“Nearly one in fifteen people in the US experiences an episode of major depression each year* , significantly lowering their ability to function at work, to enjoy life, and to live out their full life potential. At Usona, our goal is to contribute to well-being by demonstrating the safety and efficacy of psilocybin as a treatment for depression. This goal fuels us to carry out research of the highest standard, with an aim toward FDA approval for a treatment that could change lives.”
— Malynn Utzinger, M.D., Co- Executive Director
Depression is the leading cause of disability worldwide, affecting more than 300 million people, according to the World Health Organization. It can rob people of their joy in life, reduce life expectancies by an average of 10 years by damaging the brain and body, and may lead to suicide from which nearly 800,000 people die each year. There is an urgent need to identify and test novel treatments that may benefit people suffering from depression.
As part of our mission to alleviate mental suffering, Usona is exploring the therapeutic potential of under-examined psychedelic medicines, with a current focus on psilocybin. Usona’s work in this area builds upon the strength and legacy of highly encouraging early-phase studies at UCLA, Johns Hopkins, and New York University, among others. Recognizing the need to move psilocybin research through the necessary phases of clinical trials with the aim of an FDA new drug approval, Usona has elected to take on the role of FDA drug “sponsor.” As a sponsor, Usona is responsible for the initiation, management, and finance of the clinical trials, as well as for the production of cGMP psilocybin that is tested for safety and purity under highly controlled and monitored conditions.
Usona Institute is currently in the planning phases for our multi-site Phase 2/Phase 3 clinical research program focused on psilocybin as a treatment for major depressive disorder (MDD). We are working in close collaboration with our contract research organization, pharmaceutical contract manufacturer, research site personnel, internal and external experts, and regulatory officials to develop our cGMP psilocybin and study protocols with the rigor and safety necessary for late-phase FDA clinical trials.
For more information on depression and our clinical trials, please follow the link below:
To learn more about the history of psilocybin research, please see the video below featuring Charles Raison, MD, Usona’s Director of Clinical and Translational Research.
Investigator’s Brochure for Psilocybin
The Investigator’s Brochure for psilocybin is a detailed compendium of information on psilocybin’s pharmacology, safety, and efficacy. Consistent with our open science approach, this document will be openly shared with other researchers for use in their own regulatory submissions and clinical trials, under a Creative Commons license. To view the document, please see: Usona Investigator’s Brochure for Psilocybin
Cancer-related depression and anxiety
Studies in healthy adults
Chapters & Books
“Use of the Classic Hallucinogen Psilocybin for Treatment of Existential Distress Associated with Cancer.” 2013. Grob CS, Bossis AP, Griffiths RR. In Psychological Aspects of Cancer, (pp. 291–308). Carr BI, Steel JL (Eds). Springer Science and Business Media LLC, New York.
Frontiers of Psychedelic Consciousness: Conversations with Albert Hofmann, Stanislav Grof, Rick Strassman, Jeremy Narby, Simon Posford, and Others. By David Jay Brown, 2015.
Higher Wisdom: Eminent Elders Explore the Continuing Impact of Psychedelics. Edited by Roger Walsh and Charles S. Grob, 2005.
Psychedelic Explorer’s Guide: Safe, Therapeutic and Sacred Journeys. 2011. James Fadiman. Park Street Press.
Sacred Knowledge: Psychedelics and Religious Experiences. By William A. Richards, 2015.
The Psilocybin Solution: The Role of Sacred Mushrooms in the Quest for Meaning. By Simon G. Powell, 2011.
The goal of Usona’s grant program is to advance knowledge about the potential therapeutic effects of psilocybin and other consciousness-expanding medicines, consistent with Usona’s overall mission and goals. Grant requests must be of high scientific caliber, and are evaluated on a rolling basis. For more information, please contact us.