An open-label, prospective study to evaluate social function and overall improvement of extended-release paliperidone treatment in Thai schizophrenia patients

Abstract

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.

Improvement in social and cognitive functioning associated with paliperidone extended-release treatment in patients with schizophrenia: a 24-week, single arm, open-label study

“…Previous studies have demonstrated that paliperidone ER can significantly improve social functioning, health-related quality of life, and disease severity in patients undergoing treatment for acute schizophrenia 2–4. Second-generation antipsychotics such as paliperidone improve social functioning by reducing psychotic symptoms with fewer adverse interactions than previously developed medications.…”

“…Previous studies have demonstrated that paliperidone ER can significantly improve social functioning, health-related quality of life, and disease severity in patients undergoing treatment for acute schizophrenia. 2 – 4 Second-generation antipsychotics such as paliperidone improve social functioning by reducing psychotic symptoms with fewer adverse interactions than previously developed medications. Furthermore, a systematic review of eleven comparative studies revealed that paliperidone ER resulted in significantly greater improvements in functionality as assessed by the Personal and Social Performance Scale (PSP) than those achieved with comparative antipsychotics, including risperidone, olanzapine, and aripiprazole.…”