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- Title
A double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance of efficacy in patients with schizophrenia.
- Authors
Tandon, Rajiv; Cucchiaro, Josephine; Phillips, Debra; Hernandez, David; Mao, Yongcai; Pikalov, Andrei; Loebel, Antony
- Abstract
<bold>Objective: </bold>To evaluate the effectiveness of lurasidone as maintenance treatment for schizophrenia.<bold>Method: </bold>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).<bold>Results: </bold>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.<bold>Conclusions: </bold>This multicenter, placebo-controlled, randomized withdrawal study demonstrated the efficacy of lurasidone for the maintenance treatment of patients with schizophrenia.
- Subjects
SCHIZOPHRENIA treatment; BLIND experiment; PLACEBOS; LIPID synthesis; GLUCOSE analysis; DRUG therapy for schizophrenia; ANTIPSYCHOTIC agents; COMPARATIVE studies; RESEARCH methodology; MEDICAL cooperation; PSYCHOLOGICAL tests; RESEARCH; SCHIZOPHRENIA; TIME; DISEASE relapse; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; PROPORTIONAL hazards models
- Publication
Journal of Psychopharmacology, 2016, Vol 30, Issue 1, p69
- ISSN
0269-8811
- Publication type
journal article
- DOI
10.1177/0269881115620460