Relapse prevention study of paliperidone extended-release tablets in Chinese patients with schizophrenia》.pdf

Progress in Neuro-Psychopharmacology Biological Psychiatry 53 (2014) 45–53 Contents lists available at ScienceDirect Progress in Neuro-Psychopharmacology Biological Psychiatry journal homepage: /locate/pnp Relapse prevention study of paliperidone extended-release tablets in ☆,☆☆,★ Chinese patients with schizophrenia Qing Rui a,⁎, Yang Wang a, Shu Liang b, Yanning Liu a, Yue Wu a, Qingqi Wu a, Isaac Nuamah c, Srihari Gopal c a Janssen Research Development, China b Peking University Sixth Hospital, Beijing, China c Janssen Research Development, LLC, NJ, USA a r t i c l e i n f o a b s t r a c t Article history: Objectives: The objective of this study was to evaluate the long-term efficacy, safety, and tolerability of Received 11 December 2013 paliperidone extended-release (pali ER), in Chinese patients with schizophrenia. Received in revised form 17 February 2014 Methods: In this parallel-group, relapse prevention, phase-3 study (screening [14-day], pali ER open-label run-in Accepted 17 February 2014 [8-week] and stabilization [6-week] phases, and double-blind (DB) treatment [variable duration], and open-label Available online 24 February 2014 extension phases [24-week]), 136/201 patients with schizophrenia were randomized (1:1) to pali ER (3–12 mg) or placebo during the DB phase. K