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

NCT05948553 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

  • Post Traumatic Stress Disorder

Interventions

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.

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • PPD Development, LP

    collaborator INDUSTRY

  • Berry Consultants

    collaborator OTHER

  • Idorsia Pharmaceuticals Ltd.

    collaborator INDUSTRY

  • Cambridge Cognition Ltd

    collaborator INDUSTRY

  • Citeline

    collaborator INDUSTRY

  • Global Coalition for Adaptive Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-02
Primary Completion
2028-05-31
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05948553 on ClinicalTrials.gov