A Study of Psilocybin for Major Depressive Disorder (MDD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

One hundred 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 43 post-dose.

Key facts

Study ID

NCT03866174

Run by

Usona Institute

People needed

347

Starts

2020-01-23

Expected to finish

2022-06-28

Last updated by the study team

2026-04-22

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 21 to 65 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
• Have an identified support person and agree to be accompanied home by that person following dosing
• Have sustained moderate-severe depression symptoms at Screening and Baseline
• Meet DSM-5 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

You may not qualify if…

• Women who are pregnant or who intend to become pregnant during the study or who are currently nursing
• Have any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, tachycardia, artificial heart valve, a clinically significant screening ECG abnormality, or any other significant cardiovascular condition
• Have a history of stroke or Transient Ischemic Attack (TIA)
• Have moderate to severe hepatic impairment
• Have epilepsy
• Have insulin-dependent diabetes
• Have a positive urine drug test
• Nicotine dependence that would disallow an individual to be nicotine free for the 7-10 hours during the dosing period
• Meet DSM-5 criteria for schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features, or Bipolar I or Bipolar II Disorder
• Meet DSM-5 criteria for antisocial personality disorder
• Meet DSM-5 criteria for a moderate or severe alcohol or drug use disorder

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Pacific Neuroscience Institute — Santa Monica, California, United States
• Yale University — New Haven, Connecticut, United States
• Segal Trials — Lauderhill, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Great Lakes Clinical Trials — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Hassman Research Institute — Berlin, New Jersey, United States
• New York University School of Medicine — New York, New York, United States
• Cedar Clinical Research — Draper, Utah, United States
• University of Wisconsin - Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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