A randomized, placebo-controlled study of adjunctive ramelteon in ambulatory bipolar I disorder with manic symptoms and sleep disturbanceMcElroy, Susan L.a; Winstanley, Erin L.a; Martens, Briana; Patel, Nick C.b; Mori, Nicolea; Moeller, Diannaa; McCoy, Jessicaa; Keck, Paul E.aInternational Clinical Psychopharmacology: January 2011 - Volume 26 - Issue 1 - p 48–53 doi: 10.1097/YIC.0b013e3283400d35 Original Articles Abstract Author Information This study evaluated the efficacy and tolerability of ramelteon in ambulatory bipolar I disorder with manic symptoms and insomnia. Twenty-one outpatients with bipolar I disorder by Diagnostic and Statistical Manual of Mental Disorders, fourth edition criteria with mild-to-moderate manic symptoms and sleep disturbance were randomized to receive either ramelteon (N=10) or placebo (N=11) in an 8-week, double-blind, fixed-dose (8 mg/day) study. Ramelteon and placebo had similar rates of reduction in ratings of symptoms of insomnia, mania, and global severity of illness. However, ramelteon was associated with improvement in a global rating of depressive symptoms. It was also well tolerated and associated with no serious adverse events. The small sample size may have limited the ability of the study to detect potentially clinically important drug–placebo differences. Further studies of ramelteon in subgroups of bipolar patients with sleep disturbance, including those with depression or euthymia, seem indicated. aLindner Center of HOPE, Mason, Ohio and University of Cincinnati College of Medicine, Cincinnati, Ohio bDepartment of Psychiatry & Health Behavior, Medical College of Georgia, Augusta, Georgia, USA Correspondence to Susan L. McElroy, MD, Lindner Center of HOPE, Research Institute, 4075 Old Western Row Road, Mason, Ohio 45040, USA Tel: +1 513 536 0700; fax: +1 513 536 0709; e-mail: email@example.com Received April 9, 2010 Accepted August 31, 2010 © 2011 Lippincott Williams & Wilkins, Inc.