Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder
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
Outcome
Missed primary endpoint
Stopped (Business): “Business Decision; No Safety Concerns”
registry analysis (superiority or other test); Placebo vs Ramelteon SL 0.1 mg; p = 0.518; LS Mean Difference 0.1 (98% CI -2.9 to 3.1) NCT01467700 ↗
registry analysis (superiority or other test); Placebo vs Ramelteon SL 0.4 mg; p = 0.979; LS Mean Difference 2.6 (98% CI -0.4 to 5.7) NCT01467700 ↗
registry analysis (superiority or other test); Placebo vs Ramelteon SL 0.8 mg; p = 0.400; LS Mean Difference -0.3 (99% CI -3.7 to 3.0) NCT01467700 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ramelteon | Unknown | 0.1 mg | Subcutaneous |
| Subject | Ramelteon | Unknown | 0.4 mg | Subcutaneous |
| Subject | Ramelteon | Unknown | 0.8 mg | Subcutaneous |