title: Relapse prevention study of paliperidone extended-release tablets in Chinese patients with schizophrenia.
abstract: OBJECTIVE
  The objective of this study was to evaluate the long-term efficacy, safety, and tolerability of paliperidone extended-release (pali ER), in Chinese patients with schizophrenia.
  
  
  METHODS
  In this parallel-group, relapse prevention, phase-3 study (screening [14-day], pali ER open-label run-in [8-week] and stabilization [6-week] phases, and double-blind (DB) treatment [variable duration], and open-label 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.
  
  
  RESULTS
  Final analysis showed that, out of 135 patients in ITT (DB) population, 71 (52.6%) had a relapse event, 45 (33.3%) were ongoing at the time the study was stopped, and 19 (14.1%) discontinued from the DB phase. Time to relapse (primary endpoint) favored pali ER (hazard ratio=5.23 [95% CI: 2.96, 9.25], p <0.0001). Rate of relapses (55/71 [77.5%] placebo; 16/64 [25%] pali ER) and secondary endpoints (change from baseline in Positive And Negative Syndrome Scale [PANSS] and Clinical Global Impression - Severity Scores) were significantly lower (p<0.001) in pali ER group vs placebo, in favor of pali ER. More psychiatric-related treatment-emergent adverse events (TEAEs) occurred in placebo- (21.1%) than pali ER group (10.9%). Most common (>3%) TEAEs in placebo group were insomnia and schizophrenia (8.5% each), while in pali ER group were aggression and akathisia (4.7% each), and schizophrenia, tremor, nausea, amenorrhea, and salivary hypersecretion (3.1% each). All serious TEAEs were psychiatric-related (schizophrenia, aggression, completed suicide, auditory hallucination, suicide attempt) and more frequent in placebo- (11.3%) versus pali ER group (3.1%). Death and tardive dyskinesia-related discontinuation (n=1 each) occurred in placebo group. Body weight increase from run-in baseline was greater in pali ER group (mean increase: 3.90 kg) versus placebo (mean increase: 2.05 kg).
  
  
  CONCLUSIONS
  This study confirms the findings from earlier pali ER global relapse-prevention studies and demonstrates that pali ER treatment (3-12 mg) is efficacious over the long-term and significantly delays relapse in Chinese patients with schizophrenia. No new safety signals were detected in this population.
authors.affiliation: Janssen Research & Development, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Rui
authors.affiliation: Janssen Research & Development, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Peking University Sixth Hospital, Beijing, China.
authors.forename: Shu
authors.initials: S
authors.lastname: Liang
authors.affiliation: Janssen Research & Development, China.
authors.forename: Yanning
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Janssen Research & Development, China.
authors.forename: Yue
authors.initials: Y
authors.lastname: Wu
authors.affiliation: Janssen Research & Development, China.
authors.forename: Qingqi
authors.initials: Q
authors.lastname: Wu
authors.affiliation: Janssen Research & Development, LLC, NJ, USA.
authors.forename: Isaac
authors.initials: I
authors.lastname: Nuamah
authors.affiliation: Janssen Research & Development, LLC, NJ, USA.
authors.forename: Srihari
authors.initials: S
authors.lastname: Gopal
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000704:Analysis of Variance; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D044466:Asian People; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D000068882:Paliperidone Palmitate; D016016:Proportional Hazards Models; D011743:Pyrimidines / Q000627:therapeutic use*; D012008:Recurrence; D012559:Schizophrenia / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D007555:Isoxazoles; D011743:Pyrimidines; D000068882:Paliperidone Palmitate
keywords: Chinese; Paliperidone; Schizophrenia; Symptoms; Time to relapse