title: A double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance of efficacy in patients with schizophrenia.
abstract: OBJECTIVE
  To evaluate the effectiveness of lurasidone as maintenance treatment for schizophrenia.
  
  
  METHODS
  Adults experiencing an acute exacerbation of schizophrenia initially received 12-24 weeks of open-label treatment with lurasidone (40-80 mg/d, flexibly dosed). Patients who maintained clinical stability for ⩾12 weeks were randomized in double-blind fashion to placebo or lurasidone (40-80 mg/d, flexibly dosed) for an additional 28-week treatment period. The primary efficacy endpoint was time to relapse (based on Kaplan-Meier survival analysis).
  
  
  RESULTS
  A total of 676 patients enrolled in the open-label phase; 285 met protocol-specified stabilization criteria and were randomized to lurasidone (N=144) or placebo (N=141). During the open-label phase, mean Positive and Negative Syndrome Scale total score decreased from 90.1 to 54.4 in patients who met clinical stability criteria and were randomized. In the double-blind phase, lurasidone significantly delayed time to relapse compared with placebo (log-rank test, p=0.039), reflecting a 33.7% reduction in risk of relapse (Cox hazard ratio (95% confidence interval), 0.663 (0.447-0.983); p=0.041). Probability of relapse at the double-blind week 28 endpoint (based on Kaplan-Meier analysis) was 42.2% in the lurasidone group and 51.2% in the placebo group. Minimal changes in weight, lipid, glucose, and prolactin were observed throughout the study.
  
  
  CONCLUSIONS
  This multicenter, placebo-controlled, randomized withdrawal study demonstrated the efficacy of lurasidone for the maintenance treatment of patients with schizophrenia.
authors.affiliation: University of Florida College of Medicine, Gainesville, FL, USA tandon@ufl.edu.
authors.forename: Rajiv
authors.initials: R
authors.lastname: Tandon
authors.affiliation: Sunovion Pharmaceuticals Inc., Fort Lee and Marlborough, NJ, USA.
authors.forename: Josephine
authors.initials: J
authors.lastname: Cucchiaro
authors.affiliation: Sunovion Pharmaceuticals Inc., Fort Lee and Marlborough, NJ, USA.
authors.forename: Debra
authors.initials: D
authors.lastname: Phillips
authors.affiliation: Sunovion Pharmaceuticals Inc., Fort Lee and Marlborough, NJ, USA.
authors.forename: David
authors.initials: D
authors.lastname: Hernandez
authors.affiliation: Sunovion Pharmaceuticals Inc., Fort Lee and Marlborough, NJ, USA.
authors.forename: Yongcai
authors.initials: Y
authors.lastname: Mao
authors.affiliation: Sunovion Pharmaceuticals Inc., Fort Lee and Marlborough, NJ, USA.
authors.forename: Andrei
authors.initials: A
authors.lastname: Pikalov
authors.affiliation: Sunovion Pharmaceuticals Inc., Fort Lee and Marlborough, NJ, USA.
authors.forename: Antony
authors.initials: A
authors.lastname: Loebel
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069056:Lurasidone Hydrochloride / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011569:Psychiatric Status Rating Scales; D012008:Recurrence; D012559:Schizophrenia / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D000069056:Lurasidone Hydrochloride
keywords: Lurasidone; antipsychotic agents; drug therapy; maintenance treatment; relapse prevention; schizophrenia