10/17/2024
Psilocybin for Major Depressive Disorder (MDD) (uAspire)
This Phase III, randomized, double-blind, multicenter trial (n=240) aims to evaluate the efficacy, safety, and tolerability of psilocybin (5-25mg) in adults with Major Depressive Disorder (MDD).
Participants will be randomly assigned to receive a single oral dose of psilocybin 25 mg, psilocybin 5 mg, or an inactive placebo. The trial consists of a double-blind period followed by a 1-year follow-up period.
During the double-blind period, participants will undergo the “Set and Setting” Protocol for psychosocial support, including preparatory meetings and post-dose integration sessions. Outcome measures include changes in depressive symptoms, functional disability, health-related quality of life, and clinical global impression of disease severity.
After the initial period, participants will proceed to a 1-year follow-up period, during which long-term safety data will be collected, and eligible participants may be offered open-label psilocybin 25 mg re-administration under the “Set and Setting” Protocol.
The study is conducted at various locations across the United States including a site in Little Rock, Arkansas at Preferred Research Partners
Usona Institute Announces Launch of uAspire Phase 3 Clinical Trial Investigating Psilocybin for Major Depressive Disorder Madison, WI USA. (March 20th,…