Department of Defense PTSD Adaptive Platform Trial - Intervention A - Fluoxetine
NCT ID: NCT05948553
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2023-11-02
2026-09-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
For this APT, participants assignment to a cohort will not be blinded. The tablets/capsules used in the cohorts may not be visually similar between cohorts and blinding to cohort assignment is not necessary to avoid bias. However, within each cohort, participants, site personnel, contract research personnel and the sponsor will be blind to treatment assignment (intervention vs. placebo).
Study Groups
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Intervention A: Fluoxetine HCl
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.
Intervention A Placebo
Intervention A Placebo
A matching placebo will be administered at 10 to 60 mg daily in the same regimen as the intervention.
Interventions
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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.
Intervention A Placebo
A matching placebo will be administered at 10 to 60 mg daily in the same regimen as the intervention.
Eligibility Criteria
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Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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U.S. Army Medical Research and Development Command
FED
PPD Development, LP
INDUSTRY
Berry Consultants
OTHER
Idorsia Pharmaceuticals Ltd.
INDUSTRY
Cambridge Cognition Ltd
INDUSTRY
Citeline
INDUSTRY
Global Coalition for Adaptive Research
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Please visit the website:
Role: CONTACT
Facility Contacts
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Dr. Shabnam Thompson
Role: primary
References
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Viele K. Allocation in platform trials to maintain comparability across time and eligibility. Stat Med. 2023 Jul 20;42(16):2811-2818. doi: 10.1002/sim.9750. Epub 2023 Apr 23.
Other Identifiers
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S-21-02 (Fluoxetine)
Identifier Type: -
Identifier Source: org_study_id
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