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

Phase 3 Terminated 21 enrolled Lindner Center of HOPE Takeda · collab University of Cincinnati · collab

RandomizedParallel-groupQuadruple-blindTreatment

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

Outcome

Outcome not reported

Stopped: “sponsor terminated study”

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

Evaluation	Drug	Modality	Dose	Route
Comparator	Ramelteon	Unknown	8 mg	—