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Psilocybin for Major Depressive Disorder (MDD)
Sponsor: Usona Institute
Summary
Approximately 240 eligible adult participants (≥18 years old) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for Major Depressive Disorder (MDD) will be enrolled. Participants will be randomly assigned to receive a single oral dose of Psilocybin 25 mg, Psilocybin 5 mg, or inactive placebo. The purpose of this study is to evaluate the efficacy, safety, and tolerability of Psilocybin 25 mg versus placebo in adults with MDD, as assessed by the difference between groups in change in depressive symptoms from Baseline to Day 43 post-dose, and to characterize the durability of initial treatment effect and subsequent response to optional Psilocybin 25 mg re-administration(s) during the 1-year Follow-up Period.
Official title: A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults With Major Depressive Disorder (MDD)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2024-03-13
Completion Date
2026-12-30
Last Updated
2025-12-15
Healthy Volunteers
No
Conditions
Interventions
Psilocybin 25 mg
The Psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated within a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of Psilocybin.
Inactive Placebo
The inactive placebo is encapsulated within a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of Microcrystalline Cellulose (MCC). The MCC is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use.
Psilocybin 5 mg
The Psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active comparator is encapsulated within a hydroxypropyl methylcellulose (HPMC) capsule and contains 5 mg of Psilocybin.
Psychosocial Support
Psychosocial Support, including psychoeducation, begins after the Double-blind Period and continues throughout the 1-year Follow-up Period in order to enhance participant safety and maximize retention for the entire trial duration.
Locations (29)
University of Alabama Clinical Research Unit
Birmingham, Alabama, United States
Preferred Research Partners-NWA, LLC
Fayetteville, Arkansas, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Kadima Neuropsychiatry Institute
La Jolla, California, United States
West LA VA Medical Center - Mental Health Department
Los Angeles, California, United States
Pacific Neuroscience Institute (PNI) at Saint John's Physician Partners
Santa Monica, California, United States
Psychedelic Science Institute
Santa Monica, California, United States
Mountain View Clinical Research
Denver, Colorado, United States
Connecticut Mental Health Center, Yale University
New Haven, Connecticut, United States
Clinical Neuroscience Solutions Inc.
Jacksonville, Florida, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Johns Hopkins School of Medicine, Center for Psychedelic and Consciousness Research
Baltimore, Maryland, United States
Sunstone Medical PC
Rockville, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
VA Nebraska Western Iowa Health Care System
Omaha, Nebraska, United States
Global Medical Institutes, LLC; Princeton Medical Institute
Princeton, New Jersey, United States
University of New Mexico (UNM) Interdisciplinary Substance Use and Brain Injury (ISUBI) Center
Albuquerque, New Mexico, United States
NYU Clinical & Translational Science Institute
New York, New York, United States
Bronx Veterans Research Foundation at the James J. Peters VAMC
The Bronx, New York, United States
AIM Trials, LLC
Plano, Texas, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
Cedar Clinical Research
Draper, Utah, United States
Cedar Clinical Research, Inc.
Murray, Utah, United States
Seattle Neuropsychiatric Treatment Center
Bellevue, Washington, United States
VA Portland Health Care System
Vancouver, Washington, United States