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Department of Defense PTSD Adaptive Platform Trial - Intervention B - Vilazodone - Trial NCT05948579

Access comprehensive clinical trial information for NCT05948579 through Pure Global AI's free database. This Phase 2 trial is sponsored by U.S. Army Medical Research and Development Command and is currently Not yet recruiting. The study focuses on Post Traumatic Stress Disorder. Target enrollment is 200 participants.

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NCT05948579
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05948579
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Department of Defense PTSD Adaptive Platform Trial - Intervention B - Vilazodone
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

Study Focus

Intervention B Vilazodone Hydrochloride (HCl)

Interventional

drug

Sponsor & Location

U.S. Army Medical Research and Development Command

Timeline & Enrollment

Phase 2

Aug 01, 2023

Sep 01, 2026

200 participants

Primary Outcome

Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit).,Incidence of new or worsening suicidal thoughts or behaviors as measured by change in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline.

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.

ICD-10 Classifications

Post-traumatic stress disorder
Traumatic shock
Personal history of psychological trauma, not elsewhere classified
State of emotional shock and stress, unspecified
Neurotic, stress-related and somatoform disorders

Data Source

ClinicalTrials.gov

NCT05948579

Non-Device Trial