An open-label, flexible-dose study of paliperidone extended-release in Chinese patients with first-onset psychosis

Background: Antipsychotic medications facilitate the improvement of psychotic symptoms in patients with first-episode psychosis. Paliperidone extended-release (pali-ER), an atypical antipsychotic, was assessed for efficacy and safety in Chinese patients with first-episode psychosis. Methods: In this 8-week, open-label, single-arm, multicenter study, patients with first-episode psychosis (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria) and a Positive and Negative Syndrome Scale (PANSS) total score >= 70 were treated with flexible-dose pali-ER tablets (3-12 mg/day). The primary efficacy endpoint was the percentage of patients with an increase of >= 8 points in Personal and Social Performance (PSP) score from baseline to day 56 (8 weeks). Secondary endpoints included reduction in PANSS total score, improvement in Clinical Global Impression-Severity score, PSP score, Subjective Well-being under Neuroleptics Scale score, and relationship between duration of untreated psychosis and PANSS or PSP. Incidences of treatment-emergent adverse events were used to evaluate safety. Results: Overall, 283 of 294 patients (96%) achieved a >= 8-point increase in PSP (primary endpoint, analysis set). For the secondary efficacy endpoints, 284/306 patients (93%) had a >= 30% reduction in PANSS total score; 266/306 patients (87%) achieved a <= 3 Clinical Global Impression-Severity scale score, and 218/294 patients (74%) had a PSP score >= 71. The Subjective Well-being under Neuroleptics Scale score was improved from a baseline mean of 72.7 to 94.7 at endpoint. There was a negative correlation between duration of untreated psychosis and posttreatment PSP score and a positive correlation with posttreatment PANSS total score. The most common treatment-emergent adverse events were extrapyramidal symptoms (12%), and agitation, somnolence, and xerostomia (4% each). Conclusion: An 8-week, flexible-dose (3-12 mg/day) treatment with pali-ER resulted in significant improvements in psychotic symptoms and was generally tolerable.