Global Coalition for Adaptive Research (GCAR) is partnering with Operational Medical Systems, part of the Defense Health Agency, to conduct an adaptive platform trial that is evaluating multiple pharmacotherapeutic interventions for the treatment of posttraumatic stress disorder (PTSD). The Military and Veterans PTSD Adaptive Platform Clinical Trial (M-PACT) is recruiting active-duty service members and veterans with PTSD at multiple clinical sites and is supported by a project team that includes representatives from the U.S. Air Force, Army, Navy, and Special Operations Command.
PTSD is a mental health condition that can develop after someone experiences or is exposed to a traumatic event. Symptoms of PTSD may include, but are not limited to, nightmares, unwanted memories of the trauma, avoidance of situations that bring back memories of the trauma, difficulty sleeping, irritability, or depressed mood.
According to the U.S. Department of Veterans Affairs’ National Center for PTSD, approximately 13 million Americans experienced PTSD in 2020.
Veterans are more likely than civilians to have PTSD, which affects approximately 7 out of every 100 veterans.
Additionally, military veterans who deployed to a war zone are more likely to have PTSD than those who did not deploy.
Despite available treatments for PTSD, which include trauma-focused psychotherapy and medications to manage symptoms, research has shown that these treatments are less effective for people with a military history compared to non-veteran civilian patients.
The Department of Defense M-PACT was launched to address this disparity in treatment outcomes by rapidly evaluating pharmacotherapeutic interventions for the treatment of PTSD experienced by military service members and veterans. The trial is designed to efficiently evaluate multiple drugs simultaneously against a common control. As data from the trial accrues, ineffective drugs will be replaced by new drugs and successful drugs will move to the next phase of development.
Furthermore, the trial will gather data on several biological indicators to determine whether military personnel and veterans with PTSD have any shared biological characteristics that can reveal new targets for future drug development or patient-treatment matching.
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
ClinicalTrials.gov ID: NCT05422612
USAMMDA News Release: Study seeks new treatments for post-traumatic stress disorder in veterans, military personnel
If you or someone you know has suicidal thoughts, get help right away:
- In the U.S., call or text 988 to reach the 988 Suicide & Crisis Lifeline, available 24 hours a day, seven days a week. Or use the Lifeline Chat. Services are free and confidential.
- U.S. veterans or service members who are in crisis can call 988 and then press “1” for the Veterans Crisis Line. Or text 838255. Or chat online.
- The Suicide & Crisis Lifeline in the U.S. has a Spanish language phone line at 1-888-628-9454 (toll-free).