A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults with Major Depressive Disorder (MDD) (uAspire)

The purpose of this clinical research study is to determine the safety and effectiveness of a treatment with psilocybin in adults diagnosed with major depressive disorder (MDD). Currently available treatments for depression may not work for everyone, so alternative treatments are being sought through clinical research studies. The uAspire study is testing a single oral dose of an investigational drug (psilocybin) for the treatment of MDD. We will look at the investigational drug to learn how well it relieves the symptoms of a major depressive episode compared to treatment versus a placebo group. Participants will also receive psychosocial support—sessions that address a person's emotional, social, mental and spiritual needs—throughout the study from trained study facilitators.

Please see full study details and participation criteria here: https://clinicaltrials.gov/study/NCT06308653