Medical research organisation Usona Institute has commenced a Phase III clinical trial to evaluate the potential of psilocybin as a therapeutic option for adults diagnosed with major depressive disorder (MDD).
This marks a significant advancement in the development of psilocybin for medical use.
Dubbed the uAspire trial, the randomised, double-blind, multicentre study aims to determine the efficacy, safety, and tolerability of psilocybin in treating MDD.
Approximately 240 adults aged 18 years and above who are experiencing a major depressive episode will be enrolled in the trial.
Participants will receive a 25mg dose of psilocybin, administered alongside psychosocial support.
The initial phase of the trial will span six weeks. Following this treatment period, participants will undergo a one-year follow-up to assess the durability of the treatment and its long-term safety.
Usona Institute chief medical officer Dr Mike Davis said: “The initiation of the Phase III uAspire trial marks an important milestone in the clinical development of psilocybin as a potential new treatment for major depressive disorder.
“Following the robust safety and efficacy findings from our Phase II study PSIL201, the uAspire trial is designed to deepen our understanding of psilocybin’s treatment durability and long-term safety.
“To ensure broad applicability of the study findings, we are committed to the inclusion of adults from diverse backgrounds and treatment settings, including top academic institutions, clinical research sites, and VA medical centres across the country.”
In November 2019, the US Food and Drug Administration (FDA) granted breakthrough therapy designation for psilocybin to treat MDD.
The designation comes after the company began a Phase II clinical trial, PSIL201, with 80 participants at seven study centres around the US. In August 2021, Usona Institute commenced the construction of a ‘Global Center in Psychedelic Science’ at Fitchburg, Wisconsin, US.
This facility is intended to offer training and education across academic discovery, clinical research and best practices in developing models for future approved therapies.
