Clinical TrialMajor Depressive Disorder (MDD)PsilocybinPlaceboCompleted

A Study of Psilocybin for Major Depressive Disorder (MDD)

Double-blind, randomised, parallel-group Phase II study (n=104 actual) comparing a single 25 mg oral dose of psilocybin to a single 100 mg oral dose of niacin (active placebo) in participants with MDD, assessed to Day 43 post-dose.

Target Enrollment
104 participants
Study Type
Phase II interventional
Design
Randomized, triple Blind

Detailed Description

Randomised, triple-masked, parallel-group trial enrolling adults 21–65 with DSM-5 major depressive disorder to compare a single 25 mg oral dose of synthetic psilocybin versus 100 mg oral niacin (active placebo). Participants receive identical Set and Setting (SaS) procedures.

The SaS protocol includes preparatory meetings with facilitators, an extended supervised dosing session (typically several hours), and post-dose integration sessions. Primary outcome is change in depressive symptoms from baseline to Day 43; safety and tolerability are also assessed.

Study Protocol

Preparation

sessions
420 min each

Dosing

1 sessions
480 min each

Integration

3 sessions
240 min each

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin

experimental

Single 25 mg oral psilocybin with Set and Setting (SaS) protocol.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Encapsulated synthetic psilocybin; administered with SaS protocol.

Niacin

active comparator

Single 100 mg oral niacin (active placebo) with Set and Setting (SaS) protocol.

Interventions

  • Placebo100 mg
    via Oral• single dose• 1 doses total

    Active placebo (niacin) 100 mg; encapsulated.

Participants

Ages
21 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:\n\n* 21 to 65 years old\n* Able to swallow capsules\n* If of childbearing potential, agree to practice an effective means of birth control throughout the duration of the study\n* Have an identified support person and agree to be accompanied home by that person following dosing\n* Have sustained moderate-severe depression symptoms at Screening and Baseline\n* 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

Exclusion Criteria

  • Exclusion Criteria:\n\n* Women who are pregnant or who intend to become pregnant during the study or who are currently nursing\n* 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\n* Have a history of stroke or Transient Ischemic Attack (TIA)\n* Have moderate to severe hepatic impairment\n* Have epilepsy\n* Have insulin-dependent diabetes\n* Have a positive urine drug test\n* Nicotine dependence that would disallow an individual to be nicotine free for the 7-10 hours during the dosing period\n* 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\n* Meet DSM-5 criteria for antisocial personality disorder\n* Meet DSM-5 criteria for a moderate or severe alcohol or drug use disorder

Study Details

Locations

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

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