The US Defense Health Agency (DHA) has initiated a pioneering platform trial in collaboration with the Global Coalition for Adaptive Research (GCAR) to evaluate multiple therapeutic options for post-traumatic stress disorder (PTSD) in military personnel and veterans.
The Military and Veterans PTSD Adaptive Platform Clinical Trial (M-PACT) represents a significant advancement in PTSD research, employing a Phase II randomized, double-blinded, placebo-controlled design to assess three distinct pharmacological interventions over 12 weeks.
Trial Design and Interventions
The study is structured with three parallel treatment arms, each compared against placebo controls. Cohort A will receive Prozac at doses ranging from 10mg to 60mg. The second arm will test Merck's Viibryd (vilazodone), while the third cohort will be administered Idorsia's insomnia medication Quviviq (daridorexant) at a daily dose of 50mg.
Primary Endpoints and Measurements
The trial's effectiveness will be evaluated through two primary endpoints. The first measures changes in PTSD symptom severity using the Clinician-Administered PTSD Scale-5-Revised system, which employs a 1-200 point scale. The second endpoint focuses on monitoring changes in suicidal ideation or behaviors through the Columbia Suicide Severity Rating Scale.
Biological Insights and Future Development
Beyond immediate therapeutic outcomes, the trial aims to identify biological markers common among military personnel and veterans with PTSD. These insights could prove invaluable for future drug development efforts, potentially leading to more targeted treatments.
Addressing a Critical Healthcare Need
The scale of PTSD's impact on military veterans underscores the trial's significance. According to the US National Center for PTSD, the condition affected approximately 13 million Americans in 2020, with a particularly high prevalence among veterans, affecting seven out of every 100 former service members.
"We believe adaptive platform trials offer a powerful way to achieve this goal and make a meaningful impact on patients' lives," stated Meredith Buxton, GCAR's president. "We are honoured 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."
Political Considerations
The trial's implementation occurs against a backdrop of political uncertainty, with potential implications for government-funded research. Recent developments in the political landscape, including discussions about government hiring freezes under new leadership, may impact the trial's progression, though military and veterans affairs positions have seen some exemptions from these restrictions.
