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

ABSTRACT: To evaluate the effectiveness of lurasidone as maintenance treatment for schizophrenia.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).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.This multicenter, placebo-controlled, randomized withdrawal study demonstrated the efficacy of lurasidone for the maintenance treatment of patients with schizophrenia.

SUBMITTER: Tandon R

PROVIDER: S-EPMC4717319 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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

Tandon Rajiv R Cucchiaro Josephine J Phillips Debra D Hernandez David D Mao Yongcai Y Pikalov Andrei A Loebel Antony A

Journal of psychopharmacology (Oxford, England) 20151208 1

<h4>Objective</h4>To evaluate the effectiveness of lurasidone as maintenance treatment for schizophrenia.<h4>Method</h4>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 endp ...[more]

PMID: 26645209

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Project description:To evaluate the efficacy and safety of lurasidone in acutely symptomatic adolescent patients with schizophrenia.Patients aged 13-17 years were randomly assigned to 6 weeks of double-blind, fixed-dose lurasidone (40 or 80?mg/day) or placebo. Primary and key secondary efficacy measures were change from baseline to week 6 in the Positive and Negative Symptom Scale (PANSS) total score and Clinical Global Impressions-Severity (CGI-S) score, respectively, using mixed model for repeated measurement (MMRM) analysis. The proportion of patients achieving treatment response at endpoint, based on ?20% reduction in PANSS total score, was analyzed using a logistic regression model.Least-squares (LS) mean change in PANSS total score from baseline to week 6 was -18.6 with lurasidone 40?mg/day (N?=?108; p?<?0.001 vs. placebo; effect size?=?0.51), -18.3 with lurasidone 80?mg/day (N?=?106; p?<?0.001 vs. placebo; effect size?=?0.48), and -10.5 with placebo (N?=?112). Similarly, LS mean change in CGI-S score from baseline to week 6 was significantly greater with lurasidone 40?mg/day (-1.0; p?<?0.001; effect size?=?0.49) and 80?mg/day (-0.9; p?=?0.0015; effect size?=?0.45) compared with placebo (-0.5). A significantly higher proportion of patients met responder criteria on lurasidone 40 and 80?mg/day versus placebo (63.9% and 65.1% vs. 42.0%; p?<?0.001 for both comparisons). The rate of study discontinuation was 10.3% in lurasidone-treated and 17.7% in placebo-treated patients. The most common adverse events (incidence ?5% in either lurasidone dose group and at least twice the rate of placebo) for lurasidone 40?mg/day, 80?mg/day, and placebo, respectively, were nausea (12.7%, 14.4%, and 2.7%), somnolence (9.1%, 11.5%, and 5.4%), akathisia (9.1%, 8.7%, and 1.8%), vomiting (8.2%, 6.7%, and 1.8%), and sedation (5.5%, 1.9%, and 1.8%). Treatment with lurasidone was not associated with clinically meaningful effects on body weight, lipids, measures of glycemic control, or prolactin.In this 6-week study, lurasidone at doses of 40 and 80?mg/day demonstrated statistically significant and clinically meaningful symptom improvement in adolescent patients with schizophrenia. Lurasidone was generally well tolerated with few effects on weight and metabolic parameters, consistent with findings in adult patients with schizophrenia.

Dataset Information

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

Publications

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

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