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

May 22, 2026 updated by: Global Coalition for Adaptive Research

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, Veterans, and Non-Veteran Civilians With PTSD

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The general structure of this Adaptive Platform Trial (APT) consists of a 30-day Screening Period, a 12-week Platform Treatment Period, and a 4-week Safety Follow-up. The S-21-02 Platform Trial will evaluate the safety and efficacy of multiple investigational products for the treatment of PTSD (see NCT05422612 for Master Protocol information). Participants are randomized among the multiple cohorts in the study and the resulting randomization enables sharing/pooling of control subjects, where all interventions may be compared to a common control (placebo). This record only includes information relevant to the daridorexant cohort.

Once a participant meets all eligibility criteria for the Master Protocol, eligibility for each currently enrolling intervention cohort is assessed. Eligible participants will be randomized with equal probability into a cohort. Participants randomized to the daridorexant cohort are then randomly assigned to receive either daridorexant or placebo (in a ratio of 5:3; intervention:placebo), for the duration of the 12-week treatment period.

Parties interested in having their intervention considered for testing within the M-PACT should contact partners@gcaresearch.org

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33032
        • Recruiting
        • Homestead Associates in Research, Inc.
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Advanced Discovery Research
        • Contact:
    • Hawaii
    • Kentucky
      • Fort Thomas, Kentucky, United States, 41075
        • Recruiting
        • Cincinnati Veteran's Affairs Medical Center
        • Contact:
    • Maryland
      • Bethesda, Maryland, United States, 20889-5632
        • Recruiting
        • Walter Reed National Military Medical Center (WRNMC)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aaron Wolfgang, MD
    • New York
      • Williamsville, New York, United States, 14221
        • Recruiting
        • Upstate Clinical Research Associates, LLC
        • Contact:
    • Texas
      • San Antonio, Texas, United States, 78236
        • Recruiting
        • Wilford Hall Ambulatory Surgical Center (WHASC)
        • Contact:
        • Principal Investigator:
          • Paul Sherman, MD
        • Sub-Investigator:
          • Derrek Hamaoka, MD
    • Virginia
      • Fort Belvoir, Virginia, United States, 22060-5285
        • Recruiting
        • Alexander T. Augusta Military Medical Center (ATAMMC):
        • Contact:
        • Contact:
    • Washington
      • Joint Base Lewis McChord, Washington, United States, 98433
        • Recruiting
        • Madigan Army Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612).

Exclusion Criteria:

The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612).

  1. History of narcolepsy.
  2. History of any treatment with daridorexant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention C Daridorexant
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.
Placebo Comparator: Intervention C Placebo
Drug: Intervention C Placebo
A matching placebo will be administered at 50 mg daily in the same regimen as the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of new or worsening suicidal thoughts or behaviors as measured by change in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline.
Time Frame: 12 Weeks
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
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of treatment-emergent adverse events (TEAEs).
Time Frame: 12 Weeks
The TEAEs recorded during the study will be summarized by system organ class, preferred term, and treatment group. Adverse events and medical history will be coded using the most current version of MedDRA.
12 Weeks
Severity of treatment-emergent adverse events (TEAEs).
Time Frame: 12 Weeks
The TEAEs recorded during the study will be summarized by system organ class, preferred term, and treatment group. Adverse events and medical history will be coded using the most current version of MedDRA.
12 Weeks
Frequency of serious adverse events (SAEs)
Time Frame: 12 Weeks
The SAEs recorded during the study will be summarized by system organ class, preferred term, and treatment group. Adverse events and medical history will be coded using the most current version of MedDRA
12 Weeks
Severity of serious adverse events (SAEs).
Time Frame: 12 Weeks
The SAEs recorded during the study will be summarized by system organ class, preferred term, and treatment group. Adverse events and medical history will be coded using the most current version of MedDRA
12 Weeks
Number of participants with a Response Rate ≥30%
Time Frame: 12 Weeks
≥30% reduction from Baseline to 12 Weeks in the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score. The range of the scale is 0-200. The higher the score, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome.
12 Weeks
Number of participants with a Response Rate ≥50%
Time Frame: 12 Weeks
≥50% reduction from Baseline to 12 Weeks in the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score. The range of the scale is 0-200. The higher the score, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome.
12 Weeks
Number of participants Achieving Remission.
Time Frame: 12 Weeks
Achieving remission: defined as the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score <18. The range of the scale is 0-200. The higher the score, the worse the PTSD severity.
12 Weeks
Relative change from Baseline to Week 12 in CAPS-5-R, Past Month total score.
Time Frame: 12 Weeks
A relative change in PTSD symptom severity from baseline as measured by the Clinician-Administered PTSD Scale for DSM-5 Revised (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
Relative and absolute change from Baseline in Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score at Weeks 4 and 8
Time Frame: 8 Weeks
A relative 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.
8 Weeks
Absolute change from Baseline at each post-Baseline Visit in questionnaires
Time Frame: Week 4, Week 6, Week 8, Week 12, and Week 16, when questionnaires are completed.
Generalized anxiety disorder screener (GAD-7) Timeline follow back (TLFB) for substance use Fagerström Test for Nicotine Dependence (FTND) Brief Inventory of Psychosocial Functioning (B-IPF) An abbreviated version of the World Health Organization Quality of Life (WHOQOL)-100 quality of life assessment (WHOQOL-BREF) Perceived Stress Scale (PSS) Brief Pain Inventory (BPI) Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) (mean average IDSIQ scores for 7-days prior to Weeks 4, 8, and 12)
Week 4, Week 6, Week 8, Week 12, and Week 16, when questionnaires are completed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Global Coalition for Adaptive Research

Collaborators

Idorsia Pharmaceuticals Ltd.
U.S. Army Medical Research and Development Command
Berry Consultants
Cambridge Cognition Ltd
Citeline
PPD Development, LP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2023

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-21-02 (Daridorexant)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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