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 and Veterans With PTSD

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.

Description

Eligibility

Age range

18–65 years

Sex

All

Healthy volunteers

Yes

Interventions

• Drug
  Intervention C Daridorexant

  Daridorexant 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 Placebo

  A matching placebo will be administered at 50 mg daily in the same regimen as the intervention.

Locations (10)