Add-On Ramelteon in Bipolar I Disorder With Clinically Significant Sleep Disturbance

Summary

The purpose of this research study is to evaluate the safety and efficacy of ramelteon (Rozerem™) as an add-on treatment for sleep problems in patients with bipolar disorder. This study will determine whether or not the addition of ramelteon to ongoing medication(s) for bipolar disorder is useful in improving sleep.

Timeline

Start

2007-12

Primary completion

2010-09

Completion

2010-12

Publications

• Results McElroy SL, Winstanley EL, Martens B, Patel NC, Mori N, Moeller D, McCoy J, Keck PE Jr. A randomized, placebo-controlled study of adjunctive ramelteon in ambulatory bipolar I disorder with manic symptoms and sleep disturbance. Int Clin Psychopharmacol. 2011 Jan;26(1):48-53. doi: 10.1097/YIC.0b013e3283400d35.

Drugs

Indications