Raktažodžiai: elektros impulsų terapija, šizofrenijos spektro sutrikimai, nuotaikos sutrikimai, P... more Raktažodžiai: elektros impulsų terapija, šizofrenijos spektro sutrikimai, nuotaikos sutrikimai, P300, kognityviosios funkcijos. Santrauka Klausos sukeltasis potencialas P300 yra neurofiziologinis tyrimo metodas, skirtas objektyviam kai kurių žmogaus kognityviųjų funkcijų įvertinimui. Elektros impulsų terapija (EIT) yra efektyvus kai kurių psichikos sutrikimų, nepasiduodančių įprastai medikamentinei terapijai, gydymo metodų. Jos metu, leidžiant impulsinę elektros srovę per smegenis, iššaukiamas generalizuotas bioelektrinio aktyvumo iškrūvis. Jo poveikyje smegenyse ir neuronuose atsiranda įvairių fiziologinių pokyčių, kurie duoda teigiamą terapinį efektą. Tai saugi procedūra, ypač taikant modifikuotą EIT metodą -kai pacientas trumpam užmigdomas, jam suleidžiami miorelaksantai ir taip išvengiama klinikinio traukulių priepuolio. EIT poveikio mechanizmai dar nėra gerai ištirti, tačiau kartais stebimi neigiami šalutiniai reiškiniai, apimantys daugiausia atminties procesus. EIT įtaka kognityviosioms paciento funkcijoms ištirta mažai, todėl darbo tikslas buvo įvertinti EIT poveikį klausos sukeltajam potencialui P300. Ištirti 38 žmonės -21 moteris ir 17 vyrų. Amžiaus vidurkis -44,5±13,5 metų. Pacientai buvo suskirstyti į dvi grupes pagal diagnozę: pirmą grupę sudarė šizofrenijos spektro sutrikimų turintys pacientai, o antrą -pacientai su nuotaikos sutrikimais. Abiem pacientų grupėms buvo parinktos kontrolinės sveikų žmonių grupės. Sukeltasis potencialas P300 buvo registruojamas Fz, Cz, Pz elektrodais diena prieš pirmą EIT procedūrą ir pabaigus visą EIT kursą. Pacientų gauna-ĮVADAS Klausos sukeltasis potencialas P300 yra vienas iš su įvykiu susijusių potencialų (SĮSP, angl. event-related potentials -ERPs) -neurofiziologinių tyrimo metodų,
ERPs could be helpful in the objectification of many psychological measures. In the last few deca... more ERPs could be helpful in the objectification of many psychological measures. In the last few decades one of the most commonly used ERPs has been the mismatch negativity (MMN) potential. It may be used to detect cognitive dysfunction in patients suffering from schizophrenia, dementia, depression, and can also be successfully applied in treatment monitoring. Nevertheless, changes of MMN parameters (prolongation of latency or reduction of amplitude) are not sufficiently specific to help to diagnose particular diseases. In this study we looked for more strict and specific MMN characteristics selective for schizophrenia. Fifteen healthy human subjects and twelve suffering from schizophrenia spectrum disorders were studied. Two new parameters were considered: the speed of ascending part of MMN slope (SAS) and the half area of the MMN wave. These two measures could differentiate the early stages of cognitive processing disturbances in schizophrenia spectrum disorders. S h o r t c o m m u n i c a t i o n NEU OBIOLOGI E EXPE IMENT LIS
Repetitive transcranial magnetic stimulation (rTMS) is a rapidly expanding mean in drug resistant... more Repetitive transcranial magnetic stimulation (rTMS) is a rapidly expanding mean in drug resistant depression treatment. Yet, despite vast research in this field, exact neurophysiological mechanism of rTMS therapy still remains unclear. This results in difficulties choosing suitable rTMS parameters in advance and compromises thorough evaluation of efficacy after the treatment. In order to obtain more explicit assessment of rTMS therapy in the psychiatric field, we evaluated and compared the influence of two most widely used antidepressive rTMS protocols on EEG band power spectrum and relation to clinical test scores (MADRS, BDI, HAM-D17). Forty-five patients (12 male, 33 female, mean age 52.16 years) participated in the study. Twenty-three patients received high frequency (10 Hz) stimulation, the rest 22 were stimulated using low frequency (1 Hz) protocol. Both groups received 10 to 15 daily rTMS sessions. EEG recordings and clinical tests were obtained the day before rTMS course and...
Summary ANALYSIS OF DEPENDENCE OF N400 RESPONSE ON AGE Back ground. N400 potential is a language-... more Summary ANALYSIS OF DEPENDENCE OF N400 RESPONSE ON AGE Back ground. N400 potential is a language-related neurophysiological brain research method. It is necessary to evaluate factors, influencing this potential in order to correctly interpret the results of analysis. One of these factors is the age of participants. Aim of the study. The main aim of the research was to test whether there is statistically significant changes in latency and amplitude of N400 response related to age. Materials and methods. Event-related potentials were recorded from 8 younger (M=23 years, SD=1.5) and 8 older (M=48 years, SD=7.8) adults as they performed a semantic mismatch task. Participants read 50 sentences appearing by one word displayed for 1 s at a time (e. g. “Yesterday it rained all day” or “Yesterday it rained all week”) followed by 5 s black screen during which decision whether the end of the sentence was appropriate to context was reported. Two N400 parameters – mean amplitude and peak latency...
Auditory steady-state responses (ASSRs) are widely applied to test brain ability to follow extern... more Auditory steady-state responses (ASSRs) are widely applied to test brain ability to follow external stimulation and this appeared to be a promising method in neuropsychiatric disorders. Nevertheless, there is no established conclusion on the way aging affects phase-locking measures of ASSRs in healthy subjects. We aimed to identify the effects of aging on phaselocking measures of 40 Hz ASSR. The effect of aging was tested in a sample of 46 healthy male subjects (20-58 years old) during eyes open condition. Stimuli were 500 ms trains, consisting of 20 identical clicks (1.5 ms burst of white noise) delivered binaurally. Time-frequency analysis of the data was performed and phase-locking index, evoked amplitude and total intensity measures were extracted and decomposed by non-negative multi-way factorization. As shown by curve-fitting analyses, phase-locking index and evoked amplitudes were diminishing with age in the linear manner. This was also proven by ANOVA testing when sample was...
We aimed to evaluate the effect of changing attentional demands towards stimulation in healthy su... more We aimed to evaluate the effect of changing attentional demands towards stimulation in healthy subjects on P50 potential-related high-frequency beta and gamma oscillatory responses, P50 and N100 peak amplitudes and their gating measures. There are no data showing effect of attention on P50 potential-related beta and gamma oscillatory responses and previous results of attention effects on P50 and N100 amplitudes and gating measures are inconclusive. Nevertheless the variation in the level of attention may be a source of variance in the recordings as well as it may provide additional information about the pathology under study. Nine healthy volunteers participated in the study. A standard paired stimuli auditory P50 potential paradigm was applied. Four stimulation conditions were selected: focused attention (stimuli pair counting), unfocused attention (sitting with open eyes), easy distraction (reading a magazine article), and difficult distraction (searching for Landolt rings with ap...
This 52-week open-label extension (OLE) to a double-blind placebo-controlled recurrence preventio... more This 52-week open-label extension (OLE) to a double-blind placebo-controlled recurrence prevention study examined the long-term safety and efficacy of flexibly-dosed paliperidone extended-release (ER) tablets in patients with schizophrenia. Patients entering the OLE either entered from the double-blind phase (placebo or paliperidone ER treatment) or entered directly from the run-in or stabilization phase (paliperidone ER) of the earlier study. During the OLE, patients were treated with flexibly-dosed paliperidone ER (3-15 mg/day; 9 mg starting dose). Safety and tolerability assessments included incidence of adverse events and extrapyramidal symptoms. Efficacy was also assessed. The study population (n=235) was predominantly men (66%), 18-58 years of age. Twelve patients (5%) experienced an adverse event requiring treatment discontinuation. One or more serious treatment-emergent adverse events were reported in 13 patients (6%). There was one death. The mean Positive and Negative Synd...
ABSTRACT Aim of the work: to reveal the association between the objective quality of life and its... more ABSTRACT Aim of the work: to reveal the association between the objective quality of life and its subjective estimation by patients with mental disorders according to some indicators of quality of life specific to mental disorder. The first part of the work reviews the main disorders and their psychological and social consequences, the definition and indicators of quality of life and its objective estimation, the influence of social, psychological factors and patient’s condition on the subjective estimation of quality of life. The second part contains questionnaire data collected from 100 adult patients during their stay at the hospital. The respondents estimated their own health mostly as good, although the majority of them were long term patients with frequent readmissions, jobless due to their condition, and living on disablement allowances and social support. Some had irregular jobs or were engaged in some craft. Most of them resided with their relatives and estimated their living conditions as partially or rather satisfactory. The respondents’ social communication was limited to their nearest relatives and everyday needs. A few were regularly involved in community activities. Most patients were satisfied with their social communication, however participation in community activities did not respond to their expectations. Most people with mental disorders believed they could go on their own in everyday life, however they had difficulties in contacting other people and keeping relations with them. The respondents also believed that due to mental illness their life changed and its quality became poorer. They attributed themselves to unlucky people, nevertheless they considered their life in the whole satisfactory or good. They would like to modify their life, but just a few were convinced to be able to manage on their own. They would like to be supported by their relatives and workers of various institutions.
Progress in Neuro-Psychopharmacology and Biological Psychiatry, 2005
We investigated effects of olanzapine (5-10 mg/day) on passive and active attention in 11 patient... more We investigated effects of olanzapine (5-10 mg/day) on passive and active attention in 11 patients with schizophrenia spectrum disorders and 15 healthy controls by using auditory evoked potentials (AEPs) mismatch negativity (MMN) and P300. AEPs were elicited during active and passive auditory boddballQ paradigms before, after 2 weeks and 4 weeks of olanzapine treatment. Baseline P300 amplitudes, but not MMN, were significantly reduced in patients compared with controls. Although clinical signs improved significantly measured by Positive and Negative Syndrome Scale (PANSS), olanzapine had no significant effects on latencies and amplitudes of MMN and P300. Thus, olanzapine does not have effects on active and passive attention in patients with schizophrenia spectrum disorders. Four weeks olanzapine treatment may be insufficient for the improvement of cognitive dysfunction in terms of inability to focus on relevant stimuli in these patients. D
Results: Controls showed a lesser fronto-central pre-stimulus theta power (− 2.512, p = 0.012), w... more Results: Controls showed a lesser fronto-central pre-stimulus theta power (− 2.512, p = 0.012), which was negatively correlated with parietal beta ITC following target response (− 0.679, p = 0.001). This relationship was absent in patients (− 0.165, p = 0.462) and correlation difference (p b 0.05). There was, however, no group difference in beta ITC (− 0.439, p = 0.639). Conclusions: We present this relationship as a correlate of sensorymotor transformation, disrupted in schizophrenia without a manifest effect on beta ITC. Excess task-irrelevant activity (perhaps secondary to dopaminergic neuron-modulation of GABA and NMDA networks) could be causative.
40 Hz auditory steady-state responses (ASSRs) were recorded in 14 schizophrenic medicated patient... more 40 Hz auditory steady-state responses (ASSRs) were recorded in 14 schizophrenic medicated patients in eyes-open and eyes-closed conditions as previously done in healthy volunteers. Patients show significantly increased precision of the evoked response with eyes closed (P ¼ 0.04), and an increase of broadband noise activity when eyes are open (P ¼ 0.05).
We evaluated the efficacy of paliperidone extended-release (ER), an investigational psychotropic ... more We evaluated the efficacy of paliperidone extended-release (ER), an investigational psychotropic agent, in delaying symptom recurrence in adult patients with schizophrenia and its safety and tolerability. In this randomized, double-blind, placebo-controlled, multicenter study, patients' symptoms were stabilized during an 8-week run-in and a 6-week stabilization phases using open-label, flexibly dosed paliperidone ER (3-15 mg once daily, starting dose = 9 mg). The primary efficacy variable was the time of first recurrence of schizophrenia symptoms, which included predefined changes in symptom scores, psychiatric hospitalization, self-injury, and suicidal or aggressive behavior during the double-blind phase (paliperidone ER or placebo treatment). Based on positive efficacy, the study was terminated at the preplanned interim analysis (43 recurrence events). The interim analysis (primary analysis) included 113 patients (mean age = 41 years; 51% men, 85% white). In the intent-to-treat group, 14 paliperidone ER-treated patients (25%) experienced a recurrence event versus 29 (53%) for placebo. Time-to-recurrence was significantly different, favoring the paliperidone ER group (P = 0.005, log-rank test): 25% quantile of time-to-recurrence was 83 days (paliperidone ER) versus 23 days (placebo). Final analyses (n = 205) were confirmatory. During initial open-label treatment with paliperidone ER, symptoms improved significantly. This improvement was maintained with continued treatment, as were functioning and quality-of-life measures. Treatment-emergent adverse events rates were similar: 35% for paliperidone ER and 40% for placebo. Paliperidone ER treatment versus placebo significantly delayed time-to-recurrence in patients with schizophrenia, maintained symptom stability and measures of functioning, and was generally well tolerated in this patient population.
Raktažodžiai: elektros impulsų terapija, šizofrenijos spektro sutrikimai, nuotaikos sutrikimai, P... more Raktažodžiai: elektros impulsų terapija, šizofrenijos spektro sutrikimai, nuotaikos sutrikimai, P300, kognityviosios funkcijos. Santrauka Klausos sukeltasis potencialas P300 yra neurofiziologinis tyrimo metodas, skirtas objektyviam kai kurių žmogaus kognityviųjų funkcijų įvertinimui. Elektros impulsų terapija (EIT) yra efektyvus kai kurių psichikos sutrikimų, nepasiduodančių įprastai medikamentinei terapijai, gydymo metodų. Jos metu, leidžiant impulsinę elektros srovę per smegenis, iššaukiamas generalizuotas bioelektrinio aktyvumo iškrūvis. Jo poveikyje smegenyse ir neuronuose atsiranda įvairių fiziologinių pokyčių, kurie duoda teigiamą terapinį efektą. Tai saugi procedūra, ypač taikant modifikuotą EIT metodą -kai pacientas trumpam užmigdomas, jam suleidžiami miorelaksantai ir taip išvengiama klinikinio traukulių priepuolio. EIT poveikio mechanizmai dar nėra gerai ištirti, tačiau kartais stebimi neigiami šalutiniai reiškiniai, apimantys daugiausia atminties procesus. EIT įtaka kognityviosioms paciento funkcijoms ištirta mažai, todėl darbo tikslas buvo įvertinti EIT poveikį klausos sukeltajam potencialui P300. Ištirti 38 žmonės -21 moteris ir 17 vyrų. Amžiaus vidurkis -44,5±13,5 metų. Pacientai buvo suskirstyti į dvi grupes pagal diagnozę: pirmą grupę sudarė šizofrenijos spektro sutrikimų turintys pacientai, o antrą -pacientai su nuotaikos sutrikimais. Abiem pacientų grupėms buvo parinktos kontrolinės sveikų žmonių grupės. Sukeltasis potencialas P300 buvo registruojamas Fz, Cz, Pz elektrodais diena prieš pirmą EIT procedūrą ir pabaigus visą EIT kursą. Pacientų gauna-ĮVADAS Klausos sukeltasis potencialas P300 yra vienas iš su įvykiu susijusių potencialų (SĮSP, angl. event-related potentials -ERPs) -neurofiziologinių tyrimo metodų,
ERPs could be helpful in the objectification of many psychological measures. In the last few deca... more ERPs could be helpful in the objectification of many psychological measures. In the last few decades one of the most commonly used ERPs has been the mismatch negativity (MMN) potential. It may be used to detect cognitive dysfunction in patients suffering from schizophrenia, dementia, depression, and can also be successfully applied in treatment monitoring. Nevertheless, changes of MMN parameters (prolongation of latency or reduction of amplitude) are not sufficiently specific to help to diagnose particular diseases. In this study we looked for more strict and specific MMN characteristics selective for schizophrenia. Fifteen healthy human subjects and twelve suffering from schizophrenia spectrum disorders were studied. Two new parameters were considered: the speed of ascending part of MMN slope (SAS) and the half area of the MMN wave. These two measures could differentiate the early stages of cognitive processing disturbances in schizophrenia spectrum disorders. S h o r t c o m m u n i c a t i o n NEU OBIOLOGI E EXPE IMENT LIS
Repetitive transcranial magnetic stimulation (rTMS) is a rapidly expanding mean in drug resistant... more Repetitive transcranial magnetic stimulation (rTMS) is a rapidly expanding mean in drug resistant depression treatment. Yet, despite vast research in this field, exact neurophysiological mechanism of rTMS therapy still remains unclear. This results in difficulties choosing suitable rTMS parameters in advance and compromises thorough evaluation of efficacy after the treatment. In order to obtain more explicit assessment of rTMS therapy in the psychiatric field, we evaluated and compared the influence of two most widely used antidepressive rTMS protocols on EEG band power spectrum and relation to clinical test scores (MADRS, BDI, HAM-D17). Forty-five patients (12 male, 33 female, mean age 52.16 years) participated in the study. Twenty-three patients received high frequency (10 Hz) stimulation, the rest 22 were stimulated using low frequency (1 Hz) protocol. Both groups received 10 to 15 daily rTMS sessions. EEG recordings and clinical tests were obtained the day before rTMS course and...
Summary ANALYSIS OF DEPENDENCE OF N400 RESPONSE ON AGE Back ground. N400 potential is a language-... more Summary ANALYSIS OF DEPENDENCE OF N400 RESPONSE ON AGE Back ground. N400 potential is a language-related neurophysiological brain research method. It is necessary to evaluate factors, influencing this potential in order to correctly interpret the results of analysis. One of these factors is the age of participants. Aim of the study. The main aim of the research was to test whether there is statistically significant changes in latency and amplitude of N400 response related to age. Materials and methods. Event-related potentials were recorded from 8 younger (M=23 years, SD=1.5) and 8 older (M=48 years, SD=7.8) adults as they performed a semantic mismatch task. Participants read 50 sentences appearing by one word displayed for 1 s at a time (e. g. “Yesterday it rained all day” or “Yesterday it rained all week”) followed by 5 s black screen during which decision whether the end of the sentence was appropriate to context was reported. Two N400 parameters – mean amplitude and peak latency...
Auditory steady-state responses (ASSRs) are widely applied to test brain ability to follow extern... more Auditory steady-state responses (ASSRs) are widely applied to test brain ability to follow external stimulation and this appeared to be a promising method in neuropsychiatric disorders. Nevertheless, there is no established conclusion on the way aging affects phase-locking measures of ASSRs in healthy subjects. We aimed to identify the effects of aging on phaselocking measures of 40 Hz ASSR. The effect of aging was tested in a sample of 46 healthy male subjects (20-58 years old) during eyes open condition. Stimuli were 500 ms trains, consisting of 20 identical clicks (1.5 ms burst of white noise) delivered binaurally. Time-frequency analysis of the data was performed and phase-locking index, evoked amplitude and total intensity measures were extracted and decomposed by non-negative multi-way factorization. As shown by curve-fitting analyses, phase-locking index and evoked amplitudes were diminishing with age in the linear manner. This was also proven by ANOVA testing when sample was...
We aimed to evaluate the effect of changing attentional demands towards stimulation in healthy su... more We aimed to evaluate the effect of changing attentional demands towards stimulation in healthy subjects on P50 potential-related high-frequency beta and gamma oscillatory responses, P50 and N100 peak amplitudes and their gating measures. There are no data showing effect of attention on P50 potential-related beta and gamma oscillatory responses and previous results of attention effects on P50 and N100 amplitudes and gating measures are inconclusive. Nevertheless the variation in the level of attention may be a source of variance in the recordings as well as it may provide additional information about the pathology under study. Nine healthy volunteers participated in the study. A standard paired stimuli auditory P50 potential paradigm was applied. Four stimulation conditions were selected: focused attention (stimuli pair counting), unfocused attention (sitting with open eyes), easy distraction (reading a magazine article), and difficult distraction (searching for Landolt rings with ap...
This 52-week open-label extension (OLE) to a double-blind placebo-controlled recurrence preventio... more This 52-week open-label extension (OLE) to a double-blind placebo-controlled recurrence prevention study examined the long-term safety and efficacy of flexibly-dosed paliperidone extended-release (ER) tablets in patients with schizophrenia. Patients entering the OLE either entered from the double-blind phase (placebo or paliperidone ER treatment) or entered directly from the run-in or stabilization phase (paliperidone ER) of the earlier study. During the OLE, patients were treated with flexibly-dosed paliperidone ER (3-15 mg/day; 9 mg starting dose). Safety and tolerability assessments included incidence of adverse events and extrapyramidal symptoms. Efficacy was also assessed. The study population (n=235) was predominantly men (66%), 18-58 years of age. Twelve patients (5%) experienced an adverse event requiring treatment discontinuation. One or more serious treatment-emergent adverse events were reported in 13 patients (6%). There was one death. The mean Positive and Negative Synd...
ABSTRACT Aim of the work: to reveal the association between the objective quality of life and its... more ABSTRACT Aim of the work: to reveal the association between the objective quality of life and its subjective estimation by patients with mental disorders according to some indicators of quality of life specific to mental disorder. The first part of the work reviews the main disorders and their psychological and social consequences, the definition and indicators of quality of life and its objective estimation, the influence of social, psychological factors and patient’s condition on the subjective estimation of quality of life. The second part contains questionnaire data collected from 100 adult patients during their stay at the hospital. The respondents estimated their own health mostly as good, although the majority of them were long term patients with frequent readmissions, jobless due to their condition, and living on disablement allowances and social support. Some had irregular jobs or were engaged in some craft. Most of them resided with their relatives and estimated their living conditions as partially or rather satisfactory. The respondents’ social communication was limited to their nearest relatives and everyday needs. A few were regularly involved in community activities. Most patients were satisfied with their social communication, however participation in community activities did not respond to their expectations. Most people with mental disorders believed they could go on their own in everyday life, however they had difficulties in contacting other people and keeping relations with them. The respondents also believed that due to mental illness their life changed and its quality became poorer. They attributed themselves to unlucky people, nevertheless they considered their life in the whole satisfactory or good. They would like to modify their life, but just a few were convinced to be able to manage on their own. They would like to be supported by their relatives and workers of various institutions.
Progress in Neuro-Psychopharmacology and Biological Psychiatry, 2005
We investigated effects of olanzapine (5-10 mg/day) on passive and active attention in 11 patient... more We investigated effects of olanzapine (5-10 mg/day) on passive and active attention in 11 patients with schizophrenia spectrum disorders and 15 healthy controls by using auditory evoked potentials (AEPs) mismatch negativity (MMN) and P300. AEPs were elicited during active and passive auditory boddballQ paradigms before, after 2 weeks and 4 weeks of olanzapine treatment. Baseline P300 amplitudes, but not MMN, were significantly reduced in patients compared with controls. Although clinical signs improved significantly measured by Positive and Negative Syndrome Scale (PANSS), olanzapine had no significant effects on latencies and amplitudes of MMN and P300. Thus, olanzapine does not have effects on active and passive attention in patients with schizophrenia spectrum disorders. Four weeks olanzapine treatment may be insufficient for the improvement of cognitive dysfunction in terms of inability to focus on relevant stimuli in these patients. D
Results: Controls showed a lesser fronto-central pre-stimulus theta power (− 2.512, p = 0.012), w... more Results: Controls showed a lesser fronto-central pre-stimulus theta power (− 2.512, p = 0.012), which was negatively correlated with parietal beta ITC following target response (− 0.679, p = 0.001). This relationship was absent in patients (− 0.165, p = 0.462) and correlation difference (p b 0.05). There was, however, no group difference in beta ITC (− 0.439, p = 0.639). Conclusions: We present this relationship as a correlate of sensorymotor transformation, disrupted in schizophrenia without a manifest effect on beta ITC. Excess task-irrelevant activity (perhaps secondary to dopaminergic neuron-modulation of GABA and NMDA networks) could be causative.
40 Hz auditory steady-state responses (ASSRs) were recorded in 14 schizophrenic medicated patient... more 40 Hz auditory steady-state responses (ASSRs) were recorded in 14 schizophrenic medicated patients in eyes-open and eyes-closed conditions as previously done in healthy volunteers. Patients show significantly increased precision of the evoked response with eyes closed (P ¼ 0.04), and an increase of broadband noise activity when eyes are open (P ¼ 0.05).
We evaluated the efficacy of paliperidone extended-release (ER), an investigational psychotropic ... more We evaluated the efficacy of paliperidone extended-release (ER), an investigational psychotropic agent, in delaying symptom recurrence in adult patients with schizophrenia and its safety and tolerability. In this randomized, double-blind, placebo-controlled, multicenter study, patients' symptoms were stabilized during an 8-week run-in and a 6-week stabilization phases using open-label, flexibly dosed paliperidone ER (3-15 mg once daily, starting dose = 9 mg). The primary efficacy variable was the time of first recurrence of schizophrenia symptoms, which included predefined changes in symptom scores, psychiatric hospitalization, self-injury, and suicidal or aggressive behavior during the double-blind phase (paliperidone ER or placebo treatment). Based on positive efficacy, the study was terminated at the preplanned interim analysis (43 recurrence events). The interim analysis (primary analysis) included 113 patients (mean age = 41 years; 51% men, 85% white). In the intent-to-treat group, 14 paliperidone ER-treated patients (25%) experienced a recurrence event versus 29 (53%) for placebo. Time-to-recurrence was significantly different, favoring the paliperidone ER group (P = 0.005, log-rank test): 25% quantile of time-to-recurrence was 83 days (paliperidone ER) versus 23 days (placebo). Final analyses (n = 205) were confirmatory. During initial open-label treatment with paliperidone ER, symptoms improved significantly. This improvement was maintained with continued treatment, as were functioning and quality-of-life measures. Treatment-emergent adverse events rates were similar: 35% for paliperidone ER and 40% for placebo. Paliperidone ER treatment versus placebo significantly delayed time-to-recurrence in patients with schizophrenia, maintained symptom stability and measures of functioning, and was generally well tolerated in this patient population.
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Papers by Valentinas Mačiulis