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Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study.

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Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Loebel, Antony Cucchiaro, Josephine Silva, Robert Kroger, Hans Hsu, Jay Sarma, Kaushik Sachs, Gary
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.
File Format	HTM / HTML
ISSN	0002953X
e-ISSN	15357228
Journal	American Journal of Psychiatry
Issue Number	2
Volume Number	171
Language	English
Publisher	American Psychiatric Association
Publisher Date	2014-02-01
Publisher Place	United States
Access Restriction	Open
Subject Keyword	Discipline Psychiatry Antidepressive Agents Therapeutic Use Bipolar Disorder Drug Therapy Isoindoles Thiazoles Adolescent Adverse Effects Dose-response Relationship, Drug Double-blind Method Lurasidone Hydrochloride Placebos Psychiatric Status Rating Scales Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Psychiatry and Mental Health

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