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

You may be eligible if:     

· You are at least 18 years old

· You have been diagnosed with major depressive disorder

· You have been experiencing a major depressive episode for at least 60 days

· You are willing to stop taking medication for your condition until the end of the study and not start new types of therapy during the study