Department of Defense PTSD Adaptive Platform Trial - Intervention A - Fluoxetine
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 A - Fluoxetine will assess the safety and efficacy of fluoxetine in participants with PTSD. Please see NCT05422612 for information on the S-21-02 Master Protocol.
Key facts
- Study ID
- NCT05948553
- Run by
- Global Coalition for Adaptive Research
- People needed
- 200
- Starts
- 2023-11-02
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-05-20
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).
- Recent history of treatment for PTSD with fluoxetine at doses of 20 mg daily, for at least 4 weeks. A remote history of treatment with fluoxetine for non-PTSD symptoms will be discussed on a case-by-case basis with the contract research organization (CRO) Medical Monitor.
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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