Depression is the leading cause of disability worldwide, affecting more than 300 million people, according to the World Health Organization. It can reduce life expectancies by an average of 10 years 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.
A series of academic studies have shown that a single high dose of the psilocybin produces a rapid and durable reduction in depression — even in patients who have failed currently approved antidepressants. Like other psychedelics, the pharmacological profile of psilocybin is novel and the nature of its clinical activity represents a new paradigm in the treatment of mental illness.
Usona Institute, a 501(c)3 nonprofit Medical Research Organization based in Madison, Wisconsin, USA, was founded in 2014 for the purpose of moving the highly encouraging early-phase psilocybin studies at UCLA, Johns Hopkins, and New York University, and others through the necessary phases of FDA-regulated clinical trials with the aim of an FDA new drug approval. Usona’s first psilocybin clinical trial will begin in late 2019, and will examine the safety and efficacy of psilocybin for the treatment of major depressive disorder (MDD).
In this presentation, Dr. Charles Raison will discuss the unmet medical need in depression treatment, the results of promising academic studies to date, and Usona’s unique role in sponsoring FDA-regulated clinical trials as a nonprofit medical research entity following an Open Science approach to research and drug development.