The US Military’s Defence Health Agency (DHA) has partnered with the Global Coalition for Adaptive Research (GCAR) for a platform trial seeking therapies for post-traumatic stress disorder (PTSD) in active soldiers and veterans.
The Military and Veterans PTSD Adaptive Platform Clinical Trial (M-PACT) (NCT05422612) is a Phase II randomised, double-blinded, placebo-controlled study that is set to evaluate multiple potential pharmacotherapeutic interventions for PTSD over a 12-week treatment period.
The trial is split into three interventions, A, B & C, as well as parallel placebo groups. Cohort A will see volunteers dosed with 10mg to 60mg of Prozac. The B arm will be treated with Merck’s Viibryd, known generically as vilazodone. Arm C will be treated, once daily with 50mg of Idorsia’s insomnia drug Quviviq (daridorexant).
Primary endpoints for the trial are set to measure the change in PTSD symptom severity from baseline as measured by the Clinician-Administered PTSD Scale-5-Revised system, which comes in the form of a scale between one to 200. The trial’s other primary measure will additionally examine the incidence of new or worsening suicidal thoughts or behaviours as measured by change in the Columbia Suicide Severity Rating Scale.
The trial will also gather data on biological indicators to determine whether military personnel and veterans with PTSD have any shared biological characteristics to reveal targets for future drug development.
Presently the US National Center for PTSD estimates that there are approximately 13 million Americans had some form of PTSD in 2020, with the condition affecting seven out of every 100 military veterans.
Meredith Buxton, president of the non-profit at GCAR, said: “We believe adaptive platform trials offer a powerful way to achieve this goal and make a meaningful impact on patients’ lives. 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."
It remains to be seen whether trials funded and assisted by US healthcare and military bodies may be paused or halted after new President Donald Trump called for a complete freeze on government hiring . Whilst some military and veterans […]
US’ DHA launches platform trial to tackle PTSD in soldiers and veterans
