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Recruiting Phase 2 NCT05948540
Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant
Trial Parameters
Condition Post Traumatic Stress Disorder
Sponsor Global Coalition for Adaptive Research
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2023-11-02
Completion 2026-03
Interventions
Intervention C DaridorexantIntervention C Placebo
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. 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.
Eligibility Criteria
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.
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