Different safety profiles of risperidone and paliperidone extended-release: a double-blind, placebo-controlled trial with healthy volunteers
ABSTRACT The present study investigated subjective experiences related to secondary negative symptoms and cognitive performance in healthy volunteers in response to the repeated administration of paliperidone extended-release (ER) and risperidone in a double-blind, placebo-controlled trial.
Participants (n = 32) received a fixed dose of one of three study medications for three consecutive days: 6 mg of paliperidone ER, 3 mg of risperidone, or placebo. Subjects were evaluated at baseline and after the first and third administrations of the medications by using the Neuroleptic-Induced Deficit Syndrome Scale and the Scale for the Assessment of Negative Symptoms. Cognitive function was measured at baseline and after the third administration of the medications by using the computerized neuropsychological test.
Risperidone was associated with more detrimental subjective experiences compared with paliperidone ER and placebo (p < .05), and these differences persisted after controlling for mental and physical sedation. Analysis of computerized neuropsychological test variables revealed significant differences in the changes in Stroop word-color test results from baseline between the paliperidone ER and risperidone groups (p < .005) and between the placebo and risperidone groups (p < .005).
These results suggest that paliperidone ER may have a better safety profile than risperidone in terms of negative subjective experiences and cognitive function among normal volunteers.
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ABSTRACT: OBJECTIVE: This study assessed whether the subjective experience of patients with schizophrenia improved after switching from an oral antipsychotic to flexibly-dosed paliperidone extended-release. METHODS: We conducted a 24-week, multicenter, non-comparative, open-label trial. A total of 387 patients with schizophrenia participated the study. The primary study outcome was the change in subjective symptoms measured by the Symptom Checklist-90-Revised version (SCL-90-R) from baseline. Visual analogue scales were used for sleep and daytime somnolence as secondary subjective assessments. The clinical global impression-schizophrenia-severity scale was used to assess overall symptom severity. Social functioning was evaluated by the personal and social performance scale. Adverse events were also evaluated. RESULTS: All subjective symptoms measured by the SCL-90-R improved significantly. The early responders, who achieved >20% reduction in the SCL-90-R within 1 week, maintained significantly lower severity through the 24 weeks. The clinical global impression-schizophrenia-severity scale and personal and social performance scores also improved significantly. The visual analogue scales revealed that daytime somnolence improved significantly, whereas nocturnal sleep quality was unaltered. CONCLUSION: Our results suggest that switching to paliperidone extended-release was associated with improvements in various subjective symptoms, decreased overall symptom severity, and increased social functioning. The results also suggest that early detection and reduction of subjective symptoms are important for treatment outcome. Copyright © 2013 John Wiley & Sons, Ltd.Human Psychopharmacology Clinical and Experimental 03/2013; 28(2). DOI:10.1002/hup.2284 · 1.85 Impact Factor
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ABSTRACT: Abstract Objective. This study was to evaluate the effects on clinical symptoms and cognitive function of switching the treatment of elderly patients with schizophrenia from risperidone to paliperidone (PAL). Methods. This study was a 12-weeks, preliminary open-label trial. The subjects were 17 inpatients. Their extrapyramidal symptoms (EPS) were assessed using the Drug-Induced Extrapyramidal Symtoms Scale (DIEPSS), Abnormal Involuntary Movement Scale (AIMS), and Barnes Akathisia Scale (BAS), and their cognitive function was assessed using the Brief Assessment Cognition in Schizophrenia: Japanese language version (BACS-J), and their clinical symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity of illness scale (CGI-S) at the 0 and 12 weeks. Results. The DIEPSS and BAS significantly improved after switching from risperidone to PAL. Furthermore, improvement was found on AIMS. The mean change from baseline in z-score of the digit sequencing task was significantly increased. All items on the PANSS and CGI-S were not significant; however, changes in some cognitive function were correlated with changes in EPS. Conclusions. The results of this study suggest the possibility that switching elderly patients from risperidone to PAL may have improved pre-existing EPS, and may also have helped improve working memory.International Journal of Psychiatry in Clinical Practice 09/2013; 18(1). DOI:10.3109/13651501.2013.845218 · 1.31 Impact Factor