title: Safety and efficacy of paliperidone extended-release in Chinese patients with schizophrenia: a 24-week, open-label extension of a randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  The long-term safety, tolerability, and efficacy of paliperidone extended-release (ER) were evaluated in Chinese patients with schizophrenia.
  
  
  METHODS
  Patients (aged ≥18 years) with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, 4th edition criteria) who had completed run-in (8-week), stabilization (6-week), and double-blind (DB) phases (variable) of a phase-3, placebo-controlled study entered this 24-week, open-label extension (OLE) study. These patients, who had either experienced a relapse or remained relapse-free through DB phase of the study, were treated with flexible-dose paliperidone-ER (3-12 mg/day) during the OLE phase. Major safety evaluations included treatment-emergent adverse events (TEAEs) and extrapyramidal symptoms. Efficacy endpoints included changes in Positive and Negative Syndrome Scale total score, Clinical Global Impression-Severity scale, and Personal and Social Performance scale from OLE baseline to OLE endpoint.
  
  
  RESULTS
  Out of 106 patients who entered the OLE phase (placebo: 59, paliperidone-ER: 47), a total of 85 (80%) completed it. Thirty-five (33%) patients experienced at least one TEAE; most common were akathisia, somnolence, nasopharyngitis, and constipation (3.8% each). Serious TEAEs were noted in two patients (completed suicide; schizophrenia worsening). No TEAEs with an onset during the OLE phase led to discontinuation. Extrapyramidal symptoms related-TEAEs were reported in eight (7.5%) patients. Mean (standard deviation) changes in Positive and Negative Syndrome Scale total scores (-10.4 [13.2]), Clinical Global Impression-Severity scores (-0.6 [0.96]) and Personal and Social Performance scores (7.4 [13.2]) from OLE baseline to OLE endpoint showed patients who had been treated with placebo during the DB phase experienced more pronounced improvements.
  
  
  CONCLUSIONS
  In this OLE study, flexibly dosed paliperidone-ER (3-12 mg/day) was tolerable and efficacious in Chinese patients with schizophrenia.
authors.affiliation: Peking University 6th Hospital, Peking University Institute of Mental Health, Key Laboratory of Mental Health, Ministry of Health (Peking University), Beijing, People's Republic of China.
authors.forename: Hongyan
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
authors.forename: Huafang
authors.initials: H
authors.lastname: Li
authors.affiliation: Janssen Research & Development, Shanghai, People's Republic of China.
authors.forename: Yanning
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Janssen Research & Development, Shanghai, People's Republic of China.
authors.forename: Cathy
authors.initials: C
authors.lastname: Wu
authors.affiliation: Janssen Research & Development, Shanghai, People's Republic of China.
authors.forename: Qingqi
authors.initials: Q
authors.lastname: Wu
authors.affiliation: Janssen Research & Development, LLC, Titusville, NJ, USA.
authors.forename: Isaac
authors.initials: I
authors.lastname: Nuamah
authors.affiliation: Xian Mental Health Center, Xian, People's Republic of China.
authors.forename: Jianguo
authors.initials: J
authors.lastname: Shi
authors.affiliation: Department of Psychiatry, Nanjing Brain Hospital, Nanjing, People's Republic of China.
authors.forename: Shiping
authors.initials: S
authors.lastname: Xie
authors.affiliation: Mood Disorders Center, Beijing Anding Hospital, Beijing, People's Republic of China.
authors.forename: Gang
authors.initials: G
authors.lastname: Wang
authors.affiliation: Janssen Research & Development, LLC, Titusville, NJ, USA.
authors.forename: Srihari
authors.initials: S
authors.lastname: Gopal
keywords: CGI-S score; PANSS score; PSP score; paliperidone
references.citation: Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jun 1;35(4):1002-8
references.pmid: 21315787
references.citation: Biol Psychiatry. 2007 Dec 15;62(12):1363-70
references.pmid: 17601495
references.citation: J Psychiatr Res. 2013 Oct;47(10):1370-5
references.pmid: 23791457
references.citation: Psychiatry Res. 2011 Jan 30;185(1-2):275-9
references.pmid: 20542575
references.citation: Schizophr Res. 2007 Feb;90(1-3):147-61
references.pmid: 17092691
references.citation: Schizophr Res. 2007 Jul;93(1-3):117-30
references.pmid: 17466492
references.citation: Int J Epidemiol. 2007 Aug;36(4):758-60
references.pmid: 17566003
references.citation: Schizophr Res. 2013 Jan;143(1):38-43
references.pmid: 23148897
references.citation: Prog Neuropsychopharmacol Biol Psychiatry. 2014 Aug 4;53:45-53
references.pmid: 24576532
references.citation: J Clin Psychiatry. 2008 May;69(5):817-29
references.pmid: 18466043
references.citation: CNS Spectr. 2010 Aug;15(8):506-14
references.pmid: 20703197
references.citation: Lancet. 2013 Sep 14;382(9896):951-62
references.pmid: 23810019
references.citation: Expert Opin Pharmacother. 2010 Oct;11(15):2557-67
references.pmid: 20854185
references.citation: Neuropsychiatr Dis Treat. 2015 Jan 06;11:87-95
references.pmid: 25657581