Skip to main content
Full access
New Research
Published Online: 1 February 2014

Lurasidone Monotherapy in the Treatment of Bipolar I Depression: A Randomized, Double-Blind, Placebo-Controlled Study

Abstract

In July 2013, the Food and Drug Administration approved lurasidone for the treatment of bipolar I depression. Two studies discussing its monotherapy and adjunctive use that were pivotal in obtaining this approval are featured in this issue.

Abstract

Objective

The authors evaluated the efficacy and safety of lurasidone in the treatment of patients with major depressive episodes associated with bipolar I disorder.

Method

Patients were randomly assigned to receive double-blind treatment with lurasidone (20–60 mg/day [N=166] or 80–120 mg/day [N=169]) or placebo (N=170) for 6 weeks. 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 scores at week 6 for both the 20–60 mg/day group (−15.4; effect size=0.51) and the 80–120 mg/day group (−15.4; effect size=0.51) compared with placebo (−10.7). Similarly, lurasidone treatment resulted in significantly greater endpoint reduction in CGI-BP depression severity scores for both the 20–60 mg/day group (−1.8; effect size=0.61) and the 80–120 mg/day group (−1.7; effect size=0.50) compared with placebo (−1.1). Both lurasidone groups also experienced significant improvements compared with placebo in anxiety symptoms and in patient-reported measures of quality of life and functional impairment. Discontinuation rates due to adverse events were similar in the 20–60 mg/day (6.6%), 80–120 mg/day (5.9%), and placebo (6.5%) groups. The most frequent adverse events associated with lurasidone were nausea, headache, akathisia, and somnolence. Minimal changes in weight, lipids, and measures of glycemic control were observed with lurasidone.

Conclusion

Monotherapy with lurasidone in the dosage range of 20–120 mg/day significantly reduced depressive symptoms in patients with bipolar I depression. Lurasidone was well tolerated, with few changes in weight or metabolic parameters.

Formats available

You can view the full content in the following formats:

Information & Authors

Information

Published In

Go to American Journal of Psychiatry
Go to American Journal of Psychiatry
American Journal of Psychiatry
Pages: 160 - 168
PubMed: 24170180

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 the Bipolar Clinic and Research Program, Massachusetts General Hospital, Boston.
Josephine Cucchiaro, Ph.D.
From Sunovion Pharmaceuticals, Inc., Fort Lee, N.J., and Marlborough, Mass.; and the Bipolar Clinic and Research Program, Massachusetts General Hospital, Boston.
Robert Silva, Ph.D.
From Sunovion Pharmaceuticals, Inc., Fort Lee, N.J., and Marlborough, Mass.; and the Bipolar Clinic and Research Program, Massachusetts General Hospital, Boston.
Hans Kroger, M.P.H., M.S.
From Sunovion Pharmaceuticals, Inc., Fort Lee, N.J., and Marlborough, Mass.; and the Bipolar Clinic and Research Program, Massachusetts General Hospital, Boston.
Jay Hsu, Ph.D.
From Sunovion Pharmaceuticals, Inc., Fort Lee, N.J., and Marlborough, Mass.; and the Bipolar Clinic and Research Program, Massachusetts General Hospital, Boston.
Kaushik Sarma, M.D.
From Sunovion Pharmaceuticals, Inc., Fort Lee, N.J., and Marlborough, Mass.; and the Bipolar Clinic and Research Program, Massachusetts General Hospital, Boston.
Gary Sachs, M.D.
From Sunovion Pharmaceuticals, Inc., Fort Lee, N.J., and Marlborough, Mass.; and the Bipolar Clinic and Research Program, Massachusetts General Hospital, Boston.

Notes

Presented in part at the 165th annual meeting of the American Psychiatric Association, Philadelphia, May 5–9, 2012; the 51st annual meeting of the American College of Neuropsychopharmacology, Hollywood, Fla., December 2–6, 2012; and the 10th International Conference on Bipolar Disorders, Miami Beach, June 13–16, 2013.
Address correspondence to Dr. Loebel ([email protected]).

Funding Information

Dr. Sachs has been a consultant for Sunovion, Otsuka, Johnson & Johnson, and Grunenthal, has stock/other financial relationship with Collaborative Care Initiative, and is an employee of Bracket. Drs. Loebel, Cucchiaro, Silva, Kroger, Hsu, and Sarma are full-time employees of Sunovion Pharmaceuticals, Inc.This study was sponsored by Sunovion Pharmaceuticals, Inc.

Metrics & Citations

Metrics

Citations

Export Citations

If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download.

For more information or tips please see 'Downloading to a citation manager' in the Help menu.

Format
Citation style
Style
Copy to clipboard

View Options

View options

PDF/ePub

View PDF/ePub

Full Text

View Full Text

Get Access

Login options

Already a subscriber? Access your subscription through your login credentials or your institution for full access to this article.

Personal login Institutional Login Open Athens login
Purchase Options

Purchase this article to access the full text.

PPV Articles - American Journal of Psychiatry

PPV Articles - American Journal of Psychiatry

Not a subscriber?

Subscribe Now / Learn More

PsychiatryOnline subscription options offer access to the DSM-5-TR® library, books, journals, CME, and patient resources. This all-in-one virtual library provides psychiatrists and mental health professionals with key resources for diagnosis, treatment, research, and professional development.

Need more help? PsychiatryOnline Customer Service may be reached by emailing [email protected] or by calling 800-368-5777 (in the U.S.) or 703-907-7322 (outside the U.S.).

Media

Figures

Other

Tables

Share

Share

Share article link

Share