Yesterday we received results of the Usona Institute’s Phase 2 trial using psilocybin for depression.

Usona is a non-profit medical research organization, running a variety of trials and research on psychedelic medicine. The institute has been sponsoring this long-running trial, the largest Phase 2, double-blind, placebo-controlled study evaluating a single dose of psilocybin to treat major depressive disorder.

The trial dosed 104 adults between December 2019 and June 2022, across a variety of sites. The results were published in Jama and showed that psilocybin was well-tolerated with solid efficacy results.

Psilocybin treatment (with therapy) was associated with a significantly reduced MADRS depression score compared with placebo: Day 8 (-17.8 vs -5.8) and Day 43 (-19.1 vs -6.8)

“In this phase 2 study, treatment with a 25-mg dose of psilocybin administered with psychological support was associated with a statistically and clinically significant reduction in depressive symptoms compared with a niacin placebo.”

Results from our multi-site study of psilocybin-assisted therapy for MDD are live today in @JAMA_current. Psilocybin had about a 12 point MADRS advantage over niacin control at day 8 that appeared durable through 6 wk follow-up. https://t.co/oUIE9ZhplV 1/ pic.twitter.com/YucAdXhMuO

— Natalie Gukasyan, MD (@N_Gukasyan) August 31, 2023

This study provides another data point for the efficacy of psilocybin in treating depression, and should bolster the case for other similar trials in the space.

See Usona’s press release below.

Usona statement on JAMA publication of PSIL201 data

August 31, 2023. We are pleased to announce that results are now available for Usona Institute’s PSIL201 clinical trial, the largest Phase 2, randomized, double-blind, placebo-controlled study of single-dose psilocybin to treat major depressive disorder.

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Charles Raison, MD, Director of Clinical and Translational Research, Usona Institute:

“The data suggest a benefit which is truly encouraging. As the largest and most rigorous study conducted across a wide spectrum of individuals with major depressive disorder, the results show promise for all people struggling with this condition. It could provide hope for those who have not responded to other treatments, and it could also present a viable option for individuals seeking to avoid long-term treatment with standard antidepressants. We see a signal of benefit suggesting that psilocybin may be a new option to aid people in all stages of their struggle with depression. The PSIL201 data tells its own compelling story and speaks to the fact that a single treatment with psilocybin produces a rapid, large and sustained antidepressant effect.”

“This study could not have been done without the amazing help of researchers at a number of the country’s most prestigious academic and research organizations whose careful work and dedication made PSIL201 a success.”

Listen to Dr. Charles Raison discuss the PSIL201 data in this JAMA Author Interviews podcast published August 31, 2023.

Mike Davis, MD, Chief Medical Officer, Usona Institute:

“We are pleased about the results from PSIL201 which provide further support for psilocybin’s potential as a paradigm-changing treatment for people suffering from major depressive disorder. As a nonprofit medical research organization, Usona is committed to safely and effectively making this new treatment accessible to those in need of better options. We are diligently preparing to launch our next study, which will provide additional safety and efficacy data to support submission of a new drug application to the FDA.”

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Usona Institute is a 501(c)(3) non-profit medical research organization located in Madison, WI dedicated to supporting and conducting basic, pre-clinical and clinical research to further the scientific understanding and therapeutic application of consciousness-expanding medicines. The organization’s focus is the treatment of society’s most challenging mental health conditions for which existing treatments fall short.