RecruitingPhase 2NCT05948553

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


Sponsor

Global Coalition for Adaptive Research

Enrollment

200 participants

Start Date

Nov 2, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is part of a larger US Department of Defense trial testing treatments for PTSD in military service members and veterans. This specific arm tests fluoxetine (Prozac) — a commonly used antidepressant — to see how well it reduces PTSD symptoms in this population. **You may be eligible if...** - You meet the general eligibility criteria for the master PTSD trial (NCT05422612), which typically includes being a military service member or veteran with a PTSD diagnosis - You have not recently been treated with fluoxetine specifically for PTSD at a standard dose (20 mg daily for at least 4 weeks) **You may NOT be eligible if...** - You recently received fluoxetine at 20 mg/day for at least 4 weeks for PTSD treatment - You do not meet the general criteria of the master PTSD trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntervention 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.

DRUGIntervention 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

View Full Details on ClinicalTrials.gov

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NCT05948553


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