Department of Defense PTSD Adaptive Platform Trial - Master Protocol
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 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.
Timeline
- Start
- 2023-11-02
- Primary completion
- 2028-07
- Completion
- 2029-07
Outcome
Outcome not reported
Stopped: “The trial has been temporarily suspended due to administrative issues”
Publications
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daridorexant | Small molecule | 50 mg | — |
| Subject | Fluoxetine | Small molecule | 60 mg | — |
| Subject | SLS-002 | Unknown | 78 mg | Intranasal |
| Subject | Vilazodone | Small molecule | 40 mg | — |