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

NCT05948579 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: S-21-02 (Vilazodone)
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

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

  A change in PTSD symptom severity from baseline as measured by CAPS-5-R Past Month. The range of the scale is 0-200. The higher the score at baseline, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome.

  12 Weeks

• Incidence of new or worsening suicidal thoughts or behaviors as measured by change in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline.

  The C-SSRS is an assessment of suicidal ideation and behavior in clinical and research settings. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). This 5-item subscale ranges from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent).

  12 Weeks

Secondary Outcomes (8)

• Frequency of treatment-emergent adverse events (TEAEs).

  12 Weeks

• Severity of treatment-emergent adverse events (TEAEs).

  12 Weeks

• Frequency of serious adverse events (SAEs).

  12 Weeks

• Severity of serious adverse events (SAEs).

  12 Weeks

• Relative change from Baseline to Week 12 in the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score.

  12 Weeks

Study Arms (2)

Intervention B Vilazodone

EXPERIMENTAL

Drug: Intervention B Vilazodone Hydrochloride (HCl)

Intervention B Placebo

PLACEBO COMPARATOR

Drug: Intervention B Placebo

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 Vilazodone

Intervention B Placebo DRUG

A matching placebo will be administered at 10 to 40 mg daily in the same regimen as the intervention.

Intervention B Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Participants who have undergone or plans to undergo gender reassignment surgery are not eligible. Participants who are currently undergoing stable hormone replacement therapy are eligible for inclusion in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \. History of treatment for PTSD with vilazodone at doses of 20 to 40 mg daily, for at least 4 weeks.

Sponsors & Collaborators

• Global Coalition for Adaptive Research: lead
• U.S. Army Medical Research and Development Command: collaborator
• PPD Development, LP: collaborator
• Berry Consultants: collaborator
• Idorsia Pharmaceuticals Ltd.: collaborator
• Cambridge Cognition Ltd: collaborator
• Citeline: collaborator

Related Publications (1)

• Viele K. Allocation in platform trials to maintain comparability across time and eligibility. Stat Med. 2023 Jul 20;42(16):2811-2818. doi: 10.1002/sim.9750. Epub 2023 Apr 23.

  PMID: 37088912 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Please visit the website:

CONTACT

ptsdclinicaltrial.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The overall 2-stage randomization scheme will be implemented by an unblinded statistician who is otherwise uninvolved in study operations. Participants will be assigned a study number at Screening (Subject ID). In the first stage of randomization, eligible participants who complete screening will be randomly assigned to an open platform cohort for which they are eligible (both site PIs and participants are aware of the cohort assignment) and, within that cohort, the second stage of randomization is to intervention vs placebo (double-blind) using Interactive Response Technology (IRT). For this APT, participant assignment to a cohort will not be blinded. The tablets/capsules used in the cohorts may not be visually similar between cohorts and blinding to cohort assignment is not necessary to avoid bias. However, within each cohort, participants, site personnel, contract research personnel and the sponsor will be blind to treatment assignment (intervention vs. placebo).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Vilazodone is one of multiple interventions that will be tested in this adaptive platform trial (NCT05422612).

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 17, 2023
• Study Start: November 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09