U.S. Department of Defense Taps Global Coalition for Adaptive Research to be the Regulatory Lead for PTSD Trial

jayfer2 0 Comments February 6, 2025

GCAR Sponsoring Pioneering Phase 2 PTSD Adaptive Platform Trial

Trial Enrolling U.S. Active-Duty Service Members and Veterans

Multiple Treatments to Be Tested for PTSD Symptom Relief

LARKSPUR, Calif., Feb. 6, 2025 /PRNewswire/ — The Global Coalition for Adaptive Research (GCAR) today announced that they are collaborating 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) (NCT05422612) 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.

“Operational Medical Systems has made the strategic decision to collaborate with GCAR, leveraging the strengths of both organizations to support the long-term success of the M-PACT,” said Ms. Bobbie Mortimer, Deputy Project Manager for OPMED’s Warfighter Readiness, Performance and Brain Health Project Management Office (WRPBH PMO). “We are confident that GCAR’s expertise in executing innovative clinical trial designs will significantly accelerate progress and bring us closer to effective treatments for patients with PTSD.”

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.

“At GCAR, our mission is to accelerate the development of life-changing treatments for patients suffering from debilitating conditions like PTSD. We believe adaptive platform trials offer a powerful way to achieve this goal and make a meaningful impact on patients’ lives,” said Meredith Buxton, Ph.D., M.P.H., Chief Executive Officer and President of GCAR. “We are honored to serve as the sponsor of the M-PACT and are committed to advancing the evaluation of promising therapies for PTSD, a condition in need of more effective treatment options.”

While treatments for PTSD, such as trauma-focused psychotherapy and symptom-managing medications, are available, research has shown they tend to be less effective for individuals with a military background compared to non-veteran civilian patients.

“The Department of Defense’s M-PACT study was launched to address this disparity in treatment outcomes by evaluating pharmacotherapeutic interventions specifically for military service members and veterans,” said Kimberly del Carmen, Ph.D., a Product Manager for OPMED’s WRPBH PMO. “This trial is designed to efficiently assess multiple drugs at once, replacing ineffective ones with new candidates as data emerges, while advancing successful treatments 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.

About Global Coalition for Adaptive Research (GCAR)

Global Coalition for Adaptive Research (GCAR) is a 501(c)(3) non-profit corporation uniting physicians, clinical researchers, advocacy and philanthropic organizations, biotech/pharma companies, health authorities, government agencies, and other key stakeholders in healthcare to expedite the discovery and development of treatments for patients with rare and deadly diseases. As the sponsor of innovative trials, including master protocols and adaptive platform trials, GCAR is dedicated to the advancement of science by modernizing clinical trials that support more efficient, less costly drug development. To learn more about GCAR and its initiatives, visit gcaresearch.org and follow us on social media @GCAResearch.