Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder

Summary

The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in adult patients.

Timeline

Start

2011-12

Primary completion

2015-03

Completion

2015-03

Outcome

Missed primary endpoint

Stopped (Business): “Business Decision; No Safety Concerns.”

paper No significant differences between any dose of ramelteon SL and placebo were observed. PMID 28662460 ↗

registry analysis (superiority or other test); Placebo vs Ramelteon SL 0.1 mg; p = 0.286; Hazard Ratio (HR) 0.77 (98.3% CI 0.42 to 1.39); Log Rank NCT01467713 ↗

paper The study failed to demonstrate the efficacy of ramelteon SL as adjunctive maintenance therapy for bipolar disorder. PMID 28662460 ↗

Publications

• Mahableshwarkar AR, Calabrese JR, Macek TA, Budur K, Adefuye A, Dong X, Hanson E, Sachs GS. Efficacy and safety of sublingual ramelteon as an adjunctive therapy in the maintenance treatment of bipolar I disorder in adults: A phase 3, randomized controlled trial. J Affect Disord. 2017 Oct 15;221:275-282. doi: 10.1016/j.jad.2017.06.044. Epub 2017 Jun 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ramelteon	Unknown	0.1 mg	Other
Subject	Ramelteon	Unknown	0.4 mg	Other
Subject	Ramelteon	Unknown	0.8 mg	Other

Indications