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MADISON, Wis.

Usona Institute activated its first clinical trial site within NYU School of Medicine, on October 15, 2019 for a Phase 2 clinical trial (PSIL201) investigating the safety and efficacy of psilocybin for major depressive disorder (MDD). Upon completion of study-specific training and meeting regulatory requirements, this first site has been activated and is now actively recruiting participants.

The research conducted at NYU School of Medicine will be led by Principal Investigator Stephen Ross, MD. The Usona study will use a randomized, double-blinded, placebo-controlled design to evaluate the potential antidepressant effects of a single dose of psilocybin in patients with MDD. Other clinical sites are in the final stages of preparing and completing study-specific training related to the protocol. The other sites include: Johns Hopkins University, University of California – San Francisco, Yale University, University of Wisconsin – Madison, Great Lakes Clinical Trials in Chicago, and Segal Trials in Miami.

“This is an exciting time for all of us as we apply the greatest level of clinical rigor to this very important question. With this study underway, we are now one step closer to discovering the degree to which a single treatment with psilocybin will show a clinically-important therapeutic effect in patients with major depressive disorder,” says Charles Raison, MD, Usona’s Director of Clinical and Translational Research.

For more information on this study, please visit www.usonaclinicaltrials.org.

Usona is conducting this research on an Open Science platform to accelerate scientific learning in the field. Usona—along with an array of research organizations, scientists, practitioners, and philanthropists—has signed a statement to make public the scientific discoveries and processes that arise from its research.

Usona Institute is a 501(c)(3) nonprofit medical research organization (MRO) that conducts and supports pre-clinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines. Its focus is on alleviating depression and anxiety in people for whom current medical treatments fall short in offering relief and a better quality of life.

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