Single Psilocybin Dose 'Significantly' Reduces Major Depression Symptoms, New Usona Phase 2 Trial Shows

Nonprofit medical research organization the Usona Institute shared the results from its Phase 2 trial assessing a single 25mg synthetic psilocybin dose for 104 adults with Major Depressive Disorder (MDD,) providing further evidence of the psychedelic’s antidepressant capabilities.

Led by a research team from institutions including Yale, Johns Hopkins, NYU Langone and San Francisco Veterans Affairs Medical Center and published in the Journal of the American Medical Association (JAMA,) outcomes reveal that psilocybin was well-tolerated and elicited fast, solid and long-lasting efficacy results. 

The reportedly largest Phase 2, randomized, double-blind, placebo-controlled study of a single psilocybin dose to treat MDD followed participants for six weeks and took place between Dec. 2019 and June 2022. 

The 25mg dose paired with psychological support was associated with a significant reduction in depressive symptoms at day 8 post-administration and sustaining those levels across the six-week follow-up period “without attenuation of the effect.” Further, no serious treatment-emergent adverse events occurred, the authors reported.

Usona’s clinical and translational research director Dr. Charles Raison says the data suggests a “truly encouraging” benefit. 

“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,” said Raison. “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 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.”

Usona’s CMO Dr. Mike Davis added that the study’s results provide further support for psilocybin’s potential as “a paradigm-changing treatment” for people suffering from MDD. 

“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,” Davis stated, adding the team is preparing to launch its next study toward providing additional safety and efficacy data to support submission of a new drug application to the FDA.

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Photo: Benzinga edit with photo by Cannabis_Pic and Gorodenkoff and Troyan on Shutterstock.