Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant - Trial NCT05948540
Access comprehensive clinical trial information for NCT05948540 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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Study Focus
Sponsor & Location
U.S. Army Medical Research and Development Command
Timeline & Enrollment
Phase 2
Aug 01, 2023
Sep 01, 2026
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 C - Daridorexant will assess the safety and efficacy of daridorexant in
 participants with PTSD.
 
 Please see NCT05422612 for information on the S-21-02 Master Protocol.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05948540
Non-Device Trial