Psilocybin for Major Depressive Disorder (MDD) (NCT06308653)
A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults With Major Depressive Disorder (MDD)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama Clinical Research Unit — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (29 Sites)
Showing the first 25 of 29 sites.
- University of Alabama Clinical Research Unit — Birmingham, Alabama
- Preferred Research Partners-NWA, LLC — Fayetteville, Arkansas
- Preferred Research Partners, Inc. — Little Rock, Arkansas
- Kadima Neuropsychiatry Institute — La Jolla, California
- West LA VA Medical Center - Mental Health Department — Los Angeles, California
- Pacific Neuroscience Institute (PNI) at Saint John's Physician Partners — Santa Monica, California
- Psychedelic Science Institute — Santa Monica, California
- Mountain View Clinical Research — Denver, Colorado
- Connecticut Mental Health Center, Yale University — New Haven, Connecticut
- Clinical Neuroscience Solutions Inc. — Jacksonville, Florida
- Innovative Clinical Research, Inc. — Lauderhill, Florida
- Clinical Neuroscience Solutions, Inc. — Orlando, Florida
- Emory University — Atlanta, Georgia
- CenExel iResearch, LLC — Decatur, Georgia
- Great Lakes Clinical Trials — Chicago, Illinois
- Johns Hopkins School of Medicine, Center for Psychedelic and Consciousness Research — Baltimore, Maryland
- Sunstone Medical PC — Rockville, Maryland
- Washington University School of Medicine — St Louis, Missouri
- VA Nebraska Western Iowa Health Care System — Omaha, Nebraska
- Global Medical Institutes, LLC; Princeton Medical Institute — Princeton, New Jersey
- University of New Mexico (UNM) Interdisciplinary Substance Use and Brain Injury (ISUBI) Center — Albuquerque, New Mexico
- NYU Clinical & Translational Science Institute — New York, New York
- Bronx Veterans Research Foundation at the James J. Peters VAMC — The Bronx, New York
- AIM Trials, LLC — Plano, Texas
- Clinical Trials of Texas, LLC — San Antonio, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms — Birmingham, Alabama
Explore by condition: All Depressive Disorder, Major clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.