Psilocybin for Major Depressive Disorder (MDD)

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

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.

Key facts

Study ID

NCT06308653

Run by

Usona Institute

People needed

238

Starts

2024-03-13

Expected to finish

2027-01-30

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults ≥18 years old.
• Able to swallow capsules.
• If of childbearing potential, agree to practice an effective means of birth control throughout the duration of the study.
• Meet the DSM-5-TR criteria for a diagnosis of major depressive disorder and are currently experiencing a major depressive episode of at least a 60-day duration at the time of Screening.
• Have at least moderate severity of depression symptoms at Screening and Trial Baseline.

You may not qualify if…

• Participants who are pregnant, who intend to become pregnant during the trial, or who are currently nursing.
• Have any of the following cardiovascular conditions: coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, clinically-relevant valvular heart disease, pulmonary hypertension, myocardial infarction, a clinically significant ECG abnormality, or tachycardia.
• Have elevated blood pressure.
• Have neurological conditions such as stroke, including transient ischemic attack, epilepsy, neurodegenerative disease (e.g., dementia, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis, etc.), or brain tumor.
• Have severe hepatic or renal impairment.
• Have uncontrolled diabetes mellitus or unstable existing thyroid disorder.
• Are hepatitis or HIV positive.
• Have a positive urine drug test for illicit, non-prescribed, or prohibited substances.
• Meet DSM-5-TR criteria for schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features ,bipolar disorder (types 1 or 2), antisocial personality disorder, borderline personality disorder or moderate or severe alcohol or drug use disorder
• Meet DSM-5-TR criteria for active post-traumatic stress disorder within 6 months prior to Screening.
• Have a first-degree relative with schizophrenia spectrum or other psychotic disorders, or bipolar I disorder.

Where it is running

• 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

Full record on ClinicalTrials.gov

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