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Department of Defense PTSD Adaptive Platform Trial - Intervention A - Fluoxetine
Sponsor: Global Coalition for Adaptive Research
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 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2023-11-02
Completion Date
2026-09
Last Updated
2025-09-08
Healthy Volunteers
Yes
Conditions
Interventions
Intervention A Fluoxetine Hydrochloride (HCl)
Fluoxetine will be administered at 10 to 60 mg daily. The initial dose for all participants will be 10 mg daily for 1 week, then increased to 20 mg daily for 2 weeks, then increased to 40 mg daily for 2 weeks, then increased to 60 mg daily for the remainder of the trial. One reduction in dose due to tolerability will be allowed. When a participant's dose is decreased due to tolerability, the dose will not be increased.
Intervention A Placebo
A matching placebo will be administered at 10 to 60 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