200
Participants
Start Date
November 2, 2023
Primary Completion Date
March 31, 2026
Study Completion Date
September 30, 2026
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.
RECRUITING
Upstate Clinical Research Associates, LLC, Williamsville
RECRUITING
Advanced Discovery Research, Atlanta
RECRUITING
Homestead Associates in Research, Inc., Miami
RECRUITING
Cincinnati Veteran's Affairs Medical Center, Fort Thomas
RECRUITING
Wilford Hall Ambulatory Surgical Center (WHASC), San Antonio
RECRUITING
Tripler Army Medical Center (TAMC), Tripler AMC
RECRUITING
Madigan Army Medical Center, Joint Base Lewis McChord
RECRUITING
Phoenix VA Healthcare System, Phoenix
RECRUITING
Walter Reed National Military Medical Center (WRNMC), Bethesda
RECRUITING
Alexander T. Augusta Military Medical Center (ATAMMC):, Fort Belvoir
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