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
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
• No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612).
Locations
United States
Arizona
Phoenix VA Healthcare System
RECRUITING
Phoenix
Florida
Homestead Associates in Research, Inc.
RECRUITING
Miami
Georgia
Advanced Discovery Research
RECRUITING
Atlanta
Hawaii
Tripler Army Medical Center (TAMC)
RECRUITING
Tripler Amc
Kentucky
Cincinnati Veteran's Affairs Medical Center
RECRUITING
Fort Thomas
Maryland
Walter Reed National Military Medical Center (WRNMC)
RECRUITING
Bethesda
New York
Upstate Clinical Research Associates, LLC
RECRUITING
Williamsville
Texas
Wilford Hall Ambulatory Surgical Center (WHASC)
RECRUITING
San Antonio
Virginia
Alexander T. Augusta Military Medical Center (ATAMMC):
RECRUITING
Fort Belvoir
Washington
Madigan Army Medical Center
RECRUITING
Joint Base Lewis Mcchord
Contact Information
Primary
Please visit the website:
ptsdclinicaltrial.org
Time Frame
Start Date: 2023-11-02
Estimated Completion Date: 2026-09
Participants
Target number of participants: 200
Treatments
Experimental: Intervention A: Fluoxetine HCl
Placebo_comparator: Intervention A Placebo
Related Therapeutic Areas
Sponsors
Collaborators: Citeline, Cambridge Cognition Ltd, PPD Development, LP, Idorsia Pharmaceuticals Ltd., Berry Consultants, U.S. Army Medical Research and Development Command
Leads: Global Coalition for Adaptive Research