A Study of Psilocybin for Major Depressive Disorder (MDD)
Status:
Recruiting
Trial end date:
2022-05-30
Target enrollment:
Participant gender:
Summary
One hundred participants, ages 21 to 65, who meet Diagnostic and Statistical Manual of Mental
Disorders (DSM-5) criteria for major depressive disorder (MDD) will be stratified by study
site and randomized with a 1-to-1 allocation under double-blind conditions to receive a
single 25 mg oral dose of psilocybin or a single 100 mg oral dose of niacin. Niacin will
serve as an active placebo.
The purpose of this study is to evaluate the potential efficacy of a single 25 mg oral dose
of psilocybin for MDD compared to the active placebo in otherwise medically-healthy
participants, assessed as the difference between groups in changes in depressive symptoms
from Baseline to Day 43 post-dose.
Phase:
Phase 2
Details
Lead Sponsor:
Usona Institute
Collaborators:
Bracket Global Signant Health The Emmes Company, LLC The EMMES Corporation