Post Traumatic Stress DisorderPhase 2NCT05948540
Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant
A Phase 2 study testing Intervention C Daridorexant in people with Post Traumatic Stress Disorder, run by Global Coalition for Adaptive Research at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Intervention C Daridorexant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 9 sitesUnited States
- Study dates
- 2 Nov 2023to Jul 2029
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612).
Who cannot join
- The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612).
- History of narcolepsy.
- History of any treatment with daridorexant.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Advanced Discovery Research
Atlanta, Georgia, 30318
Walter Reed National Military Medical Center (WRNMC)
Bethesda, Maryland, 20889-5632
Alexander T. Augusta Military Medical Center (ATAMMC):
Fort Belvoir, Virginia, 22060-5285
Cincinnati Veteran's Affairs Medical Center
Fort Thomas, Kentucky, 41075
Madigan Army Medical Center
Joint Base Lewis McChord, Washington, 98433
Homestead Associates in Research, Inc.
Miami, Florida, 33032
Wilford Hall Ambulatory Surgical Center (WHASC)
San Antonio, Texas, 78236
Tripler Army Medical Center (TAMC)
Tripler AMC, Hawaii, 96859
Upstate Clinical Research Associates, LLC
Williamsville, New York, 14221
About this study
Official title: 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.
Read the 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
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Intervention C Daridorexant, Intervention C Placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention C DaridorexantDrug
Daridorexant will be administered 50 mg once daily at least 2 hours after the last meal and within 30 minutes of going to bed.
Intervention C PlaceboDrug
A matching placebo will be administered at 50 mg daily in the same regimen as the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention C Daridorexant | Experimental | Not described Receives: Drug: Intervention C Daridorexant |
| Intervention C Placebo | Placebo comparator | Not described Receives: Drug: Intervention C Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 12 Weeks
Secondary outcomes (10)
Frequency of treatment-emergent adverse events (TEAEs).
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.
Measured: 12 Weeks
Severity of treatment-emergent adverse events (TEAEs).
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.
Measured: 12 Weeks
Frequency of serious adverse events (SAEs)
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
Measured: 12 Weeks
Severity of serious adverse events (SAEs).
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
Measured: 12 Weeks
Relative change from Baseline to Week 12 in CAPS-5-R, Past Month total score.
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.
Measured: 12 Weeks
Number of participants with a Response Rate ≥30%
≥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.
Measured: 12 Weeks
Number of participants with a Response Rate ≥50%
≥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.
Measured: 12 Weeks
Number of participants Achieving Remission.
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.
Measured: 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
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.
Measured: 8 Weeks
Absolute change from Baseline at each post-Baseline Visit in questionnaires
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)
Measured: Week 4, Week 6, Week 8, Week 12, and Week 16, when questionnaires are completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start2 Nov 2023
- Primary completionApr 2028 (estimated)
- Study completionJul 2029 (estimated)
Why it stopped: The trial has been temporarily suspended due to administrative issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Daridorexant is one of multiple interventions that will be tested in this adaptive platform trial (NCT05422612).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global Coalition for Adaptive Research
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, PPD Development, LP, Berry Consultants, Idorsia Pharmaceuticals Ltd., Cambridge Cognition Ltd, Citeline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948540
- Sponsor's protocol ID
- S-21-02 (Daridorexant)
- Status last verified
- May 2026
- First submitted
- 5 Jul 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 37088912
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05948540
- Acronym / sponsor ID
- S-21-02 (Daridorexant)
- Conditions
- Post Traumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The trial has been temporarily suspended due to administrative issues
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Global Coalition for Adaptive ResearchUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, PPD Development, LP, Berry Consultants, Idorsia Pharmaceuticals Ltd., Cambridge Cognition Ltd, Citeline
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Daridorexant is one of multiple interventions that will be tested in this adaptive platform trial (NCT05422612).
| Arm | Type | Receives |
|---|---|---|
| Intervention C Daridorexant | Experimental | Drug: Intervention C Daridorexant |
| Intervention C Placebo | Placebo comparator | Drug: Intervention C Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612).
Key exclusion criteria (3 listed)
- The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612).
- History of narcolepsy.
- History of any treatment with daridorexant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention C DaridorexantDaridorexant 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 Daridorexant |
| Intervention C PlaceboA matching placebo will be administered at 50 mg daily in the same regimen as the intervention. | Drug | Intervention C Placebo |
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).
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.
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).
10 secondary outcomes
Frequency of treatment-emergent adverse events (TEAEs).
Time frame: 12 Weeks
Severity of treatment-emergent adverse events (TEAEs).
Time frame: 12 Weeks
Frequency of serious adverse events (SAEs)
Time frame: 12 Weeks
Severity of serious adverse events (SAEs).
Time frame: 12 Weeks
Relative change from Baseline to Week 12 in CAPS-5-R, Past Month total score.
Time frame: 12 Weeks
Number of participants with a Response Rate ≥30%
Time frame: 12 Weeks
Number of participants with a Response Rate ≥50%
Time frame: 12 Weeks
Number of participants Achieving Remission.
Time frame: 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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Background: PubMed 37088912Viele 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intervention C Daridorexant in people with Post Traumatic Stress Disorder, run by Global Coalition for Adaptive Research at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05948540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.