At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 90 enrolled
Drug / intervention
Ramelteon +1 moredrug
Likely dose
Ramelteon 8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Randomized, Placebo-Controlled Trial of Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder.
In Brief
A Phase 4 clinical trial evaluating Ramelteon and Placebo for Bipolar Disorder. Completed, enrolled 90 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsTakeda
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
First PostedNov 2007
Primary CompletionMar 2010
Study CompletionMay 2010
TodayJul 2026
First PostedNov 2, 2007
Enrollment StartNov 1, 2007
Primary CompletionMar 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.7 years ago
Interventions
Ramelteondrug
one 8 mg tablet at bedtime for up to 6 months
Placebodrug
one tablet at bedtime for up to 6 months