200
Participants
Start Date
November 30, 2025
Primary Completion Date
March 31, 2026
Study Completion Date
September 30, 2026
Intervention B Vilazodone Hydrochloride (HCl)
Vilazodone HCl will be administered at 10 mg once daily for 7 days, followed by 20 mg for 7 days, followed by 40 mg for the remainder of the trial. There must be a minimum of 7 days between dosage increases. One reduction in dose due to tolerability will be allowed. After Week 8, dose reduction for tolerability is allowed, but dose increase is not allowed.
Intervention B Placebo
A matching placebo will be administered at 10 to 40 mg daily in the same regimen as the intervention.
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