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Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant

NCT05948540 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Post Traumatic Stress Disorder

Interventions

DRUG

Intervention C Daridorexant

Daridorexant will be administered 50 mg once daily at least 2 hours after the last meal and within 30 minutes of going to bed.

DRUG

Intervention C Placebo

A matching placebo will be administered at 50 mg daily in the same regimen as the intervention.

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • PPD Development, LP

    collaborator INDUSTRY

  • Berry Consultants

    collaborator OTHER

  • Idorsia Pharmaceuticals Ltd.

    collaborator INDUSTRY

  • Cambridge Cognition Ltd

    collaborator INDUSTRY

  • Citeline

    collaborator INDUSTRY

  • Global Coalition for Adaptive Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-02
Primary Completion
2028-04-30
Completion
2029-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05948540 on ClinicalTrials.gov