A Study of Psilocybin for Major Depressive Disorder (MDD)

• Status: Recruiting
• Trial end date: 2022-05-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Usona Institute
• Collaborators: Bracket Global; Signant Health; The Emmes Company, LLC; The EMMES Corporation
• Treatments: Niacin; Niacinamide; Nicotinic Acids; Psilocybin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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