Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant

Launched by GLOBAL COALITION FOR ADAPTIVE RESEARCH · Jul 5, 2023

Keywords

ClinConnect Summary

This clinical trial, called the Department of Defense PTSD Adaptive Platform Trial, is studying a medication named daridorexant to see if it can help people with Post Traumatic Stress Disorder (PTSD). It is a Phase 2 study, meaning researchers are testing the drug on participants to learn more about its safety and effectiveness. The trial is designed to adapt as it progresses, which allows researchers to evaluate multiple treatments at the same time. Participants in this study will be randomly assigned to receive either daridorexant or a placebo (a harmless pill that looks like the drug but has no active ingredients) without knowing which one they are taking.

The trial is open to people aged between 65 and 74, as well as younger participants aged 23 to 40, regardless of gender. To join, participants must not have a history of narcolepsy (a sleep disorder) or have previously been treated with daridorexant. If you choose to participate, you can expect regular check-ups and assessments to monitor your health and how you are responding to the treatment. This study is currently recruiting participants, so it’s a great opportunity to contribute to research that may improve treatment options for PTSD.

Gender

ALL

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.