drugset / Trial / NCT01467700

Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder

NCT01467700

Phase 3 Terminated 490 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine the efficacy and safety of Ramelteon, once daily (QD), sublingual (SL), in adult participants with acute depressive episodes associated with Bipolar I disorder.

Timeline

Start
2011-12
Primary completion
2015-03
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ramelteon Unknown 0.1 mg Subcutaneous
Subject Ramelteon Unknown 0.4 mg Subcutaneous
Subject Ramelteon Unknown 0.8 mg Subcutaneous

Indications