Using Psilocybin to Treat Major Depressive Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy, safety, and tolerability of a single oral dose of Psilocybin (25 mg) compared to lower doses and a placebo in adults diagnosed with Major Depressive Disorder (MDD). Approximately 240 participants will be randomly assigned to receive either the active drug or placebo, with their depressive symptoms assessed over a 43-day period following the dose. The study includes a structured psychosocial support framework to enhance the treatment experience, and participants will be monitored for a year to evaluate long-term effects and safety. Outcome measures will focus on changes in depressive symptoms, functional disability, and overall quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• University of Alabama Clinical Research Unit
  Birmingham, Alabama, United States Recruiting
• Preferred Research Partners-NWA, LLC
  Fayetteville, Arkansas, United States Recruiting
• Preferred Research Partners, Inc.
  Little Rock, Arkansas, United States Recruiting
• Kadima Neuropsychiatry Institute
  La Jolla, California, United States Recruiting
• West LA VA Medical Center - Mental Health Department
  Los Angeles, California, United States Recruiting
• Pacific Neuroscience Institute (PNI) at Saint John's Physician Partners
  Santa Monica, California, United States Recruiting

Study contacts

• Study coordinator: Kasia Warchol
• Email: ClinicalTrials@usonainstitute.org
• Phone: 608-210-6016

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.