At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 61 enrolled
Drug / intervention
Suvorexant +1 moredrug
Likely dose
Not stated in 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 Adjunctive Suvorexant for Treatment-resistant Insomnia in Patients With Bipolar Disorder
In Brief
A Phase 4 clinical trial evaluating Suvorexant and Placebo for Insomnia and Bipolar Disorder. Completed, enrolled 61 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the efficacy of suvorexant, added to existing medications, for treatment-resistant insomnia in individuals with bipolar disorder. The investigators hypothesize that participants receiving suvorexant for one week will experience significantly greater improvement in sleep duration compared to participants receiving placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia, Bipolar Disorder
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartSep 2015
Primary CompletionMar 2021
TodayJul 2026
First PostedAug 19, 2015
Enrollment StartSep 1, 2015
Primary CompletionMar 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 10.9 years ago
Interventions
Suvorexantdrug
Placebodrug