MADISON, Wis.--(BUSINESS WIRE)--Usona Institute launches its Phase 2 study of psilocybin for major depressive disorder this fall. The study, PSIL201, will be conducted at seven U.S. sites and will investigate the safety and efficacy of psilocybin for major depressive disorder (MDD). The open dates for the trial will vary by site, with the first sites scheduled to begin enrolling participants within the next two months.
“Our academic colleagues have shown us the potential benefit psilocybin can have on depression in individuals,” says Charles Raison MD, Usona’s Director of Clinical and Translational Research. “We are honored to be able to take this work to the next level, advancing this new option in the care of people suffering from major depressive disorder. It’s a significant milestone and a glimmer of hope in this field where limited progress has been made in over 30 years.” The World Health Organization cites depression as the number one cause of disability worldwide.
The Usona Institute study will use a randomized, double-blind, placebo-controlled design to evaluate the potential antidepressant effects of a single dose of psilocybin in 80 patients with MDD. Clinical sites are in the final stages of preparing their teams and completing study-specific training related to the trial protocol.
Sites and principal investigators participating in the study include: Johns Hopkins University (Roland Griffiths, PhD), NYU School of Medicine (Stephen Ross, MD), University of California San Francisco (Joshua Woolley, MD, PhD), Yale University (Gerard Sanacora, MD, PhD), University of Wisconsin-Madison (Randall Brown, MD), Great Lakes Clinical Trials (Rupal Trivedi, MD) in Chicago, and Segal Trials (Rishi Kakar, MD) in Miami.
For inquiries and status on this study, visit www.usonaclinicaltrials.org.
Usona Institute is conducting its research on an Open Science platform to accelerate scientific learning in this 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.
The launch will be announced at the INSIGHT conference in Berlin this week. Usona joins international experts at this conference on the scientific findings and therapeutic potential of psychedelics.
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.