Department of Defense PTSD Adaptive Platform Trial Intervention A - Fluoxetine

Description

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.

Conditions

Post Traumatic Stress Disorder

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Study Overview

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Study Details

Study overview

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.

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

Department of Defense PTSD Adaptive Platform Trial Intervention A - Fluoxetine

Condition
Post Traumatic Stress Disorder
Intervention / Treatment

-

Contacts and Locations

Miami

Homestead Associates in Research, Inc., Miami, Florida, United States, 33032

Atlanta

Advanced Discovery Research, Atlanta, Georgia, United States, 30318

Williamsville

Upstate Clinical Research Associates, LLC, Williamsville, New York, United States, 14221

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

U.S. Army Medical Research and Development Command,

Study Record Dates

2026-09