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Published Online: 1 February 2014

Lurasidone as Adjunctive Therapy With Lithium or Valproate for the Treatment of Bipolar I Depression: A Randomized, Double-Blind, Placebo-Controlled Study

Abstract

Objective

Few studies have been reported that support the efficacy of adjunctive therapy for patients with bipolar I depression who have had an insufficient response to monotherapy with mood-stabilizing agents. The authors investigated the efficacy of lurasidone, a novel antipsychotic agent, as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression.

Method

Patients were randomly assigned to receive 6 weeks of double-blind adjunctive treatment with lurasidone (N=183) or placebo (N=165), added to therapeutic levels of either lithium or valproate. Primary and key secondary endpoints were change from baseline to week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) and depression severity score on the Clinical Global Impressions scale for use in bipolar illness (CGI-BP), respectively.

Results

Lurasidone treatment significantly reduced mean MADRS total score at week 6 compared with the placebo group (−17.1 versus −13.5; effect size=0.34). Similarly, lurasidone treatment resulted in significantly greater endpoint reduction in CGI-BP depression severity scores compared with placebo (−1.96 versus −1.51; effect size=0.36) as well as significantly greater improvement in anxiety symptoms and in patient-reported measures of quality of life and functional impairment. Discontinuation rates due to adverse events were 6.0% and 7.9% in the lurasidone and placebo groups, respectively. Adverse events most frequently reported for lurasidone were nausea, somnolence, tremor, akathisia, and insomnia. Minimal changes in weight, lipids, and measures of glycemic control were observed during treatment with lurasidone.

Conclusions

In patients with bipolar I depression, treatment with lurasidone adjunctive to lithium or valproate significantly improved depressive symptoms and was generally well tolerated.

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Information & Authors

Information

Published In

Go to American Journal of Psychiatry
Go to American Journal of Psychiatry
American Journal of Psychiatry
Pages: 169 - 177
PubMed: 24170221

History

Received: 27 July 2013
Revision received: 9 September 2013
Accepted: 10 September 2013
Published online: 1 February 2014
Published in print: February 2014

Authors

Details

Antony Loebel, M.D.
From Sunovion Pharmaceuticals, Inc., Fort Lee, N.J., and Marlborough, Mass.; and University Hospitals Case Medical Center, Case Western Reserve University, Cleveland.
Josephine Cucchiaro, Ph.D.
From Sunovion Pharmaceuticals, Inc., Fort Lee, N.J., and Marlborough, Mass.; and University Hospitals Case Medical Center, Case Western Reserve University, Cleveland.
Robert Silva, Ph.D.
From Sunovion Pharmaceuticals, Inc., Fort Lee, N.J., and Marlborough, Mass.; and University Hospitals Case Medical Center, Case Western Reserve University, Cleveland.
Hans Kroger, M.P.H., M.S.
From Sunovion Pharmaceuticals, Inc., Fort Lee, N.J., and Marlborough, Mass.; and University Hospitals Case Medical Center, Case Western Reserve University, Cleveland.
Kaushik Sarma, M.D.
From Sunovion Pharmaceuticals, Inc., Fort Lee, N.J., and Marlborough, Mass.; and University Hospitals Case Medical Center, Case Western Reserve University, Cleveland.
Jane Xu, Ph.D.
From Sunovion Pharmaceuticals, Inc., Fort Lee, N.J., and Marlborough, Mass.; and University Hospitals Case Medical Center, Case Western Reserve University, Cleveland.
Joseph R. Calabrese, M.D.
From Sunovion Pharmaceuticals, Inc., Fort Lee, N.J., and Marlborough, Mass.; and University Hospitals Case Medical Center, Case Western Reserve University, Cleveland.

Notes

Address correspondence to Dr. Calabrese ([email protected]).

Funding Information

This study was sponsored by Sunovion Pharmaceuticals, Inc.

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