A Study of Psilocybin for Major Depressive Disorder (MDD)
Mental Health & Behavioral Research
What is the purpose of this trial?
Eighty 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 8 post-dose.
- Ages21 years - 65 years
- Trial withUsona Institute
- Start Date11/03/2019
- End Date02/27/2021
- Last Updated03/18/2020
- Study HIC#2000025986