NCT05948553

Department of Defense PTSD Adaptive Platform Trial - Intervention A - Fluoxetine

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Global Coalition for Adaptive Research · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The general structure of this Adaptive Platform Trial (APT) consists of a 30-day Screening Period, a 12-week Platform Treatment Period, and a 4-week Safety Follow-up. The S-21-02 Platform Trial will evaluate the safety and efficacy of multiple investigational products for the treatment of PTSD (see NCT05422612 for Master Protocol information). Participants are randomized among the multiple cohorts in the study and the resulting randomization enables sharing/pooling of control subjects, where all interventions may be compared to a common control (placebo). This record only includes information relevant to the fluoxetine cohort. Once a participant meets all eligibility criteria for the Master Protocol, eligibility for each currently enrolling intervention cohort is assessed. Eligible participants will be randomized with equal probability into a cohort. Participants randomized to the fluoxetine cohort are then randomly assigned to receive either fluoxetine or placebo (in a ratio of 5:3; intervention:placebo), for the duration of the 12-week treatment period. Parties interested in having their intervention considered for testing within the M-PACT should complete a request for information form using this webpage https://citeline.qualtrics.com/jfe/form/SV\_8eTQKw6TNug4z42..

Conditions

• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	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.
DRUG	Intervention A Placebo	A matching placebo will be administered at 10 to 60 mg daily in the same regimen as the intervention.

Timeline

• Start date: 2023-11-02
• Primary completion: 2026-03-01
• Completion: 2026-09-01
• First posted: 2023-07-17
• Last updated: 2025-09-08

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study