RecruitingPhase 2NCT05948540

Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant

A Phase 2, Multi-center, Multi-arm, Randomized, Placebo-controlled, Double-blind, Adaptive Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Potential Pharmacotherapeutic Interventions in Active-Duty Service Members and Veterans With PTSD


Sponsor

Global Coalition for Adaptive Research

Enrollment

200 participants

Start Date

Nov 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design. Intervention C - Daridorexant will assess the safety and efficacy of daridorexant in participants with PTSD. Please see NCT05422612 for information on the S-21-02 Master Protocol.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is part of a larger US Department of Defense trial testing treatments for PTSD (post-traumatic stress disorder) in military personnel and veterans. This specific arm is testing daridorexant — a sleep medication that works by blocking signals that keep the brain awake — to see if it helps with PTSD symptoms, particularly sleep disturbances. **You may be eligible if...** - You meet the general eligibility criteria for the master PTSD trial (NCT05422612), which typically includes being a military service member or veteran with a PTSD diagnosis - You have not previously been diagnosed with or treated for narcolepsy - You have never taken daridorexant before **You may NOT be eligible if...** - You have a history of narcolepsy - You have previously been treated with daridorexant - You do not meet the general criteria of the master PTSD trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntervention C Daridorexant

Daridorexant will be administered 50 mg once daily at least 2 hours after the last meal and within 30 minutes of going to bed.

DRUGIntervention C Placebo

A matching placebo will be administered at 50 mg daily in the same regimen as the intervention.


Locations(10)

Phoenix VA Healthcare System

Phoenix, Arizona, United States

Homestead Associates in Research, Inc.

Miami, Florida, United States

Advanced Discovery Research

Atlanta, Georgia, United States

Tripler Army Medical Center (TAMC)

Tripler AMC, Hawaii, United States

Cincinnati Veteran's Affairs Medical Center

Fort Thomas, Kentucky, United States

Walter Reed National Military Medical Center (WRNMC)

Bethesda, Maryland, United States

Upstate Clinical Research Associates, LLC

Williamsville, New York, United States

Wilford Hall Ambulatory Surgical Center (WHASC)

San Antonio, Texas, United States

Alexander T. Augusta Military Medical Center (ATAMMC):

Fort Belvoir, Virginia, United States

Madigan Army Medical Center

Joint Base Lewis McChord, Washington, United States

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NCT05948540


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