Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder

Summary

To evaluate the efficacy of ramelteon for treatment of acute depressive episodes associated with Bipolar 1 Disorder.

Timeline

Start

2012-08

Primary completion

2014-08

Completion

2014-09

Outcome

Missed primary endpoint

Stopped (Business): “Business Decision; Terminated due to futility, with no safety concerns (see below)”

registry analysis (superiority or other test); Placebo vs TAK-375SL 0.1 mg; p = 0.783; Least Squares Mean Differences 0.8 (97.5% CI -1.4 to 3.0); NCT01677182 ↗

registry analysis (superiority or other test); Placebo vs TAK-375SL 0.4 mg; p = 0.329; Least Squares Mean Difference -0.4 (97.5% CI -2.6 to 1.7); NCT01677182 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ramelteon	Unknown	—	Other

Indications