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Department of Defense PTSD Adaptive Platform Trial - Intervention A - Fluoxetine
NCT05948553 · Global Coalition for Adaptive Research
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
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..
Eligibility 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.
Study design
Enrollment target: 200 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2023-11-02
Estimated completion: 2026-09
Last updated: 2025-09-08
Interventions
Drug: Intervention A Fluoxetine Hydrochloride (HCl)Drug: Intervention A Placebo
Primary outcomes
- • Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit). (12 Weeks)
- • Incidence of new or worsening suicidal thoughts or behaviors as measured by change in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline. (12 Weeks)
Sponsor
Global Coalition for Adaptive Research · other
With: U.S. Army Medical Research and Development Command, PPD Development, LP, Berry Consultants, Idorsia Pharmaceuticals Ltd., Cambridge Cognition Ltd, Citeline
Contacts & investigators
ContactPlease visit the website: · contact · ptsdclinicaltrial.org
All locations (10)
Phoenix VA Healthcare SystemRecruiting
Phoenix, Arizona, United States
Homestead Associates in Research, Inc.Recruiting
Miami, Florida, United States
Advanced Discovery ResearchRecruiting
Atlanta, Georgia, United States
Tripler Army Medical Center (TAMC)Recruiting
Tripler AMC, Hawaii, United States
Cincinnati Veteran's Affairs Medical CenterRecruiting
Fort Thomas, Kentucky, United States
Walter Reed National Military Medical Center (WRNMC)Recruiting
Bethesda, Maryland, United States
Upstate Clinical Research Associates, LLCRecruiting
Williamsville, New York, United States
Wilford Hall Ambulatory Surgical Center (WHASC)Recruiting
San Antonio, Texas, United States
Alexander T. Augusta Military Medical Center (ATAMMC):Recruiting
Fort Belvoir, Virginia, United States
Madigan Army Medical CenterRecruiting
Joint Base Lewis McChord, Washington, United States