Department of Defense PTSD Adaptive Platform Trial Intervention A - Fluoxetine

• Status: Recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: U.S. Army Medical Research and Development Command
• Collaborators: Berry Consultants; Cambridge Cognition Ltd; Citeline; Idorsia Pharmaceuticals Ltd.; PPD
• Treatments: Fluoxetine

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612).

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.