RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-02
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05948540

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. History of narcolepsy.
  2. 2. History of any treatment with daridorexant.

Contacts and Locations

Study Contact

Please visit the website:
CONTACT
ptsdclinicaltrial.org

Study Locations (Sites)

Phoenix VA Healthcare System
Phoenix, Arizona, 85012-1839
United States
Homestead Associates in Research, Inc.
Miami, Florida, 33032
United States
Advanced Discovery Research
Atlanta, Georgia, 30318
United States
Tripler Army Medical Center (TAMC)
Tripler AMC, Hawaii, 96859
United States
Cincinnati Veteran's Affairs Medical Center
Fort Thomas, Kentucky, 41075
United States
Upstate Clinical Research Associates, LLC
Williamsville, New York, 14221
United States
Wilford Hall Ambulatory Surgical Center (WHASC)
San Antonio, Texas, 78236
United States
Madigan Army Medical Center
Joint Base Lewis McChord, Washington, 98433
United States

Collaborators and Investigators

Sponsor: Global Coalition for Adaptive Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-02
Study Completion Date2026-09

Study Record Updates

Study Start Date2023-11-02
Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

  • Post Traumatic Stress Disorder