CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 41 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.

Search/NCT02704754
NCT02704754Phase 4Completed

Suvorexant and Trauma Related Insomnia

Howard University·interventional·Posted Mar 10, 2016·Updated Feb 15, 2023

In Brief

A Phase 4 clinical trial evaluating suvorexant and placebo for Insomnia and Posttraumatic Stress Disorder. Completed, enrolled 41 participants across 1 site.

Detailed Summary

Problems sleeping are common after exposure to highly threatening experiences and can occur with and without a diagnosis of posttraumatic stress disorder (PTSD). Established treatments for PTSD are limited for addressing insomnia and many insomnia treatments appear to be limited in the context of PTSD. Suvorexant is FDA approved for insomnia and among approved drugs has a unique mechanism of action that may be well suited for targetting arousal at night dysregulated by trauma. The investigators will evaluate the efficacy of suvorexant for insomnia that developed in relation to trauma exposure, utilizing a placebo control, and polysomnography to identify biomarkers of response, in a six week trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 10, 2016
Enrollment StartMay 1, 2016
Primary CompletionApr 30, 2021
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 10.3 years ago

Interventions

suvorexantdrug

First in class orexin antagonist recently approved by the FDA for the treatment of insomnia

placeboother

Pill with inactive ingredients