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

Part of paid clinical trials in Miami, Florida.

Sponsor
Global Coalition for Adaptive Research
Study ID
NCT05948553
Phase
PHASE2
Status
Suspended

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Intervention A Fluoxetine Hydrochloride (HCl) — DRUG
    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 — DRUG
    A matching placebo will be administered at 10 to 60 mg daily in the same regimen as the intervention.

Study Details

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.

Key Dates

First listed
Jul 17, 2023
Start date
Nov 2, 2023
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention A: Fluoxetine HCl
  • Placebo Comparator: Intervention A Placebo

Primary Outcome Measure

Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit). [ Time Frame: 12 Weeks ]

Locations (9)

FacilityCityStateZIPSite coordinators
Homestead Associates in Research, Inc.MiamiFlorida33032-
Advanced Discovery ResearchAtlantaGeorgia30318-
Tripler Army Medical Center (TAMC)Tripler AMCHawaii96859-
Cincinnati Veteran's Affairs Medical CenterFort ThomasKentucky41075-
Walter Reed National Military Medical Center (WRNMC)BethesdaMaryland20889-5632-
Upstate Clinical Research Associates, LLCWilliamsvilleNew York14221-
Wilford Hall Ambulatory Surgical Center (WHASC)San AntonioTexas78236-
Alexander T. Augusta Military Medical Center (ATAMMC):Fort BelvoirVirginia22060-5285-
Madigan Army Medical CenterJoint Base Lewis McChordWashington98433-

Find similar trials in Miami, FL

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By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Homestead Associates in Research, Inc.· Miami, FLAdvanced Discovery Research· Atlanta, GATripler Army Medical Center (TAMC)· Tripler AMC, HICincinnati Veteran's Affairs Medical Center· Fort Thomas, KYWalter Reed National Military Medical Center (WRNMC)· Bethesda, MDUpstate Clinical Research Associates, LLC· Williamsville, NY

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