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

Paused · Phase 2 · Has a placebo group

Conditions studied: Post Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT05948540

Run by

Global Coalition for Adaptive Research

People needed

200

Starts

2023-11-02

Expected to finish

2029-07-01

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612).

You may not qualify if…

• The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612).
• History of narcolepsy.
• History of any treatment with daridorexant.

Where it is running

• 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

Full record on ClinicalTrials.gov

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