Psilocybin for Major Depressive Disorder (MDD)

Description

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.

Conditions

Depressive Disorder, Major

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Study Overview

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Study Details

Study overview

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.

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults with Major Depressive Disorder (MDD)

Psilocybin for Major Depressive Disorder (MDD)

Condition
Depressive Disorder, Major
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Clinical Research Unit, Birmingham, Alabama, United States, 35209

Fayetteville

Preferred Research Partners-NWA, LLC, Fayetteville, Arkansas, United States, 72703

Little Rock

Preferred Research Partners, Inc., Little Rock, Arkansas, United States, 72211

La Jolla

Kadima Neuropsychiatry Institute, La Jolla, California, United States, 92037

Santa Monica

Pacific Neuroscience Institute (PNI) at Saint John's Physician Partners, Santa Monica, California, United States, 90404

Denver

Mountain View Clinical Research, Denver, Colorado, United States, 80209

New Haven

Connecticut Mental Health Center, Yale University, New Haven, Connecticut, United States, 06519

Jacksonville

Clinical Neuroscience Solutions Inc., Jacksonville, Florida, United States, 32256

Lauderhill

Innovative Clinical Research, Inc., Lauderhill, Florida, United States, 33319

Orlando

Clinical Neuroscience Solutions, Inc., Orlando, Florida, United States, 32801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Usona Institute,

Study Record Dates

2026-04