Department of Defense PTSD Adaptive Platform Trial - Master Protocol
Public ClinicalTrials.gov record NCT05422612. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. Participants are randomized among the available cohorts in the study and the resulting randomization enables sharing/pooling of control participants, where all interventions may be compared to a common control (placebo). The master protocol describes the default procedures and analyses for all cohorts; treatment-specific eligibility requirements, safety and efficacy procedures, or endpoints are described in the cohort-specific appendices and reflected in the intervention-specific clinicaltrials.gov records.
Study identification
- NCT ID
- NCT05422612
- Recruitment status
- Suspended
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 800 participants
Conditions and interventions
Conditions
Interventions
- Intervention A Fluoxetine Hydrochloride (HCl) Drug
- Intervention A Placebo Drug
- Intervention B Vilazodone Hydrochloride (HCl) Drug
- Intervention B Placebo Drug
- Intervention C Daridorexant Drug
- Intervention C Placebo Drug
- Intervention D SLS-002 Drug
- Intervention D Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 1, 2023
- Primary completion
- Jun 30, 2028
- Completion
- Jun 30, 2029
- Last update posted
- Jun 29, 2026
2023 – 2029
United States locations
- U.S. sites
- 9
- U.S. states
- 9
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Homestead Associates in Research, Inc. | Miami | Florida | 33032 | — |
| Advanced Discovery Research | Atlanta | Georgia | 30318 | — |
| Tripler Army Medical Center (TAMC) | Tripler AMC | Hawaii | 96859 | — |
| Cincinnati Veteran's Affairs Medical Center | Fort Thomas | Kentucky | 41075 | — |
| Walter Reed National Military Medical Center (WRNMC) | Bethesda | Maryland | 20889-5632 | — |
| Upstate Clinical Research Associates, LLC | Williamsville | New York | 14221 | — |
| Wilford Hall Ambulatory Surgical Center (WHASC) | San Antonio | Texas | 78236 | — |
| Alexander T. Augusta Military Medical Center (ATAMMC): | Fort Belvoir | Virginia | 22060-5285 | — |
| Madigan Army Medical Center | Joint Base Lewis McChord | Washington | 98433 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05422612, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 29, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05422612 live on ClinicalTrials.gov.