NCT05422612 Department of Defense PTSD Adaptive Platform Trial - Master Protocol
| NCT ID | NCT05422612 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Global Coalition for Adaptive Research |
| Condition | Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2023-11-02 |
| Primary Completion | 2026-03 |
Trial Parameters
Eligibility Fast-Check
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Brief 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. Participants are randomized among the multiple 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). This master protocol describes the default procedures and analyses for all cohorts; treatment-specific procedures will be described in the Master Protocol cohort-specific appendices. Individual cohorts may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in corresponding intervention-specific clinicaltrials.gov records.
Eligibility Criteria
Inclusion Criteria: A participant must meet all the following criteria to be eligible to participate in this study: 1. Is willing and able to provide written informed consent. 2. ≥18 and \<65 years of age at Screening. 3. Meets Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) criteria for PTSD according to CAPS-5-R, Past Month assessment at Screening and Baseline. 4. The index trauma must have occurred more than 3 months prior to screening. 5. Has a CAPS-5-R, Past Month total score of ≥26 at Screening and Baseline. Note: The CAPS-5 scoring grid will be used to score answers and to calculate the total score to determine eligibility. 6. Is currently serving, or has previously served, in a branch of the US military service (ie, Air Force, Army, Navy, Marine Corps, and Coast Guard including Reserves and National Guard). 7. Agrees to consistently use an acceptable method of birth control as defined in Section 7.4.2 (required for both males and females who are of r