer to establish were logic solution. Arguments in favor of our bridge to the patient by wheeling
place edict that was established in the policies for providing psychiatric this version of consultation were in the computer cart on which the
the San Francisco Bay Area in re- consultation-liaison (C/L) service to made to suggest that the quality of technology runs and being present
sponse to the COVID-19 pandemic, medically hospitalized patients. remote consultation would be ade- with the patient while our team en-
there was some debate about wheth- These policies were hospital-specific quate for the care provided. That may gages with them; and our clinical
er clinical services for patients with and ultimately diverged on the basis be true for straightforward cases. acumen to detect subtle changes in
psychiatric illness were “essential.” of the philosophies held by the lead- However, more often than not, there facial expression, affect, and engage-
The department of psychiatry at my ers of the respective C/L services. are cases that are far from straightfor- ment on a small screen. These tech-
home institution installed a COV- Each university-affiliated hospital ward, which flummox clinician ef- nologic factors are moot when pa-
ID-19 Task Force for patient care, was tasked with developing the proto- forts to use communication-enabling tients refuse to interact with their
appointed by departmental leader- cols that would allow for consulta- technology. consultant over the computer or to
ship and composed of clinicians, re- tions to be provided while taking into The university hospital where I even consent to such an intervention.
searchers, and administrative staff. A account the patient’s COVID-19 sta- am an attending on the adult C/L ser- Even when patients consent to a vir-
remarkable number of departmental tus. The solution that was adopted by vice had years of experience with tual visit, there may be circumstances
meetings were held to eventually the psychiatry C/L services of the 2 remote psychiatric consultation long when their level of disorganization,
conclude that patients with psychiat- hospitals where I attend (a university- before the COVID-19 pandemic. paranoia, distractibility, agitation, or
ric symptoms could still receive care affiliated tertiary care center and a Our team provides consultation to distress prevents them from interact-
from behavioral health clinicians, public safety net hospital) was a ver- multiple affiliated hospitals within ing in a meaningful way with their
psychiatrists included, who were sion of remote consultation via tele- the university health network but is consultant.
now expected to be working from health. headquartered in just one of them. The experiences of the adult psy-
home, even though it has been ar- Most medical specialists who From where we are stationed, our ef- chiatry C/L service described above
gued that psychiatry is an essential were still providing care and meeting forts to provide psychiatric consults informed the child and adolescent
medical service and should be deliv- the expectation of social distancing via technology have been and re- psychiatrists (CAPs) providing con-
ered in person if and when neces-
sary.1 The strategy adopted for ac- Figure. Flowchart of Workflow and Decision Tree for Inpatient Psychiatric Consultations
complishing this goal in the
outpatient setting was conversion of (Daytime 8am - 5pm, Weekdays) Inpatient C/L Service (Nighttime 5pm-8am, Weekends)
all office-based appointments to
telehealth visits on a secure internet
platform. Embedded Child & Adolescent Psychiatrist Cross-Site Coverage
The deliberation was more com-
plicated and the decisions more con- Non-urgent Urgent Emergent
troversial (and less universally ad-
opted) in the hospital setting, for
Curbside Consultation (no SI/HI or COVID-19+) (+SI/HI, regardless of COVID-19 status)
patients, both children and adults,
who were psychiatrically hospital- (with Peds MDs, NPs) Telehealth Consult w/Pt In-Person Consult w/Pt
ized, or who were receiving care in
general medical (non-psychiatric)
hospitals and had psychiatric symp-
toms and/or comorbid psychiatric Behaviorally Appropriate and Verbal? No
illness that required consultation-li-
aison psychiatric care. Directives Yes
from departmental leadership were
rapidly evolving in the first few
weeks of shelter-in-place, and in- Nursing staff informs pt of impending Consult with Psychiatrist dons PPE and scrubs to
cluded such decisions as not psychi- Psych; wheels in iPad Cart (or ensures phone works) engage directly with patient, caregiver
atrically hospitalizing any patient
aged 60 years or older or not having
psychiatry residents interact directly
with patients in emergency rooms. C/L Psychiatry completes consultation, communicates recommendations to consulting team, documents in chart
Fortunately, directives such as these
were quickly revised, presumably
PSY1020_026-027_Psycho.indd 26 9/30/20 8:50 AM

OCTOBER 2020 P S Y C H I AT R I C T I M E S 27
Psychosomatics w w w. p s y c h i a t r i c t i m e s . c o m
sultation to our different pediatrics units, but in dif- this protocol was an adolescent manifesting symp- University of California San Francisco, and
ferent ways. At one site, the patients in the chil- toms of excited catatonia; she paced throughout Zuckerberg San Francisco General Hospital, San
dren’s hospital were evaluated through remote her room during the entirety of the interview and Francisco, CA. Dr Ilhe has no disclosures regarding
consultation unless strict clinical criteria (altered could barely attend to me while in the room with the subject of this article.
mental status or suicidality if not COVID-19 posi- her. It is highly unlikely that I could have engaged
Acknowledgements—Thank you to James Alan Bourgeois,
tive) were met to justify in-person (in-room) con- her and redirected her over a video monitor.
OD, MD, for his support and mentorship, and to all of the
sultation (COVID-19 positive patients were not It came as no surprise that in response to the
physicians on the front lines providing medical care for
offered in-person psychiatric consultation). This COVID-19 pandemic a number of remarkable
patients during the COVID-19 pandemic.
algorithm required the primary pediatrics teams to policy changes occurred, perhaps more quickly
engage with COVID-19 positive patients or their than they otherwise would have. Several innovative REFERENCES
caregivers as a proxy for the CAPs (in the case of programs arose at my home institution to meet the 1. Ihle EC. Psychiatry is an essential medical service during the COV-
ID-19 pandemic. J Psychiatry Reform. 2020;8:1-4.
behavioral dysregulation or other symptoms that mental health needs of medical center staff: resil- 2. Wan W. The coronavirus pandemic is pushing America into a mental
precluded the use of the telehealth device that the ience and emotional well-being videos and webi- health crisis. The Washington Post. May 4, 2020. Accessed September
CAP C/L team relied on). Furthermore, the proto- nars; self-care apps; family support programs; and 15, 2020. https://www.washingtonpost.com/health/2020/05/04/
col did not accommodate patient preference. The direct assessment and treatment for faculty, staff, mental-health-coronavirus
3. Siwicki B. Survey: Americans’ perceptions of telehealth in the COV-
COVID-19-negative patient confronting her can- and trainees. What seemed to be missing from ID-19 era. Heathcare IT News. April 3, 2020. Accessed September 15,
cer diagnosis had to engage with the team psychol- these efforts was comparable attention to the emo- 2020. https://www.healthcareitnews.com/news/survey-americans-
ogist through a device and had to forego the optional and functional well-being of our patients perceptions-telehealth-covid-19-era
4. Ojha R and Syed S. Challenges faced by mental health providers and
portunity for human contact. with psychiatric illness. patients during the coronavirus 2019 pandemic due to technological
The justification for remote consultation was It is becoming all the more clear that additional barriers. Internet Interv. 2020 Sep;21:100330. ❒
the effort to minimize the number of staff exposed support for the increasing mental health needs of
to COVID-19 and thus the likelihood of further patients, especially those with pre-existing psychi-
contagion (presuming staff acted as vectors). How-
ever, the technology still needed human agents to
manipulate it. Those humans were the same front-
atric illness, will be necessary.2 So far, such support
has been surprisingly limited. One program, our
autism clinic, pivoted by establishing a virtual
I Don’t Want
line staff who were expected to do the other tasks
of patient care. Not only did this expectation sug-
“coffee chat” support group function for the par-
ents of patients with autism. to Die Here
in Timbuktu
POETRY OF THE TIMES

gest that their workload could be increased for the More data seem to be collected about the clini-
sake of supporting the CAP C/L team, but also that cians’ experiences of transitioning their services to
the safety of front-line staff could be forfeited for telehealth platforms than the patients’ experiences
the safety of the consultants. of not being seen in person. Professional service
Another benefit that was touted was improved organization listservs have become repositories for Richard M. Berlin, MD
communication and/or collaboration between psy- institutional strategies for converting (in-person)
chiatry consultants and primary teams. For those of inpatient C/L services to telehealth. Ambitious I want to die in Gettysburg, PA
us doing proactive consults, and those who are for- members of these organizations have constructed
tunate enough to be integrated into inpatient teams, methods papers about these strategies. on the soft green flank of Little Round Top
conversion to telehealth would have meant “retreat- Attention is slowly beginning to shift from the where General Pickett led his charge.
ing” from the frontlines and from our role as team- process of providing telehealth to its consequences,
mates. Instead, at the hospital where I am the CAP especially in the area of patient satisfaction3 and I was happy there one afternoon
consultant to the inpatient Pediatrics unit, we devel- mental health care delivery.4 The consequences of
oped a protocol (Figure) for conducting remote these policy changes on the patients’ well-being are before I turned thirteen, the year
consultations for patients who were COVID-19 likely to be profound, and so far the impact of these
my father’s body launched its own Civil War,
positive but not suicidal or homicidal to minimize changes on the needs of this vulnerable population
interactions with the patient. We continued in-per- has not been adequately explored. It makes no sense trees glowing pumpkin and scarlet,
son consultations for everyone who was COVID-19 to deprive patients of the valuable service of in-per-
negative and “persons under investigation” (ie, pa- son consultation if there are no clinical imperatives my mink-coated mother beaming
tients whose test results were pending) or who were to do so. It can, of course, be a reasonable alterna-
at her husband in his houndstooth jacket.
suicidal or homicidal (regardless of COVID-19 sta- tive to no care at all for patients who cannot access
tus). The difference between these circumstances psychiatry through conventional means. We were at peace, ten thousand dead
would be the personal protective equipment (PPE) Technology is a fickle ally. It promises support
we would don (surgical masks and face-shields for but it falls short of authentic connection. In our ef- and thirty thousand wounded
COVID-19-negative patients; N95 respirators, face- fort to open new vistas for consulting on medically
as impossible to imagine as the carnage
shields, gowns, and gloves for COVID-19-positive hospitalized patients with psychiatric symptoms,
patients). Of course, this protocol required the con- we should not lose sight of what our duty to them my father would brave a few months later,
sumption of PPE. was meant to be.
Resources have been scarce, but hospitalized Dedicating ourselves to the principles of social distant drums stirring the first steps
psychiatric patients are just as entitled to medical distancing may have resulted in the perceived aban-
in my long march to become a doctor,
care as any other hospitalized patient, and those donment of our patients. As our subspecialty comes
psychiatrists providing care need to be protected in to terms with the new normal of life in the post-CO- my battle to save him, a surgeon’s scalpel
the same way as other medical specialists. Physi- VID-19 era, it will be important to ensure that the
cians have always recognized that there are risks emotional well-being of our patients is given at least trained on his belly like a bayonet.
inherent in treating patients with medical illness, as much attention as the mental health needs of our
and we have accepted this risk as a hallmark of our colleagues. Access to genuine care should not be
professional duties. relegated to virtual visits.
The protocol that we developed recognized the
importance of being present for the inpatient teams Dr Ihle is Health Sciences Clinical Professor in the Dr Berlin is Instructor in
and the challenges that telepsychiatry can pose for Departments of Psychiatry & Behavioral Sciences Psychiatry, University of
Massachusetts Medical
our patients who are acutely (psychiatrically) and Pediatrics, Langley Porter Psychiatric Hospital
School, Worcester. ❒
symptomatic. The first patient I evaluated using and Clinics, UCSF Weill Institute for Neurosciences,
PSY1020_026-027_Psycho.indd 27 9/30/20 8:50 AM

28
Schizophrenia & Psychosis

OCTOBER 2020 w w w. p s y c h i a t r i c t i m e s . c o m
CASE STUDY
Documenting Recovery in Delusional
Disorder With the MMPI-2
» Alan D. Blotcky, PhD ity Inventory-2 (MMPI-2). There
have been hundreds of studies on the
altered to protect her privacy.)
Mary’s primary symptoms includ-
children at the time of her divorce 4
years earlier; it was not a highly ad-
D
elusional disorder is a major MMPI-2 and the treatment of psychi- ed both persecutory delusions and versarial divorce proceeding. She had
psychotic illness that is enig- atric disorders.4 Up until now, there somatic delusions. Her delusions had no medical problems. She had no
matic and poorly understood. It has been nothing in the literature that been present for about 2 years. She family history of psychosis or other
is often difficult to treat because of the addresses the utility of the MMPI-2 in believed that her colleagues at work psychiatric disorder.
individual’s denial of a problem, dif- tracking or documenting treatment ef- were concocting a scheme to have her Mary had been seeing a psychia-
ficulties in establishing a therapeutic fects in delusional disorder. fired. She believed that her mother trist for several months prior to my
alliance, and interpersonal and social This case illustrates the effective- was not her biological parent. Mary involvement in the case; I obtained
conflicts. Unfortunately, many indi- ness of the MMPI-2 in documenting also believed that drones were hover- her records from him. Mary was
viduals with this disorder refuse treat- patient recovery during treatment for ing over her home and that someone described as having depression and
ment altogether. Available research delusional disorder. Practical implica- had installed a camera in her car to anxiety. Psychosis was not noted.
suggests that 50% of patients who are tions for psychiatrists and other men- follow her. She reported unrelenting She was being treated with fluoxetine
adequately treated achieve a symp- tal health professionals are discussed. somatic symptoms that she attributed 20 mg and bupropion hydrochloride
tom-free recovery, while 90% of pa- “Mary,” a 42-year-old white fe- to an alien virus that had been planted extended-release tablets 150 mg, but
tients demonstrate at least some im- male, temporarily lost custody of her in her water at home. Because of her she was not improving. Mary had not
provement.1 It has been found that 3 children to her ex-husband 18 delusional thinking, Mary had recent- divulged any delusional material to
persecutory delusions respond least months ago due to apparent psychot- ly quit her job and was residing with her psychiatrist.
well to treatment, with 50% improve- ic-level functioning. I was appointed her parents. Clinically, Mary was appropriate-
ment rates and no reports of complete by the court to arrive at a definitive Prior to the onset of her delusions, ly attired and well-groomed for her
recovery.2 Only a handful of studies diagnosis and to provide appropriate Mary had obtained 2 master’s de- sessions with me. She wore make-up
have used objective outcome mea- guidance about her parenting abili- grees and had a full-time posi- and jewelry. She was pleasant with
sures to evaluate patient improvement ties and custody status. (Mary, a tion. She had a boyfriend, many me and made good eye contact.
during treatment for delusional disor- pseudonym, has given written in- friends, and her family relationships Mary’s cognitive abilities were in-
der.3 The best objective measure of formed consent for her case to be in- were intact. She was described as a tact. Her affect was slightly dysphor-
adult psychopathology in the world is cluded in this presentation. Identify- smart and sweet person. She had ic but within normal limits. She was
the Minnesota Multiphasic Personal- ing information about her has been been given primary custody of her 3 not manic or hypomanic. Mary’s de-
lusions were prominent, and she had
little or no insight into their nature
and severity. She was also suspicious
“It is often difficult to treat because of me; she thought I might be in-
volved in the conspiracy with her col-
of the individual’s denial of a leagues at work.
I asked Mary to provide a urine
problem, difficulties in establishing screen to rule out substance abuse.
Her urine screen the same day was
a therapeutic alliance, and negative for illicit drugs.
Mary completed the MMPI-2, an-
interpersonal and social conflicts.” swering all 567 questions in 90 min-
utes. Her responses were scored on 3
validity scales, 10 basic clinical scales,
and the PSY-5 supplementary scales.
Mary showed considerable dis-
tress but in the context of normal va-
lidity scales. She approached the test
in an open and honest fashion. She
did not exaggerate her symptoms.
AUNGMYO@STOCK.ADOBE.COM
She was not defensive or guarded.

Her responses were considered valid.
She was to be believed.
Ten basic clinical scales were de-
veloped to assess different psychiat-
ric conditions and symptoms. See
Table below for a description of the
PSY1020_028-029_Schiz-Blotcky.indd 28 9/30/20 8:49 AM

OCTOBER 2020 Schizophrenia P S Y C H I AT R I C T I M E S 29
& Psychosis w w w. p s y c h i a t r i c t i m e s . c o m
Table. Clinical Scales of the MMPI 2 chotic medication (ziprasidone 20 to her therapeutic alliance with her
mg). This finding is contrary to the psychiatrist and me. Her motivation
Number Abbreviation Description
data that suggest that persecutory de- to get well superseded any desire to
1 Hs Hypochondriasis lusions are recalcitrant.2 Mary did not resist intervention. Therapeutic alli-
2 D Depression have a comorbid condition, and the ance is a critical building block in
absence of comorbid conditions may adequate treatment.6
3 Hy Hysteria make successful treatment of delu- Whether Mary will have a recur-
4 Pd Psychopathic deviate sional disorder more attainable.7 rence in her delusional disorder is
Overall, Mary’s recovery was unclear. Longitudinal research is
5 MF Masculinity/femininity likely due to a combination of the needed to address the question of in-
6 Pa Paranoia relatively short duration of her delu- cidence recurrence in this specific
sions (about 2 years), the lack of a illness. With other types of psychotic
7 Pt Psychasthenia
comorbid condition, the use of an an- disorders, recurrences are often ex-
8 Sc Schizophrenia tipsychotic medication, the discon- pected and even inevitable.8 As such,
Ma Hypomania
tinuance of bupropion, and her high maintenance treatment in delusional
9
level of premorbid functioning. disorder becomes extremely impor-
0 Si Social introversion The MMPI-2 proved to be a sensi- tant. Treatment should include a
tive outcome measure in evaluating combination of psychiatric medica-
10 scales. Mary’s 10 basic clinical ing. I interviewed Mary on 2 occa- this patient’s improvement. Using the tion and individual therapy.3
scales showed significant elevations sions. She completed the MMPI-2 MMPI-2 at the time of diagnosis and The impact of psychotic disorders
on scales 6-8-1-3. Scales 6 and 8 again, and I obtained updated records later during treatment is an objective, on child custody cases is a delicate mat-
were considerably higher than scales from her psychiatrist. data-driven way to assess a patient’s ter. It should be recognized by all par-
1 and 3. While this profile often indi- After 4 months on ziprasidone, response to treatment. The MMPI-2 ties that a parent’s recovery from a psy-
cates schizophrenia, Mary’s history Mary was remarkably improved. She can be administered easily and is not chotic disorder may be less than
and clinical presentation were not was tolerating it well, and her delu- overly intrusive. permanent. Child custody decisions
consistent with that illness. In my sions had remitted. She had need to be made with that psychiatric
view, Mary’s MMPI-2 profile was developed important insight about reality in mind. Maintenance treatment
reflective of her persecutory delu- her resolved delusions. They now Available research suggests that for the parent with a psychotic disorder
50%
sions (scales 6 and 8) and her somatic seemed foreign and distant to her; is the vehicle by which parenting abili-
delusions (scales 1 and 3), both com- they did not make sense to her. She ties can be regained and sustained.9,10
ponents in her psychotic illness. could not even recall her suspicious-
Supplementary scales are available ness about me. Mary’s affect was Dr Blotcky is a clinical psychologist in
on the MMPI-2 as well. Mary’s PSY- bright. She was talkative and expres- private practice in Birmingham,
5 scales showed a significant eleva-
tion on the scale having to do with
sive. She was appreciative of every-
one’s concerns. Mary was looking
of patients Alabama. He is clinical associate pro-
fessor, department of psychology,
psychosis. This was corroborative for a full-time job and planned to get who are adequately treated achieve University of Alabama at Birmingham.
data to Mary’s 10 basic clinical scales. her own apartment. a symptom-free recovery, while Much of his clinical practice is devoted
90%
Based on her history, clinical ob- Mary’s MMPI-2 after 4 months of to forensic cases, including child custo-
servations, and MMPI-2 test data, I treatment was remarkable as well. It dy, personal injury, and criminal cases.
diagnosed Mary with delusional dis- was completely normal. Her validity REFERENCES
order. Her delusional disorder was scales were normal. All 10 basic clini- 1. Bourgeois JA. Delusional disorder: Overview, diag-
primary. She did not have a comorbid cal scales were normal; there were no nosis, epidemiology. 2017. Medscape eMedicine.
condition, such as bipolar disorder or significant elevations. In fact, there of patients 2. Pillmann F, Wustmann T, Marneros A. Acute and
transient psychotic disorders versus persistent delu-
schizophrenia. Mary did not have were no near-significant elevations. Her
major depressive disorder or an anxi- PSY-5 scales were normal as well. All
demonstrate at least some sional disorders: a comparative longitudinal
study. Psychiatry Clin Neurosci. 2012;66(1):44-52.
ety disorder nor was she abusing al- signs of psychosis had dissipated. improvement.1 3. O’Connor K, Stip E, Pélissier MC, et al. Treating
cohol or drugs. Mary will be maintained on ziprasi- delusional disorder: a comparison of cognitive-be-
havioural therapy and attention placebo control. Can
No specific stressors were identi- done for the foreseeable future. She J Psychiatry. 2007;52(3):182-190.
fied that contributed to the onset of will have monthly to quarterly visits Concluding thoughts 4. Butcher JN. Significant contributions for use of the
Mary’s delusional disorder. Howev- with her psychiatrist. Cognitive behav- Lessons learned from this case study MMPI/MMPI-2 in treatment. 2016. Semantic Scholar. Ac-
er, she was feeling “pressure” from ior therapy has been added to her treat- are clinically interesting, but only cessed September 8, 2020. https://pdfs.semantic
scholar.org/cd97/a44d879d3db42721556ca74588
juggling a full-time job with raising 3 ment regimen, since it is regarded as a suggestive. Well-designed research is 543aa68227.pdf
children. critical component in the maintenance needed to study the proposition that 5. Kesby, JP, Eyler, DW, McGrath, JJ, Scott, JG. Dopa-
Interestingly, Mary’s psychiatrist of recovery.6 Mary’s legal case is close the MMPI-2 is a highly effective in- mine, psychosis and schizophrenia: the widening gap
and I independently but simultane- to resolution. With her regained par- strument for evaluating treatment between basic and clinical neuroscience. Transl Psy-
chiatry. 2018;8:30.
ously came to the conclusion that she enting abilities, the parties are ap- outcome in delusional disorder. 6. Roudsari MJ, Chun J, Manschreck TC. Current
had delusional disorder. Mary was proaching a compromised settlement. Mary’s psychiatrist and I worked treatments for delusional disorder. Curr Treat Options
started on ziprasidone 20 mg. Fluox- independently but in a cooperative Psych. 2015; 2:151-167.
etine 20 mg was continued. A brain Discussion fashion. This was quite helpful in fa- 7. González-Rodríguez A, Molina-Andreu O, Odrio-
zola VN, Ferrer CG, Penadés R, Catalan R. Delusional
MRI at that time was negative. Bu- This case study illustrates many im- cilitating Mary’s evaluation and treat- disorder: An overview of affective symptoms and
propion was stopped because it en- portant clinical and practical points. ment with minimal delays and road- antidepressant use. The European Journal of Psy-
hances dopamine levels and can con- Mary’s persecutory delusions and blocks. The sharing of findings and chiatry. 2013;27(4):265-276.
tribute to psychosis.5 somatic delusions both abated with conclusions between us led to an excel- 8. Rajkumar RP. Recurrent acute and transient psy-
chotic disorder: A pilot study. Asian J Psychiatr.
I re-evaluated Mary 4 months later treatment. This result is consistent lent result after much initial confusion.
2015;14:61-64.
in preparation for her upcoming court with the literature that reports that Mary was fully adherent with her 9. Deutsch RM, Clyman J. Impact of mental illness on
appearance. The court would want to 50% of patients treated adequately evaluation and treatment, whereas parenting capacity in a child custody matter. Family
hear about my findings and conclu- achieve a symptom-free recovery.1 many patients with delusional disor- Court Review. 2016; 54(1):29-38.
10. Engur B. Parents with psychosis: Impact on par-
sions as well as any progress in her Delusional disorder in this case was der refuse treatment. Mary’s success-
enting and parent-child relationship. Journal of Child
condition since her last court hear- treated successfully with antipsy- ful treatment was largely attributable and Adolescent Behavior. 2017;5(1):327. ❒
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30
Anxiety & Stress Disorders

October 2020 w w w. p s y c h i a t r i c t i m e s . c o m
Managing Distress in Health

Care Workers During COVID-19:
Lessons From a Disaster Trauma Lens
» Gertie Quitangon, MD tions, promoting effective coping and
adaptation strategies, and encouraging
Figure 1. Psychological Phases of Disaster10
overall wellness and resilience.6 Disas- HONEYMOON
C
COMMUNITY COHESION
oronavirus disease 2019 (CO- ter mental health assistance during the RECONSTRUCTION
VID-19) blindsided the world. acute phase is often more practical than HEROIC A NEW BEGINNING
It exposed gaps in public health psychological in nature. In this case, PREDISASTER DISILLUSIONMENT
S) IEF
emergency planning at every level, in- such assistance includes Centers for E RM GR
THREAT T H
TO OUG
cluding in the strategic planning to Disease Control information and up- WARNING IMPACT I NG THR
support mental health and wellness. dates, access to food and cleaning sup- OM G
(C KIN
R
Studies of the SARS and Ebola epi- plies, access to COVID-19 testing, pro- WO
demics as well as natural disasters tective equipment, financial assistance, INVENTORY TRIGGER EVENTS AND
have taught us lessons about the im- and links to community resources. ANNIVERSARY REACTIONS
portance of planning for and respond- After the acute phase of the disas- -----------------1 TO 3 DAYS ----------- TIME ----------- 1 TO 3 YEARS -----------------
ing to the mental health needs of health ter, long-term stress responses can
care and frontline workers.1 Thus, this emerge. Lancee et al.7 found that 2 events (Figure 1), identify the chang- high of nearly 800 per day across the
is a pivotal moment, a chance to im- years after the SARS outbreak, health ing goals of recovery at different state down to none in New York City by
plement systems and structures for care workers who treated these pa- phases (Figure 2), and inform miti- June. Now the focus is shifting to eco-
staff support in every organization and tients had elevated rates of smoking gation strategies. It is important to nomic recovery, while keeping commu-
advance staff wellness and resilience and drinking, absenteeism due to note that the timing of the phases is nity viral transmission low and bracing
initiatives. stress or illness, decreased face-to- fluid. They do not occur in an exact for a potential second wave. This could
face contact with patients, and de- sequence. Phases can overlap and be the beginning of the reconstruction
Disaster literature creased work hours.Yet rates of de- move forward or back across a time- phase: figuring out a new normal and
The literature on disasters and public pression, posttraumatic stress line, depending on the type of disaster. how to live with a persisting virus. Dis-
health emergencies describes pervasive disorder, and other mental illness were Figure 1 depicts the stages of pub- illusionment is certainly felt when other
emotional distress, feelings of extreme not elevated. This is consistent with lic reactions to natural disasters like states are unable to control the virus, in
vulnerability, uncertainty, and threats to existing research, which has found 2012’s Hurricane Sandy and even the spite of the availability of immense re-
life, particularly during the rapid spread that the long-term impact of massive 9/11 terrorist attacks in 2001, but the sources and clear and concrete direc-
of an outbreak.2 A recent COVID-19 disasters is predominantly in the range community response to a pandemic tions from world-class health experts to
web-based survey supports this finding. of subsyndromal stress responses seems more unpredictable. The im- wear masks, avoid crowds, maintain
More than 40% of respondents report- rather than an increase in psychiatric mediate COVID-19 experience in social distance, and wash hands.
ed symptoms of depression, anxiety, morbidity. Limited long-term studies New York state in the spring of 2020
traumatic stress, substance use, and sui- suggest that post-disaster symptom- was marked by safety concerns, Supporting staff
cidal ideation. Symptoms were notably atology peaks in the first year and then deaths in the thousands, food and job Studies indicate that during an infec-
elevated in black and Hispanic indi- declines, but the course of recovery is insecurity, financial hardships, and tious disease outbreak, the operation-
viduals, essential workers, unpaid adult variable.8 The challenge for mental anger at government response. We al response of an organization is likely
caregivers, and those with psychiatric health clinicians is to distinguish nor- do, however, see a heroic phase ex- the single most important factor influ-
conditions.3 Fortunately, evidence from mal distress reactions to catastrophes emplified by the emergence of he- encing staff perception of both stress
disaster trauma research has shown from exacerbation of existing mental roes, such as Anthony Fauci, MD, on and safety.12 Traumatic events can dis-
that, ultimately, most people are resil- health susceptibilities or new-onset the national level and Governor An- rupt feelings of safety, trust, control,
ient even after the most severe traumat- disaster-related pathology. drew Cuomo in New York state. We esteem, and intimacy. As a result,
ic event.4,5 In the immediate aftermath Disaster trauma is characterized by then witnessed community cohesion staff can exhibit maladaptive behav-
of large-scale catastrophes, a majority exposure to personal loss and com- typical of the honeymoon phase as iors or experience traumatic stress
of negative mental health symptoms are munity disruption. Cultural, political, New Yorkers connected with each symptoms.13 Best practices to miti-
recognized as distress reactions to in- and socioeconomic factors all influ- other from stoops, windows, terraces, gate the disruptions and support staff
tense and overwhelming events. They ence the shared experience of major and rooftops, all cheering for front- during a pandemic involve 4 key ele-
are not pathologized or labeled psychi- disasters.9 Looking through a disaster line workers at 7:00 PM each night to ments: leadership, communication,
atric disorders. The disaster literature trauma lens, a better understanding of show gratitude and appreciation. education, and social support.
emphasizes the importance of ac- the emotional stages of public reac- New York successfully flattened the
knowledging the normality of distress tion can help: anticipate community curve by the summer. The number of LEADERSHIP. Strong leadership and
reactions, identifying high-risk popula- responses to large-scale catastrophic daily deaths fell dramatically, from a supportive teams influenced the re-
silience of health care workers during
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October 2020 Anxiety & Stress P S Y C H I ATR I C T I M E S 31
Disorders w w w. p s y c h i a t r i c t i m e s . c o m
the SARS and Ebola outbreaks.12 Capable and ef- of infection control, disaster mental health, and the huddles to build relationships and improve
fective leadership over the course of a major disas- disaster response system increases confidence and responsiveness.
ter makes staff feel safe and supported by the orga- moderates the risk of stress. Just as Federal Emer- Establish buddy system to check and balance
nization. Best practices include: gency Management Agency (FEMA) provides ap- each other’s stress level.
isible and prepared leaders at organizational,
V propriate resources and training for disaster re- The scarcity of existing research on staff support
departmental, and team levels. sponders before deployment, organizations have a and mitigation strategies during pandemics pres-
responsibility to provide education and training to ents an opportunity to develop new programs that
Setting the tone for a positive and supportive
better prepare for and respond to a pandemic. Or- can be tailored to specific organizational contexts
organizational culture.
ganizations should be prepared to offer staff: and cultures. Evaluation of best practices and ro-
Skilled assessment of team strengths and
weaknesses. eneral information on disasters and
G bust analysis of the impact and sustainability of
pandemics. staff support plans during COVID-19 can inform
Proactive outreach and crisis support from all
Education on infection control and universal future strategic planning and policy recommenda-
levels of leadership.
precautions. tions for staff wellness and resilience.
Creativity and innovation in increasing staff
resilience and reducing stress. Overview of disaster mental health.
Targeted education on key sources of distress
Dr Quitangon is clinical assistant professor of psy-
Role modeling infection control and safety
from COVID-19 (eg, quarantine-related distress,
chiatry, New York University School of Medicine and
practices—wear masks, practice physical
fear of contagion, concern for family, job stress,
psychiatrist at the Department of Veterans Affairs
distancing, and wash your hands.
financial concerns, interpersonal isolation,
New York Harbor. Dr Quitangon discloses that she
receives royalties from Routledge for her book
COMMUNICATION. The cornerstone of infectious stigma).
Vicarious Trauma and Disaster Mental Health:
disease management is communication, coordina-
tion, and collaboration.14 Delivery of clear, transpar- SOCIAL SUPPORT. Studies indicate that social sup- Understanding Risks and Promoting Resilience.
ent, timely, trustworthy information in a rapidly port, both personal and professional, is a consistent
protective factor and a strong mitigator of emotional Acknowledgement — The author wishes to acknowledge
evolving situation is essential. Organizations should
distress in the wake of a massive disaster.15,16 Unfor- Mary Docherty, MA, MBBS (Hons), MRCP, MRCPsych, for
be prepared to:
tunately, the battle against COVID-19 calls for de- her work in planning and development of the COVID-19
ommunicate timely and trustworthy COVID-
C staff support response at St Thomas’ Hospital and King’s
creased interpersonal contact. Quarantine, physical
19-specific guidance. College Hospital in London, England.
distancing, and remote and virtual work have all
Acknowledge and normalize feelings of anxiety increased social isolation. This unprecedented pub-
related to the pandemic. lic health crisis requires creativity and innovation to REFERENCES
Communicate efforts to address the negative 1. World Health Organization. WHO checklist for influenza pandemic pre-
restore a sense of community and connectedness. In
paredness planning. 2005. Accessed September 8, 2020. https://www.who.
impacts of the pandemic, including financial order to provide much-needed social support during int/influenza/resources/documents/FluCheck6web.pdf?ua=1
concerns. difficult times, organizations should prepare to: 2. Chong MY, Wang WC, Hsieh WC, et al. Psychological impact of severe
Communicate supportive organizational acute respiratory syndrome on health workers in a tertiary hospital. Br J
old virtual meetings and virtual lunch/coffee
H Psychiatry.2004; 185:127-133.
practices (eg, working from home, flexible work
breaks/happy hours to improve team cohesion 3. Czeisler ME, Lane RI, Petrosky E, et al. Mental health, substance use,
schedule, reduced hours, job rotation, location
and morale. and suicidal ideation during the COVID-19 pandemic. MMWR Morb Mor-
rotation, availability of PPE, testing). tal Wkly Rep. 2020; 69(32):1049-1057.
Build in formal time during work hours for peer
Widely disseminate available self-care and 4. North CS, Pfefferbaum B, Hong B. Historical perspective and future direc-
consultation to reduce feelings of isolation and tions in research on psychiatric consequences of terrorism and other disas-
wellness information and resources.
increase feelings of efficacy. ters. In: Neria Y, Gross R, Marshall R, Suzzer E, eds. 9/11: Mental Health in the
Wake of Terrorist Attacks. Cambridge University Press; 2006:95-113.
EDUCATION. Training and education on the issues Use in-person or virtual service meetings and
5. Norris, F. Community and ecological approaches to understanding and
alleviating postdisaster distress. In: Neria Y, Gross R, Marshall R, Suzzer
E, eds. 9/11: Mental Health in the Wake of Terrorist Attacks. Cambridge
Figure 2. Changing Goals of Recovery at Different Phases of Disaster11 University Press; 2006:141-156.
6. North CS, Pfefferbaum B. Mental health response to community disas-
HONEYMOON RECONSTRUCTION
ters: A systematic review. JAMA.2013;310(5):507-518.
7. Lancee WJ, Maunder RG, Goldbloom DS. Prevalence of psychiatric
COMMUNITY COHESION A NEW BEGINNING disorders among Toronto hospital workers one to two years after the
SARS outbreak. Psychiatr Serv. 2008;59(1):91-95.
HEROIC 8. Norris F, Friedman M, Watson P. 60,000 disaster victims speak. Part 1:
PREDISASTER An empirical review of the empirical literature, 1981-2011. Psychiatry.
DISILLUSIONMENT 2002; 65(3):207-239.
9. Zinner ES, Williams, MB. When a community weeps: Case studies in
WARNING S I EF group survivorship. Brunner/Mazel; 1999.
THREAT E RM GR 10. Zunin, LM, Myers, D. Training manual for human service workers in
T GH major disasters (2nd ed.). DHHS Publication No. ADM 90-538. Department
IMPACT TO OU of Health and Human Services; 2000.
G R
M IN TH 11. Quitangon, G. What do we need to know about disasters? In: Quitangon
G
CO KIN
G, Evces MR, eds. Vicarious Trauma and Disaster Mental Health: Under-
standing Risks and Promoting Resilience.: Routledge; 2015:156-172.
OR 12. Grace SL, Hershenfield K, Robertson E, Stewart DE. The occupa-
W
TRIGGER EVENTS AND tional and psychosocial impact of SARS on academic physicians in three
affected hospitals. Psychosomatics. 2005; 46(5):385-391.
INVENTORY ANNIVERSARY REACTIONS 13. Quitangon G, Evces, MR. What can organizations do to address vi-
carious trauma in disasters? In: Quitangon G,Evces, MR (eds.). Vicarious
Trauma and Disaster Mental Health: Understanding Risks and Promoting
1 TO 3 DAYS ------------------------ TIME ------------------------ 1 TO 3 YEARS Resilience. Routledge; 156-172.
14. Perrett K, Al-Wali W, Read C, et al. Outbreak of meningococcal disease in
PRE-DISASTER PHASE ACUTE PHASE POST-ACUTE PHASE Rotherham illustrates the value of coordination, communication, and collabora-
 establish trusting  ensure safety  regain a sense of mastery tion in management. Commun Dis Public Health.2000;3(3):168-171.
relationships 15. Norris, F, Kaniasty K. Perceived and received social support in times of
 diminish suffering and control stress: A test of the social support deterioration deterrence model. Journal
 evaluate planning and  preserve function  resume roles and activities of Personality and Social Psychology. 1996; 71(3):499-511.
preparation efforts  promote resilience  develop new normal routine 16. Brewin CR, Andrews B, Valentine, JD. Meta-analysis of risk factors
 empower by education for posttraumatic stress disorder in trauma-exposed adults. Journal of
Consulting and Clinical Psychology. 2000; 68(5):748-766. ❒
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32
OCTOBER 2020
Mood Disorders w w w. p s y c h i a t r i c t i m e s . c o m
BIPOLAR UPDATE
Oxcarbazepine: Does It Have
a Role in Bipolar Disorder?
» David N. Osser, MD provement in the scores. However,
the response rates were 42% with ox-
often with oxcarbazepine include
liver enzyme elevations (it is not me-
mg to the maximum dose of 2400
mg, if needed and tolerated. Serum
O
xcarbazepine (formerly brand- carbazepine and 26% with placebo, tabolized and is renally excreted), se- levels are not available.
ed as Trileptal) is an anticon- which looks like it could have be- rious rashes including Stevens-John- In conclusion, it seems that oxcar-
vulsant that is structurally very come a significant difference if the son syndrome, leucopenia, sedation, bazepine could be a consideration for
similar to carbamazepine, which is cohort had been larger. and other rashes. It is a weaker induc- patients who you want to treat with
US Food and Drug Administration- carbamazepine for mania (as mono-
approved for acute or mixed mania therapy or adjunct) but for whom it
but not well studied for depression. would be unsafe or who have been
Both are thought to work by the same unable to tolerate it. It is unlikely to
mechanism(s). The drug came to “Both oxcarbazepine and carbamazepine be of value for someone who had an
market as an anticonvulsant with very adequate trial of carbamazepine and
little time left on its patent protection, are weight-neutral, but they can cause has not responded. The evidence
and it very quickly became a generic
product. There was not enough time
double vision and vertigo.” base for treating or preventing bipo-
lar depression is very weak for both.
to do any significant studies on other
possible uses such as in bipolar disor- Dr Osser is associate professor of psy-
der before the patent ran out. Hence, chiatry, Harvard Medical School, and
there are very little data pertinent to Oxcarbazepine has a somewhat er of cytochrome P450 3A4 com- Consulting Psychiatrist, US
its efficacy or effectiveness for bipo- milder adverse effect profile compared with carbamazepine and thus Department of Veterans Affairs,
lar mania or depression. What data pared with carbamazepine. Probably has fewer drug interactions. Both ox- National Telemental Health Center,
are available are at best inconclusive,1 the most significant risk with oxcar- carbazepine and carbamazepine are Bipolar Disorders Telehealth Program,
but Maudsley Prescribing in Psychia- bazepine is hyponatremia; this most weight-neutral, but they can cause Brockton, MA. He is a member of
try, citing 8 pertinent reports, rate it as often occurs in the first 3 months of double vision and vertigo. Slower ti- Psychiatric Times® Editorial Board.
“probably effective” for mania—the use, but it can occur later. Although tration may minimize these and other The author reports no conflicts of in-
only medication with that rating in a few head-to-head comparisons are adverse effects. Teratogenicity is a terest concerning the subject matter
table of 13 off-label possible alterna- available,2 the incidence might be severe problem with carbamazepine; of this article.
tive treatments.2 higher in oxcarbazepine than with the incidence is unclear with oxcar- REFERENCES
The only placebo-controlled study carbamazepine. The overall rate is bazepine but it probably should be 1. Vasudev A, Macritchie K, Vasudev K, et al. Oxcar-
was in children and adolescents.3 The about 2% to 3%, but concomitant se- considered to be an equally high risk bazepine for acute affective episodes in bipolar disor-
der. Cochrane Database Syst Rev. 2011;(12):CD004857.
study included a total of 116 patients lective serotonin reuptake inhibitors in women of child-bearing potential.
2. Taylor DM, Barnes TRE, Young AH. The Maudsley
with symptoms of mania aged 7 to 18 (which can lower sodium by a differ- Dosage of oxcarbazepine is about Prescribing Guidelines in Psychiatry, 13th Edition.
years who were randomized to ox- ent mechanism) probably increase one-third higher than with carbam- Hoboken, NJ: Wiley Blackwell; 2018: 237.
carbazepine or placebo. There was this risk. Sodium monitoring should azepine. The same dose has been 3. Wagner KD, Kowatch RA, Emslie GJ,et al. A double-
blind, randomized, placebo-controlled trial of oxcar-
no significant difference on the occur monthly for the first 3 months used for bipolar mania as is used for
bazepine in the treatment of bipolar disorder in chil-
Young Mania Rating Scale, nor on and every 3 to 6 months thereafter. seizure disorders; begin with 300 mg dren and adolescents. Am J Psychiatry. 2006;163:
rate of response defined as a 50% im- Adverse effects that appear less bid and increase every 3 days by 300 1179-1186. ❒
This Month on Our Website Check Out These Features on Our Website:
www.psychiatrictimes.com
PODCASTS SLIDESHOWS
Dosing Tips for Bipolar Disorder: Quetiapine Quick reference to noteworthy studies and tipsheets.
Chris Aiken, MD, Kellie Newsome, PMH-NP
psychiatrictimes.com/view/dosing-tips-bipolar-disorder-quetiapine 10 Factors That Influence Treatment Outcomes
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Dosing Tips: Lithium for Bipolar Disorder psychiatrictimes.com/view/
Chris Aiken, MD, Kellie Newsome, PMH-NP 10-factors-that-influence-treatment-outcomes
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PSY1020_032_Osser-Mood.indd 32 9/30/20 8:46 AM

33
Neuropsychiatry October 2020
Easy To Miss, Hard to Treat:

Notes on Frontotemporal Dementia
» Rajesh R. Tampi, MD, MS, DFAPA, DFAAGP, Deena J. Tampi, MSN, MBA-HCA, RN, DFAAGP, and Michael Parish, MD
T
he term frontotemporal dementia (FTD) de- Table 1. Diagnostic Criteria for the FTD Variants
scribes a group of neurodegenerative disor- bvFTD  Progressive deterioration of behavior or  Definitive bvFTD is diagnosed when an
ders that are characterized by the clinical syn- cognition (by observation or by history individual meets the criteria for possible
drome of progressive dysfunction in executive provided by a reliable caretaker or informant). bvFTD and has 1 or both of the following:
P ossible bvFTD is diagnosed if 3 or more 1. histopathological evidence of FTD; or
functioning, behaviors, and language.1 FTD is 2. evidence of a known pathogenic
thought to be the third most common type of de- of the following are present:
1. early behavioral disinhibition mutation
mentia after Alzheimer disease (AD) and dementia 2. early apathy or inertia  bvFTD is excluded if the individual’s
with Lewy bodies. FTD is also a common type of 3. early loss of sympathy or empathy presentation is better accounted by:
early-onset dementia (occurring among individu- 4. early perseverative, stereotyped, or 1. another nondegenerative nervous
als 65 years or younger).2 compulsive/ritualistic behavior system or medical disorder; or
5. hyperorality and dietary changes 2. a psychiatric diagnosis; or
FTD was noted in 1892 by Arnold Pick, MD, 6. neuropsychological profile: executive/ 3. another neurocognitive disorder or
when he described an individual who presented generation deficits with relative sparing of neurodegenerative process such as AD,
with aphasia, temporal lobar atrophy, and presenile memory and visuospatial functions which is strongly indicated by a biomarker
dementia.2 In 1911 the association between Pick P robable bvFTD diagnosis would need to
bodies and FTD was described by Alois Alzheimer, meet criteria for possible bvFTD + imaging
suggestive of frontal or anterior atrophy on
MD, PhD, who named the disorder “Pick’s dis- MRI or CT
ease.” The term Pick’s disease became synony-
mous with FTD, referring to both the clinical syn- PPA  Prominent difficulty with language is the  PPA diagnosis is excluded if:
principal cause of impaired daily activities, 1. the presenting symptoms are more
drome and the pathological diagnosis. Currently, with aphasia being the most prominent consistent with another neurocognitive
“Pick’s disease” is used only to describe the patho- deficit at symptom onset and during the disorder, medical condition,
logical diagnosis. In 1982, M. Marsel Mesulam, initial phase of the disease. neurodegenerative process, or psychiatric
MD, identified the language subtype of FTD: pri- diagnosis; or
2. if there are prominent initial episodic
mary progressive aphasia (PPA). memory, visual memory, or visuospatial
Available evidence indicates that FTD is the impairments; and initial behavioral
second most common cause of dementia among in- disturbance.
dividuals 65 years or younger.1 The prevalence of
nfvPPA  The diagnosis requires at least 1 of 2 core  The imaging-supported nfvPPA variant is
FTD among individuals with early-onset dementia is features: diagnosed when there is:
between 3% and 26%. The population prevalence of 1. agrammatism in language production 1. imaging that demonstrates predominant
FTD varies between 1 to 26 per 100,000.2 These 2. effortful and halting speech that is not left posterior fronto-insular atrophy on MRI;
numbers probably underestimate the true prevalence, consistent with speech apraxia or
and shows 2 of 3 of the following features: 2. predominantly left posterior fronto-
as the disorder is often missed or misdiagnosed. 1. impaired comprehension of complex insular hypoperfusion or hypometabolism
sentences on SPECT or PET.
Subtypes 2. spared single-word comprehension  nfvPPA with definite pathology is
FTD has 2 main subtypes, based on their predomi- 3. spared object knowledge diagnosed when there is:
1. histopathologic evidence; or
nating presentations: the behavioral variant of FTD 2. the presence of a known pathogenic
(bvFTD), and the language variant, ie, PPA.3 Based mutation.
on the localizations and underlying cerebral dys-
function, the language variant can be further subdi- svPPA T
he diagnosis requires impairment in  For an imaging-supported diagnosis, there
confrontation naming (ie, difficulty naming must either be:
vided into the nonfluent variant of PPA (nfvPPA) or recognizing objects or drawings) + 1. predominant anterior temporal lobe
and the semantic variant of PPA (svPPA). Male impaired single-word comprehension + at atrophy; or
predominance has been noted in the bvFTD and least 3 of the following: 2. predominant anterior temporal
svPPA variants and female predominance in the 1. impaired object knowledge hypoperfusion/hypometabolism on SPECT
2. surface dyslexia (ie, inability to recognize or PET.
nfvPPA variant. Table 1 details the diagnostic cri- words as a whole) or dysgraphia  For a definite pathology diagnosis, there
teria of FTD’s 3 variants.4,5 3. spared repetition must be:
A third variant of PPA has been described as 4. spared speech production 1. histopathologic evidence; or
logopenic PPA (lvPPA), in which individuals ex- 2. the presence of a known pathogenic
mutation.
hibit specific impairment with confrontation nam-
ing or word-finding difficulties and impaired sen- AD, Alzheimer disease; bvFTD, behavioral variant FTD; FTD, frontotemporal dementia; nfvPPA, nonfluent variant PPA;
PPA, primary progressive aphasia; SPECT, single-photon emission CT; svPPA, semantic variant PPA.
tence repetition.1,6 Neuroimaging studies among
these individuals demonstrate predominant left evidence or the presence of a known pathogenic individuals with bvFTD have concomitant motor
posterior perisylvian or parietal atrophy/hypoper- mutation allow for a definite diagnosis of FTD. neuron disease.7 In addition, 27.3% of individuals
fusion/hypometabolism. Definite histopathologic Evidence indicates that approximately 12.5% of have features of minor motor system dysfunction,
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34 October 2020
P S Y C H I ATR I C T I M E S
w w w. p s y c h i a t r i c t i m e s . c o m Neuropsychiatry
Table 2. Differentiating Clinical Features: 4 Types of Dementia

carefully evaluated. A thorough his-
Features FTD AD VD LBD tory from the individual and a reliable
Presenile or Presenile Senile Senile Senile collateral source that tracks the pro-
senile onset gression of behavioral and cognitive
symptoms are essential. A focused
Symptom onset Insidious Insidious Variable Insidious
physical examination that identifies
Stepwise progression
parkinsonian and/or upper motor neu-
Cognitive Executive Memory decline Executive dysfunction Memory decline ron signs will assist in the diagnosis.
features dysfunction Executive Memory decline Visuospatial deficits Laboratory testing (including com-
dysfunction Executive dysfunction plete metabolic panel, complete blood
Parkinsonian and Rare Variable, depending Parkinsonian symptoms
count, thyroid function tests, liver
Motor symptoms
ALS symptoms Apraxia in severe on location of lesions occurring along with, or within function tests, vitamin B12 levels,
in some cases stages 1 year of, cognitive symptoms and urine drug screen) should be done
to rule out reversible causes of cogni-
Progression 6-8 years 8-10 years 3-5 years 6-8 years tive and behavioral impairments.
Among atypical cases, toxicology for
including occasional fasciculations ial FTD accounting for approximately FTLD-TDP subtype associated with heavy metals, inflammatory biomark-
and mild muscle wasting or weak- one-third to half of cases.1 Most cases TDP-43; or FET protein accumula- ers for autoimmune and paraneoplas-
ness. As the disease evolves, the clin- of familial FTD present as the bvFTD tion.10 The FTLD-τ variant accounts tic syndromes, and testing for infec-
ical presentation of the 3 variants variant. A family history of dementia is for approximately 40% of all FTD tious etiologies including syphilis and
overlap with each other and with syn- found in 25% to 50% of FTD cases, cases. Approximately half the post- HIV should be considered.
dromes of atypical parkinsonism, in- and about 10% have a clear autosomal- mortem cases of FTD have abnormal Neuroimaging studies including
cluding progressive supranuclear dominant inheritance.9 Mutations in deposition of transactive response magnetic resonance imaging (MRI),
palsy (PSP) and corticobasal degen- the microtubule-associated protein tau DNA-binding protein 43 (TDP-43). functional magnetic resonance imag-
eration syndrome (CBS).8 (τ), progranulin, and chromosome 9 ing (fMRI), and single photon emis-
Compared with AD, patients with open reading frame 72 expansion are Diagnosis sion computed tomography (SPECT)
FTD tend to have a shorter duration the most common causes of familial FTD may be misdiagnosed as other scans can also assist in diagnosing
of survival from diagnosis and more FTD. These mutations result in the psychiatric disorders, including schizo- FTD. Table 3 describes the neuroim-
rapid decline of cognition and func- variable clinical presentations of FTD. phrenia, bipolar disorder, depression, aging findings in FTD.12 Cerebrospi-
tion.3 The average survival time with The major variants of FTD are or obsessive-compulsive disorder.2 The nal fluid (CSF) assessment will help
FTD depends on the subtype; the av- classified based on their respective bvFTD variant is most likely to be mis- rule out AD when the patient has low
erage survival time is approximately protein-based inclusions and underdiagnosed as another psychiatric disor- β-amyloid concentrations and high τ
3 years for bvFTD and motor neuron lying molecular pathologies. 1 The der; FTD may be misdiagnosed as AD protein concentration. Neuropsycho-
disease and 12 years for with svPPA. current neuropathological classifica- or another type of dementia. Table 2 logical testing will help rule out other
tion allows most cases of FTD to be describes the differentiating clinical causes of cognitive and functional
Neurobiology placed into 1 of 3 broad molecular features of the dementias.11 changes. Table 4 provides neuropsy-
Current evidence indicates that FTD is subgroups: frontotemporal lobar de- Given the high risk for misdiagno- chological profiles of various types of
a highly heritable disorder, with famil- generation (FTLD)-τ subtype; the sis, suspected cases of FTD should be dementias.13 Among individuals with
Table 3. Neuroimaging Findings in FTD

Type of
bvFTD nfvPPA svPPA lvPPA
neuroimaging study
Volumetric MRI Atrophy in the frontal and  Atrophy occurs mainly in the left A
symmetric temporal lobe Early left temporoparietal and
temporal lobes, especially cerebral cortex, including the atrophy especially in the posterior cingulate atrophy
in the prefrontal cortex, inferior frontal gyrus, especially anterior and inferior regions,
anterior temporal regions, pars opercularis, dorsolateral with the most common
the insula, anterior prefrontal cortex, superior presentation being prominent
cingulate, striatum, and temporal gyrus, and insula left‐sided atrophy
thalamus  As the illness progresses, there T
he earliest changes include
is involvement in the ipsilateral the loss of grey matter in the
anterior frontal, lateral temporal, inferior temporal and fusiform
and anterior parietal lobes, and gyri, the temporal pole, and
the contralateral prefrontal and the parahippocampal and
temporal lobes, followed by the entorhinal cortex
involvement of caudate and
putamen bilaterally
Functional MRI Reduced connectivity in Reduced functional connectivity Reduced functional connectivity
the salience network: the in the frontal operculum, primary in the semantic network
frontal lobe, anterior and supplementary motor areas, involving the left anterior
cingulate, insula, and inferior parietal lobule temporal lobe, inferior and
amygdala, medial ventral regions of the temporal
thalamus, and ventral lobe, bilateral frontal cortex, left
striatum amygdala, hippocampus,
caudate, and occipital regions
18-fluorodeoxyglucose Hypometabolism in the Greater hypometabolism in the Temporal lobe hypometabolism Left frontotemporoparietal
PET and SPECT frontotemporal regions, left inferior frontal and superior with asymmetrical left hypometabolism, especially in
especially the orbitofrontal, temporal regions hemisphere involvement in the the lateral frontal and posterior‐
dorsolateral, and medial entorhinal and perirhinal cortex, lateral temporal lobes, caudate,
prefrontal cortex and inferior temporal poles, and posterior cingulate, and
anterior temporal poles amygdala precuneus regions
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October 2020 P S Y C H I ATR I C T I M E S 35
Neuropsychiatry w w w. p s y c h i a t r i c t i m e s . c o m
a family history of dementia, move- Table 4. Neuropsychological Profile: 4 Dementias

ment disorders, and/or psychotic dis- Cognitive domains bvFTD AD VD LBD
orders, genetic counseling and a
search for genes that cause FTD are Registration Variable deficit Significant deficit Mild deficit Significant deficit
both recommended.2 Retrieval Variable deficit Significant deficit Significant deficit Significant deficit
Recognition Variable deficit Significant deficit Mild deficit Significant deficit

Treatments
Currently there are no US Food and Attention and No deficit Significant deficit Significant deficit Significant deficit
Drug Administration (FDA) ap- concentration
proved disease-modifying drugs for Speech Fluent Fluent Fluent Fluent
the treatment of FTD.14 In a system-
atic review, Nardell and Tampi found Visuoperceptual None Variable None Significant deficit
impairment
a total of 9 randomized, controlled,
double-blinded clinical trials that Executive function Significant deficit Significant deficit Significant deficit Significant deficit
evaluated various drugs for the treat- Behavioral disturbances Significant Variable Variable Variable
ment of FTD.15 These included 2 tri-
als of the selective serotonin reuptake Motor signs/symptoms Variable None Variable Significant
inhibitor paroxetine, 1 trial of trazo-
done, 2 trials of stimulants (methyl-
Table 5. Pharmacotherapy for FTD
phenidate and dextroamphetamine), Drug class Efficacy AEs
1 trial of the acetylcholinesterase in- Acetylcholinesterase inhibitors None May worsen behavioral and motor symptoms
hibitor galantamine, 2 trials of the N-
methyl-d-aspartate (NMDA) antago- Antipsychotics Modest for some behavioral symptoms Worsens extrapyramidal symptoms,
nist memantine, and 1 trial of the None for cognitive symptoms worsens cognition, increases risk for
cerebrovascular AEs and death
neuropeptide oxytocin. The investi-
gators concluded that SSRIs, trazo- Dopaminergic drugs Modest for some behavioral symptoms Worsens cognitive functioning and/or
done, and the amphetamines may be None for cognitive symptoms behavioral symptoms
effective in reducing some behavior-
NMDA receptor antagonists None May worsen behavioral symptoms and/or
al symptoms. None of these medica- cognitive decline
tions, however, improved cognition
among individuals with FTD. Avail- SSRIs and trazodone Modest for some behavioral symptoms Gastrointestinal AEs
able data also indicated that these None for cognitive symptoms
medications were well tolerated.
5. Gorno-Tempini ML, Hillis AE, Weintraub S, et al.
The evidence for the use of anti- Available evidence indicates that symptoms with those of other common Classification of primary progressive aphasia and its
psychotics for the treatment of behav- nonpharmacological management neuropsychiatric disorders. Although variants. Neurology. 2011;76(11):1006-1014.
ioral symptoms in FTD comes mainly techniques are helpful among indi- there are no FDA-approved medica- 6. Leyton CE, Hodges JR. Towards a clearer definition
of logopenic progressive aphasia. Curr Neurol Neuro-
from case reports and uncontrolled viduals with FTD.18 These interventions for the treating FTD, some agents
sci Rep. 2013;13(11):396.
studies.16 In addition, the use of anti- tions include environmental ap- have shown modest efficacy in improv- 7. Burrell JR, Kiernan MC, Vucic S, Hodges JR. Motor
psychotics can worsen the risk of ex- proaches that assist individuals who ing behavioral but not cognitive symp- neuron dysfunction in frontotemporal demen-
trapyramidal adverse effects, to which struggle to accurately interpret, under- toms. Nonpharmacological techniques tia. Brain. 2011;134(pt 9):2582-2594.
8. Sivasathiaseelan H, Marshall CR, Agustus JL, et al.
individuals with FTD are especially stand, and react to their environment. can be beneficial in managing behav- Frontotemporal dementia: a clinical review. Semin
vulnerable. Furthermore, the boxed In addition, behavioral modification ioral symptoms. Many newer therapies Neurol. 2019;39(2):251-263.
warning for the risk for death with the techniques and providing familiar ac- are currently under trial, although their 9. Borroni B, Benussi A. Recent advances in under-
standing frontotemporal degeneration. F1000Res.
use of antipsychotics among individu- tivities appear to reduce different benefits are not yet certain.
2019;8:F1000 Faculty Rev-2098.
als with dementia holds true also for types of behaviors. Evidence indicates 10. Mackenzie IR, Neumann M. Molecular neuropa-
individuals with FTD. For the treat- that educational services and coping Dr Tampi is chairman, Department of thology of frontotemporal dementia: insights into
ment of behavioral symptoms in FTD, strategies that are focused on prob- Psychiatry & Behavioral Sciences, disease mechanisms from postmortem studies. J
the evidence for the use of anticonvul- lem-solving are effective in managing Cleveland Clinic Akron General, Akron, Neurochem. 2016;138(suppl 1):54-70.
OH; chief, Section for Geriatric 11. Darrow MD. A practical approach to dementia in
sants—including valproic acid, topi- behavioral symptoms and reduce Psychiatry, Cleveland Clinic, the outpatient primary care setting. Prim Care.
ramate, and carbamazepine—is lim- caregiver burden. The development of Cleveland, OH; and professor of medi-
2015;42(2):195-204.
12. Gordon E, Rohrer JD, Fox NC. Advances in neuro-
ited to case reports. Evidence indicates individualized regimens incorporat- cine, Cleveland Clinic Lerner College of imaging in frontotemporal dementia. J Neurochem.
that individuals with FTD and parkin- ing environmental and behavioral Medicine, Case Western Reserve 2016;138(suppl 1):193-210.
sonism often do not respond to dopa- strategies have been proven to be University, Cleveland, OH. Ms Tampi 13. Burrell JR, Piguet O. Lifting the veil: how to use
minergic drugs, including levodopa/ highly beneficial in assisting individu- is executive vice president, Diamond clinical neuropsychology to assess dementia. J Neu-
Healthcare, Richmond, VA. Dr Parish rol Neurosurg Psychiatry. 2015;86(11):1216-1224.
carbidopa, although some case reports als with FTD. The family caregivers 14. Liu M-N, Lau C-L, Lin C-P. Precision medicine for
is with the Behavioral Advisory Group,
indicate some benefits with these who use these strategies become more frontotemporal dementia. Front Psychiatry. 2019;10:75.
Strongsville, OH. The authors report
agents. Table 5 summarizes the phar- competent in managing patients’ chal- no conflicts of interest concerning the
15. Nardell M, Tampi RR. Pharmacological treatments
for frontotemporal dementias: a systematic review of
macotherapy for FTD.15,16 lenging behaviors. Speech therapy has subject matter of this article. randomized controlled trials. Am J Alzheimers Dis
Trials of τ aggregation inhibitors, been found to be beneficial among Other Demen. 2014;29(2):123-132.
τ acetylation inhibitors, anti-τ active individuals with PPA.19 REFERENCES 16. Tsai RM, Boxer AL. Therapy and clinical trials in
1. Young JJ, Lavakumar M, Tampi D, Balachandran S, frontotemporal dementia: past, present, and future. J
vaccine, anti-τ monoclonal antibod- Tampi RR. Frontotemporal dementia: latest evidence Neurochem. 2016;138 Suppl 1(Suppl 1):211-221.
ies, anti-human sortilin monoclonal Concluding thoughts and clinical implications. Ther Adv Psychopharmacol. 17. Panza F, Lozupone M, Seripa D, et al. Development of
antibody, microtubule-stabilizing The clinical syndrome of FTD is char- 2018;8(1):33-48. disease-modifying drugs for frontotemporal dementia
drugs, and progranulin expression acterized by executive dysfunction, 2. Bang J, Spina S, Miller BL. Frontotemporal demen- spectrum disorders. Nat Rev Neurol. 2020;16(4):213-228.
tia. Lancet. 2015;386(10004):1672-1682. 18. Barton C, Ketelle R, Merrilees J, Miller B. Non-
activators have been completed or are behavioral disturbances, and language 3. Bott NT, Radke A, Stephens ML, Kramer JH. Fronto- pharmacological management of behavioral symp-
currently in various phases of trials.17 impairment. FTD is often misdiag- temporal dementia: diagnosis, deficits and manage- toms in frontotemporal and other dementias. Curr
Unfortunately, available results indi- nosed or underdiagnosed due to the ment. Neurodegener Dis Manag. 2014;4(6):439-454. Neurol Neurosci Rep. 2016;16(2):14.
4. Rascovsky K, Hodges JR, Knopman D, et al. Sensitivity of 19. Tippett DC, Hillis AE, Tsapkini K. Treatment of pri-
cate that none of these drugs have yet heterogeneity of its clinical presenta-
revised diagnostic criteria for the behavioral variant of fron- mary progressive aphasia. Curr Treat Options Neurol.
been found to be beneficial. tion and the overlap of its clinical totemporal dementia. Brain. 2011;134(pt 9):2456-2477. 2015;17(8):362. ❒
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36
Addiction & Substance Disorders

october 2020 w w w. p s y c h i a t r i c t i m e s . c o m
COMMENTARY
The Case for Medication-Assisted
Treatment: An Ethical Priority
» Kultaj Kaleka, RN, and Juliette In line with the goal of reducing
recidivism, a proportion of the crimi-
apparent through lenses of health
care as a source of harm, paternalism,
chological withdrawal symptoms
that they could easily avoid with
M. Perzhinsky, MD, MSc nal justice population is often divert- and violation of rights; through a re- MAT, including nausea, vomiting,
S
ubstance use disorder (SUD), ed to drug courts. According to fusal to provide access to appropriate diarrhea, agitation, anxiety, and sui-
including opioid use disorder SAMHSA, there are currently 2700 care; or through the intersection of cidality.3 This lack of access to ap-
(OUD), affects a significant operational drug courts in the United medicine and epidemiology. These proved and indicated therapy for a
proportion of the American popula- States.1 These courts adjudicate cas- considerations include issues around disease process could be construed as
tion—20.3 million (7.4%) of Ameri- es involving substance-involved of- access to MAT and the context in a punitive measure and borderline
cans aged 12 years or older had a fenders, or individuals who were ar- which consent to MAT is obtained cruel and unusual punishment. In
SUD in the past year.1 Of these, 2 rested for a drug-related offense and/ from those to whom it is offered. fact, detoxification in the absence of
million people had an OUD from or are eligible to enter a drug court MAT is an approved treatment for MAT is less efficacious than MAT
heroin and/or misuse of prescription program. Typically, an offender is OUD by the US Food and Drug Ad- and harmful to human health.4
pain relievers. Although medication- followed by a drug court for 12 to 18 ministration. The underlying phar- Surveys of drug courts and the US
assisted treatment (MAT) with meth- months. The National Drug Court In- macology of drugs used in MAT and prison systems do find practical rea-
adone, buprenorphine, or naltrexone stitute reports that more than 116,000 their physiological effects on indi- sons for not providing MAT, namely,
for OUD is the most efficacious, evi- criminal offenders were served by a viduals are well understood. MAT is the cost and lack of access to local
denced-based treatment that is rec- drug court program in 2009.4 How- known to assist in diminishing crav- providers. However, there are courts
ommended by the National Institute ever, only 56% of drug courts offer ings, and some agents can alleviate that do not permit MAT because of a
of Health, Substance Abuse and MAT to participants.5 Additionally, the withdrawal symptoms associated lack of knowledge and stigma around
Mental Health Services Administra- most individuals with SUD do not with OUD. However, many drug OUD. Many drug court teams are un-
tion (SAMHSA), and the World receive treatment while they are in- courts and prison facilities do not af- certain about the underlying physio-
Health Organization, only 11% of carcerated, or they are forced to with- ford provisions for MAT for incarcer- logical mechanisms of opioid recep-
patients with an OUD are prescribed draw from treatment they were re- ated individuals.2,5 tor agonists used in MAT and their
approved treatment. ceiving before incarceration In the absence of MAT, individu- efficacy in treating OUD. Some report
Limited access to MAT has been (Figure).2 als with OUD are forced to undergo they believe that patients with OUD
cited as a substantial barrier for pa- Ethical considerations around detoxification with full exposure to use MAT to get high and not for treat-
tients with OUD; inequities across MAT in caring for these patients are the negative physiological and psy- ment of OUD.4 Further, others think
ethnic and sociodemographic groups
speak to the health disparities evident
Figure. Availability of Medication-Assisted Treatment Within the Criminal Justice System
in society. The provision of appropri-
ate treatment and lack thereof are IN JAILS & PRISONS IN DRUG COURTS
even more troublesome when consid-
30 OUT OF 5,100
ering the vulnerable populations that In a 2018 study, participants with OUDs
bear the disproportionate burden of
SUDs and OUDs—namely, those in- prisons and jails in the U.S. offered
were 80% less likely
to graduate from drug court
volved with the corrections system methadone or buprenorphine in 2017
and those with serious mental illness Approximately 50% of drug courts required participants to discontinue
(SMI). It is no secret that a significant methadone or buprenorphine within 30 days in a 2017 study
proportion of the criminal justice 14 states offered methadone or buprenorphine maintenance
population has an SUD.1,2 for jail or prison inmates in 2018 < 50% OF DRUG COURT PARTICIPANTS
with OUDs received MAT in a 2018 study
Justice in criminal justice
Between 62% and 86% of individu- UPON REENTRY OR COMMUNITY CORRECTIONS
als arrested test positive for recent
45%
drug use,3 and 64% to 76% of arrest- Without MAT, there was a
ees meet diagnostic criteria for SUD.
29% of state and federal prisons
More than half of individuals with a IN THE U.S. PROVIDED REFERRALS FOR of state and federal prisons in the U.S. 10-40X HIGHER RISK
prescription OUD or heroin use in COMMUNITY BUPRENORPHINE PROVIDERS IN 2009 referred inmates for methadone of death from overdose within 2 weeks
of release from prison in a 2018 study
the past year report contact with the maintenance after release in 2009
criminal justice system.2 Similarly,
<5% of persons with OUDs referred to treatment in 2014 by probation, parole or court authorities
in terms of mental illness, 9.2 million received methadone or buprenorphine compared to 41% referred by non-criminal justice sources
Americans over 18 years old, or 3.7%
of American adults, had co-occurring Source: SAMHSA. Use of Medication-Assisted Treatment for Opioid Use Disorder in Criminal Justice Settings.
SUD and any mental illness in 2018.1 https://store.samhsa.gov/sites/default/files/d7/priv/pep19-matusecjs.pdf
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october 2020 Addiction & Substance P S Y C H I ATR I C T I M E S 37
Disorders w w w. p s y c h i a t r i c t i m e s . c o m
that MAT use for OUD is essentially be voluntary and free of coercion.6,7 It forded subpar and borderline unethi- REFERENCES
1. Key Substance Use and Mental Health Indicators in
replacing one addictive substance should be obtained from someone cal care. The underlying reasons be- the United States: Results From the 2018 National Sur-
with another.4 with the capacity to make a decision hind this unsettling phenomenon is a vey on Drug Use and Health. (HHS Publication No.
The false narrative that MAT rein- after they have an understanding of lack of health literacy around MAT PEP195068, NSDUH Series H54). Rockville, MD: Cen-
forces addiction or replaces an illicit the risks and benefits of available op- and stigma associated with OUD in ter for Behavioral Health Statistics and Quality, Sub-
stance Abuse and Mental Health Services Administra-
substance (heroin) has a negative im- tions. Consent under the threat of in- nonclinical settings. tion. 2019. Accessed September 10, 2020. https://
pact on individuals.3 Additionally, carceration, or while incapacitated, is store.samhsa.gov/product/key-substance-use-and-
the intersection of medicine and epi- not informed consent and compro- Concluding thoughts mental-health-indicators-in-the-united-states-re-
demiology is evident when those mises individual autonomy.6,7 An ethical framework is needed, as sults-from-the-2018-national-survey-on-Drug-Use-
and-Health/PEP19-5068
with SUDs/OUDs who do not have Many individuals with OUDs/ well as best practice guidelines high- 2. Winkelman TN, Chang VW, Binswanger IA. Health,
access to MAT turn to unsafe prac- SUDs choose Narcotics Anonymous, lighting the efficacy of and science polysubstance use, and criminal justice involvement
tices, such as the use of unclean nee- peer support, drug-free toxification, or behind MAT specifically directed at among adults with varying levels of opioid use. JAMA
dles to inject impure heroin or heroin treatment modalities other than MAT.3 the correctional system. Addressing Network Open. 2018;1(3).
3. Ludwig AS, Peters RH. Medication-assisted treatment
laced with synthetic fentanyl. This, in Assuming a binary disposition, MAT limitations in knowledge base and for opioid use disorders in correctional settings: An eth-
turn, leads to increased morbidity versus drug-free detoxification is highlighting shortcomings in protect- ics review. Int J Drug Policy. 2014;25(6):1041-1046.
and mortality as well as to public overly punitive and a violation of vol- ing the rights of incarcerated indi- 4. Matusow H, Dickman SL, Rich JD, et al. Medication
health issues of increased transmis- untariness and self-determination of viduals are both essential, in partner- assisted treatment in US drug courts: Results from a
nationwide survey of availability, barriers and atti-
sion of infectious diseases.3 these individuals. ship with all stakeholders (including tudes. J Subst Abuse Treat. 2013;44(5):473-480.
Patients with SUDs/OUDs often incarcerated patients, rights groups, 5. Substance Abuse and Mental Health Services Ad-
The dangers of coercion contend with unfavorable correction- judges, the correctional system, and ministration. Adult Drug Courts and Medication-As-
The other side of the coin: being pro- al system interactions as well as SMI, medical bodies). sisted Treatment for Opioid Dependence. In Brief.
2014;8(1). Accessed September 10, 2020. https://
cessed by a drug court and given the and they predominantly comprise store.samhsa.gov/product/Adult-Drug-Courts-and-
option of either incarceration or MAT. minorities from low-income or lim- Mr Kaleka is a fourth-year medical Medication-Assisted-Treatment-for-Opioid-Depen-
Asking an individual with a mentally ited educational backgrounds and student at Central Michigan University dence/sma14-4852
incapacitating illness to consent to with reduced social support. They are College of Medicine, Saginaw, MI. 6. D’Hotman D, Pugh, J, Douglas T. When is coercive
methadone therapy justified? Bioethics. 2018;
treatment brings in to question au- a vulnerable population whom soci- Dr Perzhinsky is an associate profes- 32(7):405-413.
tonomy and validity of consent. In- ety has largely marginalized.2 Their sor of medicine at Central Michigan 7. Beauchamp TL, Childress JF. Principles of Bio-
formed consent, by definition, should rights are threatened, and they are af- University College of Medicine. medical Ethics. Oxford University Press; 2019. ❒
COMMENTARY
Behind Closed Doors
» Omar Reda, MD can Muslim, strengthening fami- It became the norm to talk with munity, it may be about the immigra-
ly ties, and improving the relationship kids about their identity and self- tion system. In the Muslim commu-
N
ot only in America, but through- between the community and its neigh- worth, about micro- and macro-ag- nity, it may be about terrorism. Hate
out the world, difficult conver- bors and law enforcement agencies. gressions, about speaking up on be- is horrible, and it not only makes sur-
sations are taking place in many Fast forward to 2011, a bloody h a l f o f t h e vo i c e l e s s , bu t vivors doubt their own beauty, but it
homes. Behind closed doors, children civil war started in my home country also about how they can defend also makes us miss out on each oth-
are exposed at early ages to discus- Libya. I left my small immediate themselves when someone decides to er’s beauty.
sions about heavy topics like violence, family behind to care for my extend- attack them verbally or physically. We thought COVID-19 was only
hate, and human cruelty. ed family overseas, trying to he- After the Portland max train stabbing going to impact our ability to breathe,
I am blessed to have three daugh- al some of the many psychosocial incident and the New Zealand but then Mr Floyd’s death reminded
ters. I try to create a safe and wounds of that protracted conflict. I mosque shooting, we spent time and us of the ugly pandemic of oppres-
sane home for them, but I have never lost friends and loved ones to vio- energy brainstorming ways on how sion. In Oregon, the smoke of the
imagined engaging them in some of lence and extremism. My wife to stay alive and feel safe at our plac- wildfires stirs different discussions
these talks, especially here in the and children had to live through peri- es of social gatherings and worship. about existential themes, like our re-
United States, and in the 21st century. ods of uncertainty and high anxiety Trauma steals precious moments and lationship with God and the meaning
When I moved to Portland, Ore- every time I boarded a plane and par- impacts the potential for beauty. of life.
gon in 2009, I thought the city’s nick- took in that dangerous journey. I recently participated on a pan- Is it bad that our children are
name (the Rose City) was a sign that We thought and prayed the new el discussion about combating hate. growing up very quickly and having
things would be much safer and more decade would bring a better energy, A young black female stated that, “at these mature conversations at a
comfortable for my family. Similarly, but the year 2020 has been one of the least [things] are not as bad for this young tender age, or is that the new
my wife believed that moving from most challenging years of all. Here in generation as it was for our fellow norm? My hope is that trauma will
the southern to the northwestern part Oregon we have been struggling to citizens in the 1950s and 60s.” That eventually produce a more resilient
of the country would make things breathe, literally and metaphorically. really broke my heart. Just because generation and a more compassion-
easier for us as Muslims and people It is not only the threat of the corona- hate and violence are “not as bad,” ate and cohesive society. I believe
of color. virus disease 2019 (COVID-19) does not mean things are OK. Chil- that many trauma survivors be-
But shortly after arriving, a young to our respiratory system, but also the dren should not have to settle for a come better humans not despite, but
Somali boy was accused of planning systemic knee of injustice on the dysfunctional world. because, of their trauma stories.
a terrorist attack in one of the city’s necks of our black brothers and sis- “The talk” we thought we would
busiest spots, the Pioneer Square. We ters and the wave of hate facing mi- have with our children is about how Dr Reda is a practicing psychiatrist in
found ourselves working with com- norities and people of color. The to survive the emotional turmoil of Providence Healthcare System,
munity leaders and the Muslim youth mask can help with the former crisis, puberty. In the black community, Portland, OR. He reports no conflicts
on topics like emotional safety and but unmasking is what is needed for that talk is also about how to stay of interest concerning the subject
well-being, how to be a proud Ameri- the latter. alive in America. In the Latino com- matter of this article. ❒
PSY1020_036-037_Addiction-Kaleki.indd 37 9/30/20 8:44 AM

PREMIERE DATE: October 20, 2020
EXPIRATION DATE: April 20, 2022
This activity offers CE credits for:
1. Physicians (CME)
2. Other
October 2020
All other clinicians either will receive
a CME Attendance Certificate or
may choose any of the types of CE
credit being offered.
www.psychiatrictimes.com/cme EARN 30 FREE Category 1 CME Credits
Between Stoned and a Hard Place?

Navigating Cannabis Medicolegal Issues
Chandler Hicks, DO, Maria Lapchenko, DO, Adrienne Saxton, MD, and Sara West, MD
for her PTSD symptoms. Julia smoked marijuana The term cannabis refers to a genus of flower-
Dr Hicks is a PGY-2 psychiatry resident at Case Western occasionally during her early 20s and found it to ing plants belonging to the family cannabaceae.
Reserve University/University Hospitals in Cleveland, OH.
have a relaxing effect. She has not used marijuana Two common species—sativa and indica as well
Dr Lapchenko is medical director at Elwyn Natale in
since becoming pregnant with her first child about as their hybrids—are consumed in the United
Norristown, PA. Dr Saxton is an assistant professor of
8 years ago. She has many questions about medical States for medical and recreational purposes. A
psychiatry at Case Western Reserve University. Dr West
cannabis including its risks, benefits, and how to third rarer species, ruderalis, is endemic to Asia
is an associate professor of psychiatry at Case Western
Reserve University.
obtain it, and she is looking to you for advice. and Eastern Europe. The cannabis plant contains
approximately 500 known chemical compounds.
History of medical cannabis Sixty-six of these compounds are cannabinoids
“J
ulia” is a 31-year-old female with depres- The concept of cannabis as medicine has existed that are unique to cannabis; cannabinoids tetrahy-
sion and posttraumatic stress disorder for millenia,1 but its legal recognition has only be- drocannabinol (THC) and cannabidiol (CBD) are
(PTSD) who presents to your outpatient gun to gain traction with western medical practi- responsible for its psychoactive and purported me-
psychiatry clinic. She is married with 2 chil- tioners in the last 2 decades. California became the dicinal properties, respectively. The remainder of
dren and works as a store manager. Julia has been first state to legalize medical cannabis in 1996 the chemicals, such as nitrogenous compounds,
taking a selective serotonin reuptake inhibitor for with the passage of Proposition 215-Compassion- amino acids, and terpenes, can be found in other
the last 2 years, which alleviated her depressive ate Use Act, and many states have followed suit.2 plants and account for cannabis’ non-psychoactive
symptoms. However, Julia continues to experi- As of May 2020, all but 3 states (Idaho, South Da- properties including its color, flavor, and odor.5
ence PTSD symptoms including nightmares, kota, and Nebraska) have enacted legislation re- Although there are 3 main species of the canna-
flashbacks, and avoidant behavior. She has tried garding the use of either medical cannabis or can- bis plant, nearly 800 cultivars or strains are believed
various augmenting agents with little relief; she nabis-derived (ie, cannabidiol-containing) to exist.6 Cultivars are often described in terms of
currently engages in therapy. products (Figure).3 This trend mirrors the world- their cannabinoid content and specifically their
A friend of Julia’s recently told her that medical wide trend of increasing acceptance of medical CBD-to-THC ratios, as these account for their ad-
marijuana has been a panacea and has made it cannabis. Mexico, Australia, and much of Western vertised medicinal properties. High CBD-to-THC
much easier to function. Intrigued, Julia researched Europe and South America have legalized medical strains are believed to have anti-inflammatory and
cannabis online and found it might be beneficial cannabis.4 calming properties; they are thought to be effective
ACTIVITY GOAL ACCREDITATION/CREDIT DESIGNATION/FINANCIAL a specific patient’s medical condition.

The goal of this activity is to explore the medicolegal SUPPORT
This activity has been planned and implemented in accordance with The opinions expressed in the content are solely those of the individ-
aspects of medical marijuana.
the accreditation requirements and policies of the Accreditation ual faculty members and do not reflect those of Physicians’ Education
LEARNING OBJECTIVES Council for Continuing Medical Education (ACCME) through the joint Resource®, LLC.
After engaging with the content of this CME activity, you should be providership Physicians’ Education Resource®, LLC and Psychiatric FACULTY, STAFF, AND PLANNERS’ DISCLOSURES
better prepared to: Times. Physicians’ Education Resource®, LLC is accredited by the The authors, James L Knoll IV, MD, (external peer reviewer), and the
• Understand the basic concepts of medical marijuana including its ACCME to provide continuing medical education for physicians staff members of Physicians’ Education Resource®, LLC and Psychi-
history and legislation. Physicians’ Education Resource®, LLC designates this enduring atric Times have no relevant financial relationships with commercial
• Review possible indications and potential side effects of medical material for a maximum of 1.5 AMA PRA Category 1 Credits™. Phy- interests.
marijuana with patients. sicians should claim only the credit commensurate with the extent of For content-related questions email us at PTEditor@mmhgroup.
their participation in the activity. com; for questions concerning the accreditation of this CME activity
• Discuss the social barriers associated with medical marijuana use.
This activity is funded entirely by Physicians’ Education Resource®, or how to claim credit, please contact info@gotoper.com and include
• Understand the potential areas of liability physicians may encounter
LLC. No commercial support was received. Between Stoned and a Hard Place? Navigating Cannabis Medicolegal
surrounding medical marijuana.
Issues in the subject line.
OFF-LABEL DISCLOSURE/DISCLAIMER
TARGET AUDIENCE HOW TO CLAIM CREDIT
This CME activity may or may not discuss investigational, unap-
This continuing medical education (CME) activity is intended for Once you have read the article, please use the following URL to
proved, or off-label use of drugs. Participants are advised to consult
psychiatrists, psychologists, primary care physicians, physician as- evaluate and request credit https://education.gotoper.com/activity/
prescribing information for any products discussed. The information
sistants, nurse practitioners, and other health care professionals who ptcme20october. If you do not already have an account with PER®
provided in this CME activity is for continuing medical education pur-
seek to improve their care for patients with mental health disorders. poses only and is not meant to substitute for the independent clinical you will be prompted to create one. You must have an account to
judgment of a physician relative to diagnostic or treatment options for evaluate and request credit for this activity.
PSY1020_038-042_CME.indd 38 9/30/20 8:26 AM

October 2020 PSYCHIATRIC TIMES 39
CME
Figure. Legality of Cannabis in the United States House Judiciary Committee, but Congress has not
yet voted on it.12,13 If passed, the MORE Act would
be another significant victory because scientists
could apply for federal funds to formally research
D = Decriminalized the potential medical benefits of cannabis.
D Presently, as there is no federal legislation legit-
D D imizing its use, medical cannabis laws have been
D crafted at the discretion of individual states.14 As a
D result, there is significant variation from state to
D
D state (Table 1). Given the significant variation in
D D
medical cannabis laws amongst states and the con-
D
D tinually shifting legal landscape regarding its use,
D
medical cannabis presents a unique challenge for
D medical professionals who consider recommend-
D ing it to their patients or who treat patients who
receive it from other professionals. It is important
D
that clinicians familiarize themselves with state
laws to ensure compliance since deviation can have
serious consequences for their licensure.
D Indications
Marijuana has long been a part of popular culture.
When smoked, vaped, or ingested, THC can pro-
Legal Legal for medical use Legal for medical use, limited THC content Prohibited for any use duce sought-after effects such as euphoria, height-
ened senses, a distorted sense of time, alterations
Source: Lokal_Profil https://creativecommons.org/licenses/by-sa/2.5/;
https://en.wikipedia.org/wiki/Legality_of_cannabis_by_U.S._jurisdiction#/media/File:Map_of_US_state_cannabis_laws.svg in physical movements, and decreased inhibitions.
With 38 states allowing for the use of THC-con-
for the treatment of autoimmune, mood, and anxiety public interest and threatened to revoke the pre- taining medical marijuana compounds (Figure), it
disorders. In contrast, high THC-to-CBD strains are scribing privileges of those physicians who did not stands to reason that it may be effective for treat-
advertised as being helpful for pain and nausea.7 comply with the policy.9 The 1996 federal policy ing physical and mental ailments. By far, the most
(These statements have not been evaluated by the led to a landmark legal case Conant v Walters common psychiatric diagnosis listed by these
US Food and Drug Administration. The FDA has (United States Court of Appeals for the Ninth Cir- states is PTSD, but others include Tourette syn-
not approved a marketing application for cannabis cuit, 2002). The class action lawsuit was filed by drome, Alzheimer, and autism. As psychiatrists,
due to its federally illegal status and classification as patients with seriously medical illness and their we may be approached to diagnose some of these
a Schedule I drug.) doctors against John P. Walters, director of the conditions in our patients as part of their interest in
White House Office of National Drug Control Pol- obtaining medical marijuana.
Legislation icy and others. The court ultimately ruled that the
Laws governing cannabis cultivation and use have existing federal policy violated a physician’s first Adverse effects
not always been so favorable. While cannabis was amendment right to free speech by threatening cen- It is important to consider what can go wrong
a popular ingredient in medicinal compounds tout- sure for discussions held in the sanctity of the doc- when using THC. Common short-term side effects
ed as a cure for a variety of conditions (eg, gonor- tor-patient relationship; it further found physicians include conjunctival injection (often a tell-tale
rhea and “childbirth psychosis” in the late 19th may discuss the pros and cons of medical marijua- sign of intoxication), hyperphagia (or, in common
and early 20th centuries), laws limiting and pro- na with their patients and issue oral or written opin- parlance, “the munchies”), xerostomia “cotton-
hibiting its use were enacted as early as the 1920s. ions recommending its use. However, the court mouth,” dyspnea, tachycardia, and slowed motor
By 1931, 29 states passed legislation explicitly explicitly stated that physicians may not prescribe response leading to delayed reaction time (which
barring possession of cannabis. In the decades that or dispense marijuana or “aid and abet” the patient is particularly concerning while driving or operat-
followed, there were harsher penalties for posses- in the purchase, cultivation, or possession of mari- ing heavy machinery). One of the most common
sion, including mandatory minimum sentences for juana. This landmark decision was the first to out- psychiatric side effects is paranoia; this may be
charges of possession of cannabis. line a physician’s right to recommend, but not pre- worth noting when discussing marijuana with pa-
In 1971, the Controlled Substances Act (CSA) scribe, cannabis and provided a basis for legal tients who have a history of paranoid beliefs.
created the Drug Enforcement Agency’s drug sched- protection from sanctions against their license.10 There are also long-term issues that have been
ules that still exists today. The CSA placed cannabis In 2014, Congress passed the Rohrabacher-Farr associated with THC. These may include cannabi-
in the Schedule I category of drugs along with hero- amendment as part of Commerce, Justice, Sci- noid hyperemesis syndrome/cyclic vomiting syn-
in, LSD, ecstasy, and psilocybin, all of which are ence, and Related Agencies Appropriations Act. drome and amotivational syndrome.16 There are
believed to have no current medical use, high abuse This amendment, initially introduced in 2001, pro- potential consequences in pregnant woman, in-
potential, and lack of accepted safety data for use hibits the use of federal funds to interfere with the cluding a negative impact on fetal brain develop-
under medical supervision.8 The CSA dealt perhaps implementation of state medical cannabis laws. ment and decreased birth weight.17 Finally, some
the hardest blow to cannabis’ potential use as a ther- The Rohrabacher-Farr amendment is considered a argue that marijuana serves as a gateway drug,
apeutic agent by prohibiting the use of federal funds significant victory for proponents and consumers placing users in circumstances where they find
for any research into its efficacy and safety. of medical cannabis because it allows state medi- themselves compelled to use more dangerous
DENYS HOLOVATIUK@STOCK.ADOBE.COM
Cannabis legislation remained at a standstill for cal cannabis dispensaries to operate without fear drugs with a higher potential for addiction.
25 years after the CSA until the passage of Propo- of prosecution by the federal government, which Doctors may also be called upon to answer
sition 215 in California, which allowed patients still considers cannabis to be illegal due to its clas- questions about CBD. As it is readily available in
with a valid doctor’s recommendation to possess sification as a Schedule I drug.11 multiple forms (eg, gummies, oils, pills) at numer-
and cultivate cannabis for personal use. In direct Legislation to reclassify cannabis from a Sched- ous locations (eg, pharmacies, health food stores,
response to the proposition’s passage, the federal ule I to a Schedule III drug and decriminalize it at gas stations), one may conclude that it is relatively
government also issued a policy in 1996 indicating a federal level was introduced in the Marijuana Op- benign. The FDA, however, warns that CBD may
that a physician’s recommendation or prescription portunity, Reinvestment, and Expungement cause somnolence, gastrointestinal distress, irrita-
of Schedule I substances was not in line with the (MORE) Act of 2019. The Act was passed by the bility, and/or agitation.18 Regarding its efficacy as
PSY1020_038-042_CME.indd 39 9/30/20 8:26 AM

40 PSYCHIATRIC TIMES October 2020
CME
a treatment option for serious mental illness, the Employment restrictions are delineated at the require employers to reasonably accommodate an
results appear inconclusive.19,20 state level with varying degrees of stringency. The employee’s medical needs for off-duty/off-sight
There is much discussion regarding the rela- exception is federal employees who are prohibited use.26,27 This could entail allowing the employee to
tionship between marijuana and psychosis, as from using both medical and recreational marijua- work shifts that do not interfere with medical mari-
there is some overlap between cannabis intoxica- na. The medical cannabis laws of Nevada and juana use. Since on-duty use and related impair-
tion and primary psychotic disorders. For those Washington will be used for illustrative purposes ment are prohibited, employers may implement
experiencing a psychotic episode with concomi- due to their contrasting laws. However, each state policies to determine impairment in a variety of
tant marijuana use, the etiology of the symptoms has slight nuances that need to be reviewed before different ways. For example, suspected impairment
becomes complex. If a patient who uses marijuana discussing medical marijuana with patients. may be confirmed with a drug screen or via obser-
is later diagnosed with schizophrenia, the marijua- The pre-employment job process may involve vation of behavioral changes. However, for chronic
na can further complicate the picture. For instance, a drug screen and/or a questionnaire inquiring medical marijuana users, a drug screen is likely to
in their resistance to accept the schizophrenia di- about marijuana (medical or recreational) use. The be a poor indicator of impairment, as the non-psy-
agnosis, the patient and family may prefer to attri- employer, according to their own policies, must choactive components of marijuana can stay in the
bute the psychotic symptoms to marijuana. Unfor- choose how to handle a positive drug screen. Some body for weeks.28 The state of Arkansas recognized
tunately, this may lead to delays in receiving the may recognize medical marijuana as a legitimate this issue and ruled that an employer cannot use a drug
appropriate antipsychotic treatment. treatment and disregard a positive test. Others may test as the sole indicator of impairment.29 Other states
According to a 2016 meta-analysis, increased have a zero-tolerance drug policy. have allowed the employer autonomy over the
exposure to THC increases the odds of being diag- A zero-tolerance policy was unsuccessfully methodology of determining impairment. Regard-
nosed with schizophrenia.21 Additionally, THC use challenged by a Washington state employer in Roe ing off-duty use, restrictions are again variable.
is associated with poor medication response, med- v Teletech (Washington Supreme Court, 2011). Some states force employers to recognize medical
ication noncompliance, and higher frequency and The Washington Supreme Court upheld a ruling marijuana status, while others do not.30
temporary worsening of psychotic symptoms.22,23 that an employer does not have to accommodate
This information should be tempered when dis- an employee’s use of medical marijuana, even Driving
cussing marijuana use with patients; while a clini- when the employee is in a non-safety-sensitive po- Similar to employment, states have struggled with
cian may share concerns about marijuana use with sition and uses medical marijuana exclusively off- issues regarding people who use medical marijuana
their patients, an absolute intolerance could poten- site.24 In contrast, Nevada recognized the quandary and drive due to the difficulty of identifying suspect-
tially damage the therapeutic alliance. of allowing medical marijuana while simultane- ed impairment and corroborating it with objective
ously permitting employers to discriminate against measures that will hold up in court. Currently, there
Employment its use. Thus, Assembly Bill 132 was passed, mak- are 4 main testing methods: urine, blood, saliva, and
After reviewing Julia’s medical history and dis- ing Nevada the first state to prohibit employers breathalyzer. While urine and blood are the most
cussing the potential side effects of medical mari- from discriminating against applicants for a posi- commonly employed testing methods, they are also
juana, Julia begins to share concerns over the use tive marijuana test.25 It should be noted that some the poorest measures of impairment. Depending on
of medical marijuana for her PTSD. She asks jobs are exempt from the Nevada bill. the amount, frequency, and mode of marijuana use,
about anticipated employer problems, but she is Once employed, on-duty use of medical mari- THC may be metabolized by the liver within hours
unaware of her workplace’s policies. Julia further juana is almost universally prohibited. However, of ingestion.28 However, the nonpsychoactive metab-
questions how it may affect other facets of her life. some states (eg, Massachusetts and Nevada) may olites can remain in the system for weeks. A problem
with generic urine and drug tests is that they do not
evaluate for psychoactive versus nonpsychoactive
Table 1. Areas of State-by-State Variation in Medical Cannabis Laws metabolites. Rather, they only test for the presence of
Qualifying conditions: Most states outline qualifying conditions, but a minority allow physicians cannabinoids, which may be present for hours to
Diagnosable medical to use their discretion about constitutes such. weeks depending on the chemical compound. Thus,
conditions that qualify  Most common: Severe, life-limiting illness such as cancer, HIV/AIDS, someone could ingest medical marijuana, have mul-
a patient to use medical movement disorders/multiple sclerosis, amyotrophic lateral sclerosis, tiple days go by where they are no longer actively
cannabis seizure disorders, and terminal illness. intoxicated, but still test positive on a drug or urine
 Psychiatric illnesses: PTSD, Tourette disorder, and autism test. This is currently the case in Pennsylvania where
 Neuropsychiatric disorders: Parkinson disease, Alzheimer disease, a person using medical marijuana can be automati-
traumatic brain injury, and Huntington disease cally issued a driving under intoxication notice after
Approved recommenders In most states, only physicians can make a medical cannabis a crash if they fail a drug test.31
recommendation. However, several states allow nurse practitioners and Some states have recognized this conundrum
physician assistants to recommend medical cannabis. and sought alternative testing methods. The breath-
Some states require recommenders to complete an online training course,
alyzer is a method being explored.32 A saliva test,
Recommender training
while others only require that recommenders have an active DEA license. which is currently being used in Europe, Alabama,
and Oklahoma, is also being investigated as an op-
Home cultivation of Most states do not allow home cultivation of medical cannabis, except for tion. However, the issue remains that neither test
medical cannabis 7 states and Washington, DC. Some states only allow home cultivation
can determine impairment as there is no universal
under certain circumstances (eg, if a patient lives too far from a
dispensary); there are generally quantity limits on the number of plants
standard. Arizona and Michigan have remedied
that can be grown. this issue by ruling that a positive blood or urine
test alone is not sufficient evidence to prove intox-
Formulation While cannabis is available in numerous formulations, including edibles, ication.31 Therefore, the burden of proof is on the
oils, smokable herb, tinctures, sprays, and topicals (eg, lotion, salve, etc),
police officer alleging that a driver was intoxicated.
some states explicitly prohibit some formulations for medicinal purposes.
For example, several states prohibit smoking of the dried herb.
Gun ownership
Possession quantities Some states indicate a specific quantity of dried herb or oil that a patient Under the Gun Control Act of 1968, any unlawful
can possess at any one time, while others allow a patient to possess the user of a controlled substance is prohibited from
quantity they use in a specific timeframe (usually 1-3 months).
purchasing or owning a gun.33 The key words at
Chemical composition About one-half of all states that have legalized medicinal cannabis have issue are “controlled substance.” Since marijuana
restrictions on the percentage of THC, excluding those states with is classified as a Schedule I controlled substance, it
legalized recreational use. In those states that allow only “low THC” is illegal for anyone who uses medical marijuana to
formulations, THC percentage limits range from 0.3-5%.15
purchase a gun.34 Gun shops screen for marijuana
PSY1020_038-042_CME.indd 40 9/30/20 8:26 AM

October 2020 PSYCHIATRIC TIMES 41
CME
use with the Federal Bureau of Alcohol, Tobacco, Table 2. How To Reduce Risk in a Medical Marijuana Practice50
Firearms and Explosives form 4473, which serves
1. Familiarize yourself with professional guidelines for medical marijuana recommendations. (Eg,
as a document to determine eligibility and record Federation of State Medical Boards. Model guidelines for the recommendation of marijuana in
transactions.35 patient care. April 2016)
2. Review the state law regarding medical marijuana recommendations in your state and follow the
Travel requirements closely.
Depending on the patient, travel may be another 3. Establish a genuine physician-patient relationship prior to certifying medical marijuana.
barrier to treatment and complication. Crossing 4. Collect a detailed history, examine the patient, and review past records. Pay attention to personal or
state lines with medical marijuana is a precarious family history of psychosis or substance use disorders.
venture and could lead to harsh legal consequences. 5. Consider additional diagnostic tests or outside consultation, if needed.
Some states offer reciprocity laws that recognize 6. Establish a diagnosis and consider whether it is a qualifying condition for medical marijuana in your
out-of-state medical marijuana documents, while state. Even if it is a qualifying condition, weigh the risks vs benefits of medical marijuana treatment
others do not. If traveling by plane, Transportation with the patient.
Security Authors officers reserve the right to report 7. Utilize a detailed written informed consent and treatment agreement. This should include a review of
individuals who are carrying marijuana (regardless potential side effects associated with cannabis; education about lack of FDA approval and
regulation of cannabis products; risks of: driving while under the influence, developing a cannabis
of medical status) to local, state, or federal author-
use disorder, psychosis and cognitive side effects; risks in pregnancy and breastfeeding; and the
ities.36 In addition, airlines have their own policies need to safeguard cannabis products from children and pets.
that may restrict cannabis onboard.37 8. Check the patient’s state prescription drug monitoring program prior to each recommendation for
marijuana.
Education 9. Maintain accurate and complete records. Update the state marijuana registry appropriately.
Finally, due to the difference between state and 10. Schedule follow-ups to monitor treatment progress at the minimum frequency required by state law.
federal laws, schools are left to make their own de- The duration of treatment should be no more than 12 months according to the FSMB guidelines.
cisions regarding medical marijuana use. Most 11. Avoid conflicts of interest. Physicians should not hold financial interest in marijuana dispensaries.
schools receive state and federal funding, leaving Note that accepting different fees for an assessment in which a marijuana certificate is granted
them with the difficult task of trying to balance versus declined can create a similar conflict of interest.
obeying laws that allow them to procure funding
and accommodating their students’ needs. In Okla- recommendation of medical marijuana treatment, statements by professional organizations to establish
homa, medical marijuana is legal. However, the the potential exists. Consider a patient who pres- the standard of care in a given scenario. Many profes-
University of Oklahoma ruled marijuana is prohib- ents seeking a marijuana card for chronic pain of sional medical and psychiatric associations do not
ited on campus, regardless of medical status.38 This 6 months duration. If the physician recommends presently recommend medical marijuana due to in-
has forced students who use medical marijuana to marijuana as a treatment, but fails to review past sufficient data, concern about negative effects, and
live off-campus and find alternative times of use. records, examine the patient, or consider diagnos- lack of regulation. This could bolster the plaintiff’s
tic studies to work up the pain complaint, there is argument that a physician’s recommendation of
Finances potential for a missed serious diagnosis underly- medical marijuana did not meet the standard of care.
In addition to the various social constraints, price ing the pain (eg, malignancy). An expert could
may be the ultimate decider of consumption. Med- argue that the physician deviated from the stan- Medical board discipline
ical marijuana tends to cost more than marijuana dard of care by failing to gather sufficient informa- In contrast to malpractice liability related to med-
procured for recreational use.39 Price is dependent tion and by failing to perform necessary diagnostic ical marijuana, which is mostly hypothetical at
on location, supply and demand, method of con- workup or referral, which resulted in delayed di- this point, there are several documented cases of
sumption, and THC content. The cost of an ounce of agnosis and proper treatment. Another example, medical board discipline against physicians rec-
medical cannabis in Colorado is well over $200 plus perhaps more relevant to psychiatry, involves a ommending medical marijuana. According to the
taxes compared to approximately $150 for medical physician who misses a diagnosis of schizophre- Federation of State Medical Boards (FSMB),
grade street cannabis.40,41 This could lead individu- nia in a patient (either due to failure to review re- 4081 physicians across the United States were dis-
als to pursue other methods for obtaining cannabis. cords, gather relevant history, or conduct a mental ciplined by state medical boards in 2017.42 This
status examination) and recommends medical represents less than 1% of physicians with active
Areas of risk for physicians marijuana to treat PTSD. Later, the treatment re- licenses (985,026), according to a 2018 census
At the conclusion of your appointment with Julia, sults in an exacerbation of psychosis that leads to conducted by the FSMB.43 To our knowledge, no
she decides that it may not be the most opportune violence toward self or others. In both examples, a analysis has been published regarding disciplinary
time to pursue medical marijuana, due largely to medical malpractice case would likely hinge on actions by state medical boards related specifical-
workplace concerns. She schedules a follow-up whether the doctor breached the standard of care. ly to medical marijuana.
appointment to discuss this again at a later time. It is important to keep in mind that although med- There are, however, several examples from news
After the meeting, you converse with colleagues ical marijuana is a legal treatment in a number of articles and case law. In 2016, for example, 4 doc-
about the potential liability associated with medi- states, legal is not synonymous with meeting the tors in Colorado had their licenses suspended for
cal marijuana from a physician perspective. standard of care. The legalization of medical canna- recommending excessive marijuana plant counts.44
Some physicians argue that the lack of data bis prohibits criminal prosecution of the physician At that time, the standard plant count was 6 per pa-
about the efficacy of marijuana for treating various for recommending medical marijuana provided the tient, yet these doctors approved 75 or more plants
conditions stems from the severe research limita- physician complies with the state-specific regula- for many patients. In 2017, a Michigan physician
tions that have lasted decades in the United States. tions regarding recommending medical cannabis. faced medical board discipline for certifying medi-
They would like to provide their patients with a Conversely, “standard of care” provides a benchmark cal marijuana without conducting a physical exam-
potentially helpful treatment recommendation, but with which to measure the conduct of the physician ination.45 After appealing the medical board deter-
they may be concerned about the possible risks. In in assessing for negligence in their medical manage- mination, the Michigan Court of Appeals upheld his
general, medicolegal risks associated with the ment. It is possible for a physician to prescribe a discipline, citing statements by American Society
practice of medicine can be divided into 3 broad medication that is not against the law but goes against of Addiction Medicine and Federation of State
categories: malpractice, disciplinary action by what an ordinary or reasonably prudent physician Medical Boards that recommend examining the pa-
state medical boards and, rarely, criminal charges. would prescribe in such circumstances (eg, haloper- tient prior to certifying medical marijuana. In 2019,
idol as first line treatment for childhood atten- a naturopath had his license suspended after recom-
Malpractice tion-deficit/hyperactivity disorder). Courts may seek mending marijuana cookies as a treatment for
Although there are no known cases in which a guidance from expert testimony, treatment guide- ADHD and bipolar disorder in a 4-year-old boy.46
physician was sued for malpractice related to their lines, journal articles, facility policies, and position In 2019, a physician in New Jersey lost his license
PSY1020_038-042_CME.indd 41 9/30/20 8:26 AM

42 PSYCHIATRIC TIMES October 2020
CME
for indiscriminately prescribing medical cannabis dia. Accessed September 12, 2020. https://ballotpedia.org/California_ 30. Barreiro S. State Laws on Off-Duty Marijuana Use. Accessed Sep-
Proposition_215,_the_Medical_Marijuana_Initiative_(1996). tember 13, 2020. https://www.nolo.com/legal-encyclopedia/state-
to patients at hotel conferences that he hosted. The 3. Cannabis in the United States. Wikipedia. Accessed September 12, laws-on-off-duty-marijuana-use.html#nevada
doctor was accused of failing to establish bona fide 2020. https://en.wikipedia.org/wiki/Cannabis_in_the_United_States 31. Sullum J. After a state-authorized medical marijuana patient had an
physician-patient relationships, gather comprehen- 4. The Legalization of Cannabis is Spreading Globally. Accessed Sep- epileptic seizure and crashed her car, police arrested her for driving with
sive histories and examine patients, assess patients’ tember 13, 2020. https://static.seekingalpha.com/uploads/2018/ ‘marijuana in her system.’ Reason. March 13, 2020. Accessed Septem-
11/49795830_15411931331022_rId7.jpg ber 13, 2020. https://reason.com/2020/03/13/after-a-state-authorized-
qualifying conditions every 3 months, and keep ac- 5. Elsohly S. Chemical Constituents of Cannabis. Cannabis and Canna- medical-marijuana-patient-had-an-epileptic-seizure-and-crashed-her-
curate and complete records.47 binoids: Pharmacology, Toxicology, and Therapeutic Potential. Psychol- car-police-arrested-her-for-driving-with-marjuana-in-her-system
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Criminal charges 6. Cannabis Strains: How Many Different Kinds Are There? Med Well. next steps. NPR. September 5, 2019. Accessed September 13, 2020.
September 13, 2020. https://www.medwellhealth.net/cannabis- https://www.npr.org/2019/09/05/757882048/scientists-un-
In addition to state medical board discipline, doctors strains-different-kinds/ veil-weed-breathalyzer-launching-debate-over-next-steps
have rarely faced criminal charges related to medi- 7. CBD:THC ratios: Maximizing your medicine. The Apothecarium. Jan- 33. Gun Control Act of 1968. 18 U.S.C. ch. 44 § 921. Accessed Septem-
cal cannabis certificates. In 2013, a Michigan doctor uary 26, 2018. Accessed September 13, 2020. https://apothecarium. ber 13, 2020. https://www.govinfo.gov/content/pkg/STATUTE-82/pdf/
was convicted of health care fraud for selling signed com/blog/nevada/2018/1/26/cbdthc-ratios-maximizing-your-medicine STATUTE-82-Pg1213-2.pdf
8. Blaszczak-Boxe A. marijuana’s history: how one plant spread through 34. United States Drug Enforcement Agency. The Controlled Substances
medical marijuana certificates to a middleman for the world. Live Science. October 17, 2014. Accessed September 13, Act. September 13, 2020. https://www.dea.gov/controlled-substances-act
resale.48 In 2016, the Arizona Supreme Court re- 2020. https://www.livescience.com/48337-marijuana-history-how- 35. US Department of Justice. Firearms Transaction Record. Accessed
viewed a case in which a physician was indicted on cannabis-travelled-world.html September 13, 2020. https://www.atf.gov/firearms/docs/4473-part-1-
forgery and fraudulent schemes related to allegedly 9. Several marijuana-related bills pending in Congress. The Marijuana firearms-transaction-record-over-counter-atf-form-53009/download.
Policy Project. January 13, 2020. Accessed September 13, 2020. 36. Transportation Security Administration. Medical Marijuana. Ac-
lying about reviewing a patient’s medical records https://www.mpp.org/policy/federal/ cessed September 13, 2020. https://www.tsa.gov/travel/securi-
when he certified her for medical marijuana.49 10. Conant v Walters, 309 F.3d 629, 9th Cir. 2002. ty-screening/whatcanibring/items/medical-marijuana
Although medical board discipline and crimi- 11. Swerdlow L. Why marijuana users need to beware the end of 37. Wolfe J. How to travel with medical marijuana. The New York Times.
nal charges related to marijuana certifications are Rohrabacher-Farr. Cannabis Cheri. January 22, 2017. December 31, 2019. Accessed September 13, 2020. https://www.ny-
12. Gunther A. Bill that would federally decriminalize marijuana passes times.com/2019/12/31/travel/traveling-with-medical-marijuana.html
likely rare, these situations can have serious and House committee. CBS News. November 21, 2019. Accessed September 13, 38. Cotten K. Medical marijuana policy prohibits use on campus, causes
long-lasting implications for a physician’s career. 2020. https://www.cbsnews.com/news/more-act-bill-that-would-federal- problem for students. OU Daily. February 6, 2019. Accessed September
Losing one’s medical license involves a loss of ly-decriminalize-marijuana-passes-house-committee-today-2019-11-20/ 13, 2020. http://www.oudaily.com/news/ou-s-medical-marijuana-pol-
one’s livelihood, source of income, and reputation. 13. Ahn J. Breaking News: MORE Act Passes in Historic Vote. Harris Bricken. icy-prohibits-use-on-campus-causes/article_596166b6-2a4a-11e9-
November 22, 2019. Accessed September 13, 2020. https://harrisbricken. b627-e79235e6cbce.html
Should a physician decide to establish a medical com/cannalawblog/breaking-news-more-act-passes-in-historic-vote/ 39. Shankar P. Cost of Ohio’s medical marijuana is still higher than street
marijuana practice, we recommend considering a 14. Qualifying conditions for medical marijuana by state. Leafly. January prices. Cleveland Scene. April 4, 2019. Accessed September 13, 2020.
number of steps to reduce risk (Table 2).50 29, 2020. Accessed September 13, 2020. https://www.leafly.com/news/ https://www.clevescene.com/scene-and-heard/archives/2019/04/04/
health/qualifying-conditions-for-medical-marijuana-by-state#alaska cost-of-ohios-medical-marijuana-is-still-higher-than-street-prices
15. Legality of Cannabis by U.S. Jurisdiction. Accessed September 13, 40. Council K. Differences between medical and recreational prices.
Concluding thoughts 2020.https://en.wikipedia.org/wiki/Legality_of_cannabis_by_U.S._ Leaf Buyer. July 9, 2019. Accessed September 13, 2020. https://www.
The use of marijuana, recreational or medical, has jurisdiction. leafbuyer.com/blog/differences-between-medical-recreational-prices/
long been part of society. There was hemp use in the 16. Sontineni SP, Chaudhary S, Sontineni V, et al. Cannabinoid hypereme- 41. Colorado Weed Prices. Budzu. Accessed September 13, 2020. http://
1600s, “Reefer Madness” in the early 1930s, the sis syndrome: Clinical diagnosis of an underrecognized manifestation of budzu.com/prices/usa/colorado
chronic cannabis abuse. World J Gastroenterol. 2009;15(10):1264-1266. 42. US Federation of State Medical Boards Medical Regulatory Trends
“peace and love” movement of 1960s, and today it 17. Thompson R, DeJong K, Lo J. Marijuana use in pregnancy: a review. and Actions 2018. December 3, 2018. Accessed September 13, 2020.
seems to be the catch-all treatment for various medi- Obstet Gynecol Surv. 2019;74(7):415-428. http://www.fsmb.org/siteassets/advocacy/publications/us-medi-
cal disorders. Throughout it all, the cultural impact of 18. US Food and Drug Administration. What you need to know (and what cal-regulatory-trends-actions.pdf
marijuana is undeniable. It is with this ever-evolving we’re working to find out) about products containing cannabis or can- 43. Young A, Chaudry H, Pei X, et al. FSMB census of licensed physicians
nabis derived compounds, including CBD. Accessed September 13, in the United States, 2018. J Med Regul. 2019;105(2):7-23.
relationship that states have increasingly changed 2020. https://www.fda.gov/consumers/consumer-updates/what-you- 44. Ingold J. Four Colorado doctors suspended over medical marijuana
legislation to reflect the latest societal attitudes, need-know-and-what-were-working-find-out-about-products-con- recommendations. The Denver Post. Published July 19, 2016. Updated
which currently consist of increasing openness to- taining-cannabis-or-cannabis October 2, 2016. Accessed September 13, 2020. https://www.denver-
ward the use of marijuana for medical purposes. 19. Boggs DL, Surti T, Gupta A, et al. The effects of cannabidiol (CBD) on cog- post.com/2016/07/19/four-colorado-doctors-suspended-over-medi-
nition and symptoms in outpatients with chronic Schizophrenia a randomized cal-marijuana-recommendations/
With estimates of more than 4 million people using placebo controlled trial. Psychopharmacology. 2018;235(7):1923-1932. 45. In re: Vernon Eugene Proctor, M.D. Mich. Ct. App. Unpublished. March
medical marijuana across the United States, there is 20. Leweke FM, Piomelli D, Pahlisch F, et al. Cannabidiol enhances 14, 2019. Accessed September 13, 2020. https://law.justia.com/cases/
a strong likelihood that medical professionals will anandamide signaling and alleviates psychotic symptoms of schizo- michigan/court-of-appeals-unpublished/2019/342029.html
face questions regarding its efficacy and indications phrenia. Translational Psychiatry. 2012; 2: 94. 46. Lapin T. Doctor loses license after suggesting weed cookies to con-
21. Marconi A, Di Forti M, Lewis CM, et al. Meta-analysis of the associ- trol kid’s tantrums. New York Post. January 28, 2019. Accessed Septem-
for various medical conditions.51 However, research ation between the level of cannabis use and risk of psychosis. Schizophr ber 13, 2020. https://nypost.com/2019/01/28/doctor-loses-license-af-
is sparse, making the risk-to-benefit ratio a challeng- Bull. 2016;42(5): 1262-1269. ter-suggesting-weed-cookies-to-control-kids-tantrums/
ing calculation with many missing variables. 22. Reid S, Bhattacharyya S. Antipsychotic treatment failure in patients 47. Baldwin C. State suspends license for top NJ marijuana doctor. Patch.
As we enter an era of likely increasing research with psychosis and co-morbid cannabis use: A systematic review. Psy- January 10, 2019. Accessed September 13, 2020. https://patch.com/
chiatry Res. 2019; 280:112523. new-jersey/woodbridge/state-suspends-license-top-nj-marijuana-doctor
in medicinal marijuana, it will be important for 23. Sherif M, Radhakrishnan R, D’Souza DC, et al. Human laboratory stud- 48. Cook J. Doctor convicted of health care fraud for selling medical
physicians to stay up to date on the current litera- ies on cannabinoids and psychosis. Biol Psychiatry. 2016;79(7): 526-38. marijuana certificates. Macomb Daily. January 18, 2013. Accessed Sep-
ture so that we can best advise our patients. Aside 24. Roe v TeleTech Customer Care Management (Colorado) LLC, 171 tember 13, 2020. https://www.macombdaily.com/news/doctor-con-
from the clinical aspects of medical marijuana, Wn.2d 736, 257 P.3d 586 (2011) victed-of-health-care-fraud-for-selling-medical-marijuana/article_
25. NV AB 132. 2019. 80th Legislature. Accessed September 13, 2020. 2389d0a5-7efb-5893-983d-6a61caa11032.html
there are also a myriad of social constraints that https://www.leg.state.nv.us/App/NELIS/REL/80th2019/Bill/6191/Overview 49. State v Gear. Ariz. May 6, 2016. Accessed September 13, 2020.
need to be considered. In addition, due to the in- 26. Mass. Gen. Laws Ann. Ch. 94I §§ 1 to 8; 105 Mass. Code Regs. https://caselaw.findlaw.com/az-supreme-court/1734731.html
fancy of medical marijuana, there are several op- 725.650. Accessed September 13, 2020. https://malegislature.gov/ 50. Federation of State Medical Boards. Model guidelines for the recom-
portunities for liability on the part of physicians. Laws/GeneralLaws/PartI/TitleXV/Chapter94i. mendation of marijuana in patient care. April 2016. September 13, 2020.
27. Nev. Rev. Stat. Ann. §§ 453A.800, 453D.100. Accessed September https://www.fsmb.org/siteassets/advocacy/policies/model-guide-
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1. Cannabis, Coca, & Poppy: Nature’s Addictive Plants. DEA Museum. 28. Sharma P, Murthy P, Bharath MM. Chemistry, metabolism, and toxicol- 51. The Marijuana Policy Project. Medical Marijuana Patient Numbers.
Accessed September 12, 2020. https://www.deamuseum.org/ccp/ ogy of cannabis: clinical implications. Iran J Psychiatry 2012;7(4):149-156. May 9, 2020. Accessed September 13, 2020. https://www.mpp.org/is-
cannabis/history.html. 29. Ark. Const. amend. XCVIII, §§ 3, 6. Accessed September 13, 2020. sues/medical-marijuana/state-by-state-medical-marijuana-laws/med-
2. California Proposition 215, the Medical Marijuana Initiative. Ballotpe- https://static.ark.org/eeuploads/arml/Arkansas_Medical_Marijuana_ ical-marijuana-patient-numbers/ ❒
Amendment_of_2016.pdf
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PSY1020_038-042_CME.indd 42 9/30/20 8:26 AM

UMass Memorial Health Care and the University
of Massachusetts Medical School currently have
find YOUR perfect SPOT openings within the Department of Psychiatry.
— wORKING WITH cENTURION — The Department of Psychiatry is a national leader in public sector psychiatry,
child and adolescent psychiatry, neuropsychiatry, biological psychiatry, psycho-
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Centurion is a leading provider of comprehensive our clinical, research, teaching and community partnership activities to help in-
healthcare services to correctional facilities nationwide. dividuals and families transform their lives through recovery from mental illness
We are dedicated to changing lives in the community, and addiction. We are particularly interested in having Faculty join our Department
one patient at a time. who are motivated for a career in clinical research. We are the largest provider of
psychiatric services in central Massachusetts, with over 400 faculty members and
12 hospitals and community mental health centers.
Our residency program trains 7 residents per year, including general psychiatry
and specialty tracks for combined adult and child psychiatry and combined neu-
rology. We offer fellowships in Child and Adolescent Psychiatry, Addiction
Psychiatry, Forensic Psychiatry, Neuropsychiatry, and Adult Developmental Dis-
abilities. Interested candidates should send their curriculum vitae addressed to Dr.
Sheldon Benjamin.
UMass Medical School

Facility Medical Director
(Cape Cod and Islands Mental Health Center, Pocasset, MA)
Provides administrative and clinical oversight for the DMH-operated and
contracted state hospital and community support programs. Clinical Care in our
Partial Hospital program.
Full-Time Inpatient Psychiatrist
(Cape Cod and Islands Mental Health Center, Pocasset, MA)
Psychiatrist, Psychiatric Nurse Practitioner, Work closely with two psychiatric APRNs, a consulting internist, and a
and Psychologist opportunities available in multidisciplinary team.
Full-Time Psychiatrist (Brockton Multi-Service Center, Brockton, MA)
the following states: Outpatient services.
Arizona | California | Delaware | Georgia

For additional information, please contact:
Florida | Kansas | Maryland | Michigan
Marie Hobart, MD, Vice Chair, Public Sector Psychiatry
Minnesota | Nevada | New Hampshire marie.hobart@umassmed.edu
New Mexico | Pennsylvania | Tennessee Interested applicants should apply directly at
https://academicjobsonline.org/ajo/UMASSMED/Psych
(J-1 and H-1B candidates are welcome to apply)
Our dedication to making a diﬀerence and our
passionate team of the best and the brightest UMass Memorial Health Care
healthcare employees have made us one of the
leaders of the correctional healthcare industry. Chief Medical Officer (CHL, Worcester, MA)
Supervision of a large group of professionals and participation in
Whether you are a seasoned professional seeking development efforts serving >22,000 individuals each year.
greater stability or a recent graduate eager to Medical Director (Adult Inpatient Psychiatry, Marlborough, MA)
expand your clinical skills, we have the opportunity Provide psychiatric and medical supervision and
direction to a 22-bed behavioral health unit.
you are seeking.
Adult Inpatient Attending Psychiatrist (PTRC, Worcester, MA)
Inpatient services while providing acute clinical care
General Adult Outpatient Psychiatrist (Worcester, MA)
Outpatient services while providing behavioral healthcare services.
To learn more, contact Holley Schwieterman:
844-472-5874 | Holley@teamcenturion.com Interested applicants should submit a letter
of interest and curriculum vitae addressed to
Sheldon Benjamin, MD:
c/o: Jessica Saintelus, Physician Recruiter
Jessica.Saintelus@umassmemorial.org
http://jobs.jobvite.com/
www.CenturionJobs.com
umassmemorialmedicalgroupphysicians/search?q=&d=Psychiatry
Equal Opportunity Employer
As the leading employer in the Worcester area, we seek talent and
ideas from individuals of varied backgrounds and viewpoints.
PSY1020_043-048_Classifieds.indd 43 9/28/20 1:58 PM

Top Leading Locum Behavioral
Psychiatrist Services wellness recovery prevention
laying the foundation for healthy communities, together
California
Psychiatrist Needed
PSYCHIATRISTS
For clinical staff and leadership positions
California Correctional Facilities $275 - $325 Plus/hr. The State of New Jersey’s Division of Behavioral Health
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• Primary care physicians provide for patient’s physical
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All NYC & Upstate Locations Available packages for full-time positions
Candidates must possess N.J.
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medical license
The Department of Health welcomes
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★
Additionally, the Department participates
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development and incentive programs
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Call: 559.799.8344 department’s tuition reimbursement program
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599.786.5228 / 599.791.0932
H Greystone Park Psychiatric Hospital
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H Trenton Psychiatric Hospital
upon request. Trenton, NJ (Central NJ)
Fax: 888.712.2412
H Ann Klein Forensic Center
Trenton, NJ (Central NJ)
Interested candidates should send a cover letter H Special Treatment Unit
and detailed resume to: Avenel, NJ (Northern NJ)
H Ancora Psychiatric Hospital
Email: imperiallocum@imperiallocum.com MEMBER OF
Evan Feibusch, M.D. | Medical Director, DBHS Hammonton, NJ (Southern NJ)
Evan.Feibusch@doh.nj.gov | 609.913.5316
National Association of
Visit: www.imperiallocum.com Physician Recruiters The State of New Jersey is an Equal Opportunity Employer
RECRUITING FULL TIME & PER DIEM PSYCHIATRISTS

NEW YORK METRO AREAS
Northwell Health’s Behavioral Health Service Line strives to address the diverse mental health needs of the communities we serve by providing a
continuum of accessible, high quality psychiatric and substance abuse services including emergency, crisis, inpatient, and outpatient programs for people
of all ages. Northwell’s clinical programs are complemented by a robust education, training, and research enterprise, including the world-renowned
Psychiatry Research Department at The Zucker Hillside Hospital, which has led cutting-edge investigations that have meaningfully influenced many lives.
TO BOLSTER OUR NETWORK OF OUTSTANDING CARE PROVIDERS,

WE ARE RECRUITING BOARD ELIGIBLE/BOARD CERTIFIED PSYCHIATRISTS FOR THE FOLLOWING POSITIONS:
CHILD INPATIENT PSYCHIATRIST ADOLESCENT INPATIENT EMERGENCY PSYCHIATRIST – Per-Diem
ADOLESCENT UNIT PSYCHIATRIST Cohen Children’s Medical Center, NY
South Oaks Hospital The Zucker Hillside Hospital Long Island Jewish Medical Center, NY
Amityville, NY Glen Oaks, NY
OUTPATIENT PSYCHIATRIST
ADULT INPATIENT PSYCHIATRIST COLLEGE UNIT INPATIENT
Staten Island University Hospital, NY
The Zucker Hillside Hospital PSYCHIATRIST
Glen Oaks, NY The Zucker Hillside Hospital CONSULTATION LIAISON PSYCHIATRIST
Glen Oaks, NY Phelps Memorial Hospital
South Oaks Hospital Sleepy Hollow, NY
PERINATAL PSYCHIATRIST
Amityville, NY The Zucker Hillside Hospital
Staten Island University Hospital
Glen Oaks, NY
Staten Island, NY
Benefits at Northwell Health include:
 Nationally competitive salaries  Academic appointment commensurate with experience

 Comprehensive benefits package  Advanced education opportunities
 Four weeks’ vacation plus paid conference/CME time  College Tuition reimbursement for dependent children
Qualified candidates should forward their CV to Lan Ma: OPR@northwell.edu

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FIND YOUR CAREER BALANCE

IN CALIFORNIA
California Correctional Health In return for your efforts, we offer:
Care Services is seeking proactive, • 40-hour workweek with flexible schedules,
knowledgeable psychiatrists to including 4/10s
join our multidisciplinary teams.
Within the California Department • Generous paid time off and
of Corrections and Rehabilitation’s holiday schedule
facilities, you will find like-minded • 401(k) and 457 plans (tax defer up to
professionals well-versed in the $39,000 - $52,000 per year)
intricate psychiatric and medical • State of California retirement that vests in
PSYCHIATRISTS interplay necessary to treat our
diverse patient population. Here, you
five years (visit www.CalPERS.ca.gov for
retirement formulas)
will see and develop treatment plans
for cases you won’t encounter in any • $10,000 Thank You Bonus to professionals
$266,844 - $320,640 other practice. And with the support newly hired with the State of California
annual salary (Board Certified) of our dedicated medical assistants, • Relocation assistance available to
you’ll be able to devote your time professionals newly hired with the
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with locations throughout California,
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Take the first step in joining one of our teams and contact LaTreese Phillips at
INPATIENT · OUTPATIENT (916) 691-4818 or CentralizedHiringUnit@cdcr.ca.gov. You may also apply
online at www.cchcs.ca.gov.
Effective July 1, 2020, in response to the economic crisis caused by the COVID-19 pandemic, the Personal
Leave Program 2020 (PLP 2020) was implemented. PLP 2020 requires that each full-time employee receive
a 9.23 percent reduction in pay in exchange for 16 hours PLP 2020 leave credits monthly through June 2022.

46 CLASSIFIEDS October 2020
Alaska A career...a lifestyle...an adventure!
As a non-profit, health care organization, Southcentral Foundation serves Alaska Native

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and American Indian people in the Anchorage service area. Our relationship-based Nuka PSYCHIATRIST The doctors of TRADITIONS
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by a separate department, 10 hours of administrative time per week, and no inpatient care. (Above annual salary includes additional seriously and persistently mentally ill and
pay for Board Certification and Acute have openings in the San Francisco Bay
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Contact Jon Kasgnoc | jkasgnoc@southcentralfoundation.com Santa Clara Valley Health and Hospital Angeles, Reno and Seattle. Overall we plan
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minimum of $300,000 per year plus
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health clinics, and custody health inpatient valued at approximately $90,000, to up to
services. Opportunities for additional $500,000, for the industrious physician.
moonlighting also exist within our Our generous benefit package includes over
healthcare system. 6 weeks paid time off per year. If you are
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Experienced Inpatient As the largest public health care system in value diversity and cultural competency, if
Arizona State Hospital Adult Psychiatrist Needed northern California, we offer comprehensive you like innovative programs that are patient
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October 2020
CLASSIFIEDS 47
MINNESOTA NEW HAMPSHIRE
A brand new 14-bed inpatient Geriatric
Psychiatry Unit will be opening in Saint
Psychiatrist Position Joseph Hospital, Nashua, NH (with plans
Adult Psychiatrist to go to 21 beds in the future) PSYCHIATRIST
Excellent Opportunity in California
Albert Lea, Minnesota • Short-term, seeking a local Psychiatrist or AmeriCare Services is pleased to announce
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Diego, 90 miles south of Palm Springs, 60 The Psychiatric Department at Mayo Clinic The compensation is
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miles west of Yuma, Arizona, and just north Health System in Albert Lea & Austin, MN $230.00 to $250.00 per hour.
hospital plans to employ the physician full
of the cosmopolitan city of Mexicali, is seeking BC / BE Psychiatrists to join time with benefits. This position is patient For confidential consideration call
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care and PT admin. duties.
maintains a satellite campus in Calexico, KGallagher@AmCareServices.com
• More work-life balance. • Also seeking Psychiatrists in the area that
and there are several private and public
• Competitive Compensation. wish to earn additional money for one night/
universities located in Mexicali. Imperial
• Pension, Mayo funded defined benefit week of phone call coverage and one
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The position pays a highly competitive • Excellent medical, dental and spending Please contact Terry Good
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week available; Pay Rate: $144 - $163/hour
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crisis management and service delivery of
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www.mentalhealthpartnerships.org

48 CLASSIFIEDS October 2020
Department of Psychiatry
With the continued growth of our Department of Psychiatry and our New General Psychiatry Residency Programs
at Ocean Medical Center and Jersey Shore University Medical Center our vision for Behavioral Health is Bright.
Hackensack Meridian Health is a leading not-for-profit health care network in New Jersey offering a complete range of medical
services, innovative research, and lifeenhancing care aiming to serve as a national model for changing and simplifying health care
delivery through partnerships with innovative companies and focusing on quality and safety.
Through a partnership between Hackensack Meridian Health and Seton Hall University, the School of Medicine will re-define
graduate medical education, research, and clinical practice; reverse the critical physician shortage in both the New York/New Jersey
metropolitan area and the nation; and stimulate economic development in northern New Jersey.
The School of Medicine will be the anchor in the development of a comprehensive health sciences campus that will also include
research facilities and biotechnology endeavors – all in service of educating tomorrow’s doctors, discovering novel therapies, and
facilitating compassionate and effective healthcare that will meet the ever-changing needs of tomorrow’s patients.
The School of Medicine will be the cornerstone of a dynamic venue for the exchange of ideas, the development of healthcare and
research thought leaders and practitioners, and the discovery of novel therapies to meet the medical challenges of the future.
“Ocean Medical Center’s psychiatry program will be a community-based program,’’ said Ramon Solhkhah, M.D., program director for
psychiatry as well as founding Chair of Psychiatry & Behavioral Health at the Hackensack Meridian School of Medicine at Seton Hall
University. “Our new psychiatry residency program will improve clinical care and ultimately encourage future health care leaders
to build practices in the Jersey Shore area,’’
As the area’s premier provider of psychiatric services, Hackensack Meridian Behavioral Health Services has provided comprehensive
mental health and substance abuse services to the residents of Monmouth, Ocean, Middlesex, and Bergen Counties for over forty years.
Due to continued growth and expansion, we are currently accepting applications for Psychiatrists to join our Mental Health and Addic-
tion Interdisciplinary Teams in the following positions:
• Carrier Clinic -Inpatient Attending- Child/Adolescent and Adult/Geriatric–Carrier Clinic (Belle Mead, NJ)
Carrier Clinic – Inpatient- PT House Physician (weekends)
On-Call Weekend Rounding Physician
• Child & Adolescent Section Chief – Includes Pediatric CL: Jersey Shore University Medical Center, (Neptune, NJ)
• Consultation Liaison Psychiatrists: Hackensack University Medical Center (Hackensack, NJ), JFK Medical
Center (Edison, NJ), Ocean Medical Center (Brick, NJ), Jersey Shore University Medical Center (Neptune, NJ)
• Outpatient: Ocean Medical Center (Brick, NJ)
• Staff Psychiatrist for Adult Inpatient Unit: Riverview Medical Center (Red Bank, NJ) and Hackensack Univer-
sity Medical Center (Hackensack, NJ)
• Outpatient Child& Adolescent Psychiatrist: Hackensack University Medical Center (Hackensack, NJ)
• Geriatric Psychiatry: Hackensack University Medical Center (Hackensack, NJ)
• ED/Crisis Unit: Jersey Shore University Medical Center (Neptune, NJ)
Renee.Theobald@hackensackmeridian.org or call: 732 751-3597

Other Adverse Reactions Observed During the Premarketing Evaluation of INGREZZA
for oral use Other adverse reactions of ≥1% incidence and greater than placebo are shown below. The following list does
not include adverse reactions: 1) already listed in previous tables or elsewhere in the labeling, 2) for which a
Brief Summary: for full Prescribing Information and Patient Information, refer drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have
to package insert. clinically significant implications, or 5) which occurred at a rate equal to or less than placebo.
INDICATION AND USAGE Endocrine Disorders: blood glucose increased
INGREZZA® (valbenazine) capsules is indicated for the treatment of adults with tardive dyskinesia. General Disorders: weight increased
CONTRAINDICATIONS Infectious Disorders: respiratory infections
INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of Neurologic Disorders: drooling, dyskinesia, extrapyramidal symptoms (non-akathisia)
INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) Psychiatric Disorders: anxiety, insomnia
have been reported. During controlled trials, there was a dose-related increase in prolactin. Additionally, there was a dose-related
increase in alkaline phosphatase and bilirubin, suggesting a potential risk for cholestasis.
WARNINGS AND PRECAUTIONS
Somnolence Postmarketing Experience
INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such The following adverse reactions have been identified during post-approval use of INGREZZA that are not
as operating a motor vehicle or operating hazardous machinery until they know how they will be affected included in other sections of labeling. Because these reactions are reported voluntarily from a population of
by INGREZZA. uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship
to drug exposure.
QT Prolongation
INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at Immune System Disorders: hypersensitivity reactions (including allergic dermatitis, angioedema, pruritis,
concentrations expected with recommended dosing. In patients taking a strong CYP2D6 or CYP3A4 inhibitor, and urticaria)
or who are CYP2D6 poor metabolizers, INGREZZA concentrations may be higher and QT prolongation clinically Skin and Subcutaneous Tissue Disorders: rash
significant. For patients who are CYP2D6 poor metabolizers or are taking a strong CYP2D6 inhibitor, dose DRUG INTERACTIONS
reduction may be necessary. For patients taking a strong CYP3A4 inhibitor, reduce the dose of INGREZZA Drugs Having Clinically Important Interactions with INGREZZA
to 40 mg once daily. INGREZZA should be avoided in patients with congenital long QT syndrome or with
arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, Table 2: Clinically Significant Drug Interactions with INGREZZA
assess the QT interval before increasing the dosage. Monoamine Oxidase Inhibitors (MAOIs)
Parkinsonism Clinical Implication: Concomitant use of INGREZZA with MAOIs may increase the concentration of
INGREZZA may cause parkinsonism in patients with tardive dyskinesia. Parkinsonism has also been observed monoamine neurotransmitters in synapses, potentially leading to increased
with other VMAT2 inhibitors. In the 3 placebo-controlled clinical studies in patients with tardive dyskinesia, risk of adverse reactions such as serotonin syndrome, or attenuated
the incidence of parkinson-like adverse events was 3% of patients treated with INGREZZA and <1% of treatment effect of INGREZZA.
placebo-treated patients. Postmarketing safety reports have described parkinson-like symptoms, some of which Prevention or Management: Avoid concomitant use of INGREZZA with MAOIs.
were severe and required hospitalization. In most cases, severe parkinsonism occurred within the first 2 weeks
after starting or increasing the dose of INGREZZA. Associated symptoms have included falls, gait disturbances, Examples: isocarboxazid, phenelzine, selegiline
tremor, drooling, and hypokinesia. In cases in which follow-up clinical information was available, parkinson-like Strong CYP3A4 Inhibitors
symptoms were reported to resolve following discontinuation of INGREZZA therapy. Reduce the dose or Clinical Implication: Concomitant use of INGREZZA with strong CYP3A4 inhibitors increased the
discontinue INGREZZA treatment in patients who develop clinically significant parkinson-like signs or symptoms. exposure (Cmax and AUC) to valbenazine and its active metabolite compared
ADVERSE REACTIONS with the use of INGREZZA alone. Increased exposure of valbenazine and its
The following adverse reactions are discussed in more detail in other sections of the labeling: active metabolite may increase the risk of exposure-related adverse reactions.
• Hypersensitivity Prevention or Management: Reduce INGREZZA dose when INGREZZA is coadministered with a strong
• Somnolence CYP3A4 inhibitor.
• QT Prolongation Examples: itraconazole, ketoconazole, clarithromycin
• Parkinsonism Strong CYP2D6 Inhibitors
Clinical Trials Experience Clinical Implication: Concomitant use of INGREZZA with strong CYP2D6 inhibitors increased the
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the exposure (Cmax and AUC) to valbenazine’s active metabolite compared with the
clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not use of INGREZZA alone. Increased exposure of active metabolite may increase
reflect the rates observed in practice. the risk of exposure-related adverse reactions.
Variable and Fixed Dose Placebo-Controlled Trial Experience Prevention or Management: Reduce INGREZZA dose when INGREZZA is coadministered with a strong
CYP2D6 inhibitor.
The safety of INGREZZA was evaluated in 3 placebo-controlled studies, each 6 weeks in duration (fixed dose,
dose escalation, dose reduction), including 445 patients. Patients were 26 to 84 years of age with moderate Examples: paroxetine, fluoxetine, quinidine
to severe tardive dyskinesia and had concurrent diagnoses of mood disorder (27%) or schizophrenia/ Strong CYP3A4 Inducers
schizoaffective disorder (72%). The mean age was 56 years. Patients were 57% Caucasian, 39% African- Clinical Implication: Concomitant use of INGREZZA with a strong CYP3A4 inducer decreased the
American, and 4% other. With respect to ethnicity, 28% were Hispanic or Latino. All subjects continued previous exposure of valbenazine and its active metabolite compared to the use of
stable regimens of antipsychotics; 85% and 27% of subjects, respectively, were taking atypical and typical INGREZZA alone. Reduced exposure of valbenazine and its active metabolite
antipsychotic medications at study entry. may reduce efficacy.
Adverse Reactions Leading to Discontinuation of Treatment Prevention or Management: Concomitant use of strong CYP3A4 inducers with INGREZZA is
A total of 3% of INGREZZA treated patients and 2% of placebo-treated patients discontinued because not recommended.
of adverse reactions.
Examples: rifampin, carbamazepine, phenytoin, St. John’s wort1
Common Adverse Reactions
Digoxin
Adverse reactions that occurred in the 3 placebo-controlled studies at an incidence of ≥2% and greater than
placebo are presented in Table 1. Clinical Implication: Concomitant use of INGREZZA with digoxin increased digoxin levels because
of inhibition of intestinal P-glycoprotein (P-gp).
Table 1: Adverse Reactions in 3 Placebo-Controlled Studies of 6-week Prevention or Digoxin concentrations should be monitored when coadministering
Treatment Duration Reported at ≥2% and >Placebo Management: INGREZZA with digoxin. Increased digoxin exposure may increase the risk
Adverse Reaction1 INGREZZA Placebo of exposure-related adverse reactions. Dosage adjustment of digoxin may
(n=262) (%) (n=183) (%) be necessary.
General Disorders 1
The induction potency of St. John’s wort may vary widely based on preparation.
Somnolence (somnolence, fatigue, sedation) 10.9% 4.2% Drugs Having No Clinically Important Interactions with INGREZZA
Nervous System Disorders Dosage adjustment for INGREZZA is not necessary when used in combination with substrates of CYP1A2,
Anticholinergic effects (dry mouth, constipation, disturbance 5.4% 4.9% CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2E1, or CYP3A4/5 based on in vitro study results.
in attention, vision blurred, urinary retention) OVERDOSAGE
Balance disorders/fall (fall, gait disturbance, dizziness, 4.1% 2.2% Human Experience
balance disorder) The pre-marketing clinical trials involving INGREZZA in approximately 850 subjects do not provide information
Headache 3.4% 2.7% regarding symptoms with overdose.
Akathisia (akathisia, restlessness) 2.7% 0.5% Management of Overdosage
Gastrointestinal Disorders No specific antidotes for INGREZZA are known. In managing overdose, provide supportive care, including close
medical supervision and monitoring, and consider the possibility of multiple drug involvement. If an overdose
Vomiting 2.6% 0.6% occurs, consult a Certified Poison Control Center (1-800-222-1222 or www.poison.org).
Nausea 2.3% 2.1% For further information on INGREZZA, call 84-INGREZZA (844-647-3992).
Musculoskeletal Disorders
Arthralgia 2.3% 0.5% Distributed by: INGREZZA is a registered trademark
Neurocrine Biosciences, Inc. of Neurocrine Biosciences, Inc.
1
Within each adverse reaction category, the observed adverse reactions are listed in order of decreasing frequency. San Diego, CA 92130 CP-VBZ-US-0203v5 05/2020
PSY1020_CV3-CV4_Ingrezza.indd 333 9/28/20 1:40 PM

IN ADULT PATIENTS WITH TARDIVE DYSKINESIA (TD)
Choose INGREZZA
for results you can see1
INGREZZA® (valbenazine) capsules reduced TD severity at 6 weeks,
with results you can start to see as early as 2 weeks¹-³
Not an actual patient
See how INGREZZA reduced TD severity in patients at INGREZZAHCP.com/results
Important Information
INDICATION & USAGE
INGREZZA® (valbenazine) capsules is indicated for the treatment of adults with tardive dyskinesia.
IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS WARNINGS & PRECAUTIONS (continued)
INGREZZA is contraindicated in patients with a history of Parkinsonism
hypersensitivity to valbenazine or any components of INGREZZA. INGREZZA may cause parkinsonism in patients with tardive
Rash, urticaria, and reactions consistent with angioedema dyskinesia. Parkinsonism has also been observed with other
(e.g., swelling of the face, lips, and mouth) have been reported. VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA
treatment in patients who develop clinically significant
WARNINGS & PRECAUTIONS parkinson-like signs or symptoms.
Somnolence
INGREZZA can cause somnolence. Patients should not perform ADVERSE REACTIONS
activities requiring mental alertness such as operating a motor The most common adverse reaction (≥5% and twice the rate
vehicle or operating hazardous machinery until they know how of placebo) is somnolence. Other adverse reactions (≥2% and
they will be affected by INGREZZA. >Placebo) include: anticholinergic effects, balance disorders/falls,
headache, akathisia, vomiting, nausea, and arthralgia.
QT Prolongation
INGREZZA may prolong the QT interval, although the degree of You are encouraged to report negative side effects of prescription
QT prolongation is not clinically significant at concentrations drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or
expected with recommended dosing. INGREZZA should be call 1-800-FDA-1088.
avoided in patients with congenital long QT syndrome or with
Please see the adjacent page for Brief Summary of Prescribing
arrhythmias associated with a prolonged QT interval. For patients
Information and visit www.Neurocrine.com/INGREZZAPI for
at increased risk of a prolonged QT interval, assess the QT
full Prescribing Information.
interval before increasing the dosage.
REFERENCES: 1. INGREZZA [package insert]. San Diego, CA: Neurocrine Biosciences, Inc;
2020. 2. Hauser RA, Factor SA, Marder SR, et al. KINECT 3: a phase 3 randomized, double-
blind, placebo-controlled trial of valbenazine for tardive dyskinesia. Am J Psychiatry.
©2020 Neurocrine Biosciences, Inc. All Rights Reserved. CP-VBZ-US-1040v2 02/2020 2017;174(5):476-484. 3. Data on file. Neurocrine Biosciences, Inc.
PSY1020_CV3-CV4_Ingrezza.indd 444 9/28/20 1:40 PM

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EARN 1.

Peer-Reviewed • Practice-Oriented October 2020 • Vol. XXXVII, No. 10

Is the Country Experiencing

• SPRAVATO® is not approved as an anesthetic

MDD=major depressive disorder. Important Safety Information

PSY1020_CV2-006_Spravato.indd 222 9/30/20 9:18 AM

PSY1020_CV2-006_Spravato.indd 1 9/30/20 9:18 AM

PSY1020_CV2-006_Spravato.indd 2 9/30/20 9:18 AM

PSY1020_CV2-006_Spravato.indd 3 9/30/20 9:18 AM

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Sedation Sense of Smell

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Females and Males of Reproductive Potential

© 2019 Janssen Pharmaceutical Companies

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EDITORIAL BOARD SECTION EDITORS FROM THE CHAIRMAN

Carl P. Malmquist, MD, MS

PSY1020_007_ChairmanLetter.indd 7 9/30/20 10:11 AM

have a new look!

Updated features include:

PSY1020_008_HouseAd.indd 8 9/30/20 11:06 AM

of Medicine From a Disaster Trauma Lens

John J. Miller, MD | Editor in Chief 10.2020 VOLUME 37 NUMBER 10 NEUROPSYCHIATRY

Amherst that something shifted in- I would need to become a competent

PSY1020_009_013_Editorial-TOC.indd 9 9/30/20 11:15 AM

THIS ISN’T JUST A COFFEE RUN.

Important Safety Information

PSY1020_010-012_Caplyta.indd 10 9/28/20 1:39 PM

PSY1020_010-012_Caplyta.indd 11 9/28/20 1:39 PM

PSY1020_010-012_Caplyta.indd 12 9/28/20 1:39 PM

FROM THE PAGES OF

The Ethics of Reopening

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Special Report Chairperson

FORENSIC PSYCHIATRY PART 2

Mentally incompetent to stand trial; a person is mentally

PSY1020_014-017_SReport.indd 14 9/30/20 8:59 AM

PSY1020_014-017_SReport.indd 15 9/30/20 8:59 AM

KEY POINTS Psychopathy: Insights

overwhelmed and needs reform.

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Understanding Adult Fire Setting, Pyromania, and Arson

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Presidential Election Anxiety

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ly affected our economy, although it

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Treatment they can wear

The first and only FDA-approved transdermal

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Contraindications: Severe hepatic impairment (Child-Pugh C) or a history of hypersensitivity reactions to asenapine

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Mental Health Pandemic

During late June, 40% of US adults reported

For your adult

Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, angioedema, hypotension, tachycardia,

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IMPORTANT SAFETY INFORMATION, Continued SEC

Treatment they can wear