Compass Pathways Collaborates With U.S. Department Of Veterans Affairs On A Multi-Site Randomized Controlled Clinical Trial

The study will evaluate the safety and efficacy of COMP360 psilocybin in the treatment of treatment-resistant depression (TRD) in veterans, including those with concurrent post-traumatic stress disorder (PTSD).

The trial, titled "Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression," or PIVOT, reflects VA’s commitment to pursuing innovative solutions for veterans who have not responded to existing treatments.

Compass will donate the study drug - COMP360, a synthetic, proprietary pharmaceutical-grade formulation of psilocybin optimized for stability and purity.

Compass will support the education and training of the investigators and their training team through the provision of training materials, guidance, and consultation on administration protocols.

In turn, the investigators and their training team will train the initial cohort of health care providers and will be prepared to train additional support providers as needed.

The multi-site, double-blind, randomized controlled trial will enroll veterans diagnosed with TRD, with or without concurrent PTSD, and will compare outcomes between two different doses of COMP360 psilocybin with the option for a second open label administration four weeks after initial dose.

The primary measure of efficacy will be depression severity, assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS).

Secondary outcomes will include assessments of PTSD symptom severity, tolerability of side effects, and overall patient-reported depression.

The lead site is the Birmingham VA Health Care System in Alabama, in collaboration with four additional VA sites in Tuscaloosa, Portland, Seattle and Philadelphia. "TRD is a critical and complex mental health challenge among veterans, often occurring alongside PTSD and underscoring the urgent need for innovative, evidence-based solutions," said Kabir Nath, Chief Executive Officer of Compass Pathways. "We are honored to be selected as the partner of choice for this groundbreaking study and look forward to supporting Dr.

Davis and the broader research team throughout its course.

We’re deeply grateful for the resources provided by the VA to explore the potential of COMP360 psilocybin in addressing TRD among veterans - an effort that holds promise for transforming care and restoring hope." "Veterans living with TRD face immense challenges that demand more effective, transformative treatments to support their recovery and reintegration into civilian life," said Dr.

Lori Davis, Principal Investigator of the study at Birmingham VA Healthcare System. "We’re pleased to partner with Compass Pathways on this pioneering investigation, exploring psilocybin’s potential to treat not only TRD, but also comorbid PTSD—an area that remains largely unexplored.

Psilocybin has the potential to mark a major breakthrough in mental health care for veterans, offering renewed hope, and improving overall quality of life for those who have exhausted available options."