A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375 (Ramelteon) Tablet for Sublingual Administration (TAK-375SL Tablet) 0.1 mg, 0.4 mg, and 0.8 mg in the Treatment of Acute Depressive Episodes Associated with Bipolar I Disorder in Adult Patients who are on Lithium and/or Valproate
The purpose of this study is to determine if a new formulation of ramelteon (TAK-375SL) is effective in decreasing the symptoms of depression associated with bipolar I disorder. 18 -75 years old and on stable dose of mood stabilizer and in depressive episode. Participation will be upto 13 weeks with total of 10 study visits to Duke study center. Compensation will be upto $315.00.
For more information, contact Nabila Lateef at 919-684-9701.