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

Antony Loebel, Josephine Cucchiaro, Robert Silva, Hans Kroger, Jay Hsu, Kaushik Sarma, Gary Sachs
2014 American Journal of Psychiatry  
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
more » ... 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 (215.4; effect size=0.51) and the 80-120 mg/day group (215.4; effect size=0.51) compared with placebo (210.7). Similarly, lurasidone treatment resulted in significantly greater endpoint reduction in CGI-BP depression severity scores for both the 20-60 mg/day group (21.8; effect size=0.61) and the 80-120 mg/day group (21.7; effect size=0.50) compared with placebo (21.1). 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. Am J Psychiatry Loebel et al.; AiA:1-9
doi:10.1176/appi.ajp.2013.13070984 pmid:24170180 fatcat:bs5a4gflbreyve5njohozh2syu