Department of Defense PTSD Adaptive Platform Trial - Intervention B - Vilazodone

Sponsor
Global Coalition for Adaptive Research
Study ID
NCT05948579
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Intervention B Vilazodone Hydrochloride (HCl) — DRUG
    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 — DRUG
    A matching placebo will be administered at 10 to 40 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 B - Vilazodone will assess the safety and efficacy of vilzodone 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
Aug 31, 2027
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 B Vilazodone
  • Placebo Comparator: Intervention B 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 ]

Central Contacts

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