A double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance of efficacy in patients with schizophrenia. (January 2016)

• Record Type: Journal Article
• Authors: Tandon, Rajiv; Cucchiaro, Josephine; Phillips, Debra; Hernandez, David; Mao, Yongcai; Pikalov, Andrei; Loebel, Antony
• Is Part Of: Journal of psychopharmacology. Volume 30:Number 1(2016:Jan.)
• Page Start: 69
• Page End: 77
• Publication Date: 2016-01
• Subjects: Lurasidone -- schizophrenia -- relapse prevention -- maintenance treatment -- antipsychotic agents -- drug therapy; Psychopharmacology -- Periodicals; 615.78
• DOI: 10.1177/0269881115620460
• Languages: English
• ISSNs: 0269-8811

Abstract

Objective: To evaluate the effectiveness of lurasidone as maintenance treatment for schizophrenia. Method: 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.