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EPA-1722 – A Double-blind, Placebo-controlled, Randomized Withdrawal Study of lurasidone for the Maintenance of Efficacy in Patients with Schizophrenia

Published online by Cambridge University Press:  15 April 2020

R. Tandon ,
A. Loebel ,
D. Phillips ,
A. Pikalov ,
D. Hernandez ,
Y. Mao  and
J. Cucchiaro
R. Tandon
Affiliation:
Psychiatry, University of Florida College of Medicine, Gainesville, USA
A. Loebel
Affiliation:
Research and Development, Sunovion Pharmaceuticals Inc., Fort Lee, USA
D. Phillips
Affiliation:
Clinical Operations, Sunovion Pharmaceuticals, Fort Lee, USA
A. Pikalov
Affiliation:
Clinical Development and Medical Affairs, Sunovion Pharmaceuticals, Fort Lee, USA
D. Hernandez
Affiliation:
Clinical Operations, Sunovion Pharmaceuticals, Fort Lee, USA
Y. Mao
Affiliation:
Biostatistics, Sunovion Pharmaceuticals, Fort Lee, USA
J. Cucchiaro
Affiliation:
Clinical Operations, Sunovion Pharmaceuticals, Fort Lee, USA

Abstract

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Introduction

Schizophrenia is a chronic disease; consequently, long-term maintenance of efficacy is an important clinical goal.

Objective

To evaluate lurasidone as maintenance treatment for schizophrenia.

Aims

To demonstrate maintenance of efficacy with lurasidone.

Methods

Adult patients experiencing an acute exacerbation of schizophrenia received 12–24 weeks of open-label treatment with lurasidone (40–80 mg/d, flexibly dosed). Those who maintained clinical stability for ≥12 weeks were randomized to placebo or lurasidone (40–80 mg/d, flexibly dosed) and entered the 28-week, double-blind withdrawal phase.

Results

Of 676 enrolled patients, 285 met protocol-specified stabilization criteria and were randomized to lurasidone (N=144) or placebo (N=141). Relapse occurred in a greater proportion of patients receiving placebo (41.1%) than lurasidone (29.9%). Time to relapse based on Kaplan-Meier survival analysis was significantly longer for lurasidone compared with placebo (log-rank test, p=0.039). Lurasidone was associated with a 33.7% reduction in risk of relapse versus placebo (Cox hazard ratio [95% confidence interval], 0.663 [0.447, 0.983]; p=0.041). Patients receiving placebo demonstrated significantly greater worsening on PANSS and CGI-S scores compared to lurasidone-treated patients (PANSS mean change, +12.4 vs +8.3, p=0.029; CGI-S mean change, +0.7 vs +0.4, p=0.015; ANCOVA-LOCF). The discontinuation rate due to adverse events was 13.9% for lurasidone and 15.6% for placebo. Minimal changes in weight, prolactin, lipid, and glucose parameters were observed.

Conclusion

This study demonstrated the efficacy of lurasidone for the maintenance treatment of patients with schizophrenia. Lurasidone was generally well tolerated, with minimal effects on weight and other metabolic parameters.

Study sponsored by Sunovion Pharmaceuticals Inc.

ClinicalTrials.gov identifier: NCT01435928

Type
E01 - e-Poster Oral Session 01: Schizophrenia
Information
European Psychiatry , Volume 29 , Issue S1: Abstracts of the 22nd European Congress of Psychiatry , 2014 , pp. 1
Copyright
Copyright © European Psychiatric Association 2014
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