BackgroundPrevious studies with extended-release (ER) paliperidone have reported an effective outcome in terms of personal and social functioning improvement and also reported schizophrenia symptom improvement. The main objectives of this study were to further investigate improvements in symptom control and social functioning of paliperidone ER and acknowledge the safety profile of paliperidone ER in Thai patients with schizophrenia.Patients and methodsPatients with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders criteria were allowed flexible 3–12 mg/day dosing during the 10-week study duration. Patients were interviewed and assessed in social functioning using the Personal and Social Performance (PSP) scale. Patients were also rated on overall severity of illness using the Clinical and Global Impressions – Severity (CGI-S) scale.ResultsIn total, 40 patients were enrolled, 80% of enrolled patients (n = 32) completed the 10-week study period. Thirty-eight eligible patients were included in the intention-to-treat analysis set (male 39.5%, female 60.5%). One patient was lost to follow-up without postbaseline-efficacy measurements. Another patient was terminated early due to a change in diagnosis during the trial. Statistically significant improvements from baseline in PSP total score were observed at all time points. Clinically relevant improvement in PSP (increase of at least one 10-point category) was observed in 47.40% of patients at end point. Improvement in CGI-S was observed at end point (P < 0.001). The mean reduction ± standard deviation at end point in CGI-S was 0.8 ± 1.04 (95% confidence interval 0.48–1.16). The most commonly reported adverse events (≥5% of patients) were daytime drowsiness (15%) and headache (15%). Three subjects (7.5%) discontinued due to adverse events.ConclusionThis study suggests that paliperidone ER is well tolerated in Thai patients with schizophrenia. Paliperidone ER showed improvement in schizophrenic symptom control and social functioning.

Objectives:- To evaluate social function and overall improvement of paliperidone ER treatment in Thai schizophrenia patient.- To collect the safety data of Paliperidone ER.Methods:Patients were at least 18 years old and had been diagnosed with schizophrenia according to DSM-IV criteria. Patients were unsatisfied with previous treatment and had been previously or currently on oral atypical antipsychotics. Eligible patients were initiated on a dose of paliperidone ER (3, 6, 9, 12 mg/day) based on tolerability of previous medication. Flexible maintenance dosing during the 10 week study duration was allowed for all participants based on individual tolerability. The primary outcome is social function, determined by Personal and Social Performance Scale (PSP). Patients were also rated for overall severity of illness using Clinical and Global Impressions-Severity (CGI-S) scale.Results:In total, 40 patients were enrolled. The statistical significant improvements from baseline in PSP total score were observed at all time points. An improvement of greater than or equal to 1 category (classified as a10-point interval) on PSP scale is considered as clinical relevant response. Improvement in CGI-S were observed at endpoint (p< 0.001). The mean reduction ± SD at endpoint was for 0.8 ± 1.04 (95% CI 0.48-1.16). The most commonly reported adverse events (3 5% of patients) were daytime drowsiness (15%) and headache (15%). Three subjects (7.5%) discontinued due to adverse events.Conclusion:This study suggests that paliperidone ER is well tolerated in schizophrenic patient. Paliperidone ER showed improvement in schizophrenic symptom control and social functioning.