A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults With Major Depressive Disorder (MDD)
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
University of Alabama Clinical Research Unit
RECRUITING
Birmingham
Arkansas
Preferred Research Partners-NWA, LLC
TERMINATED
Fayetteville
Preferred Research Partners, Inc.
RECRUITING
Little Rock
California
Kadima Neuropsychiatry Institute
RECRUITING
La Jolla
West LA VA Medical Center - Mental Health Department
RECRUITING
Los Angeles
Pacific Neuroscience Institute (PNI) at Saint John's Physician Partners
TERMINATED
Santa Monica
Psychedelic Science Institute
RECRUITING
Santa Monica
Colorado
Mountain View Clinical Research
RECRUITING
Denver
Connecticut
Connecticut Mental Health Center, Yale University
RECRUITING
New Haven
Florida
Clinical Neuroscience Solutions Inc.
RECRUITING
Jacksonville
Innovative Clinical Research, Inc.
RECRUITING
Lauderhill
Clinical Neuroscience Solutions, Inc.
RECRUITING
Orlando
Georgia
Emory University
RECRUITING
Atlanta
CenExel iResearch, LLC
RECRUITING
Decatur
Illinois
Great Lakes Clinical Trials
RECRUITING
Chicago
Maryland
Johns Hopkins School of Medicine, Center for Psychedelic and Consciousness Research
RECRUITING
Baltimore
Sunstone Medical PC
ACTIVE_NOT_RECRUITING
Rockville
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Nebraska
VA Nebraska Western Iowa Health Care System
RECRUITING
Omaha
New Jersey
Global Medical Institutes, LLC; Princeton Medical Institute
RECRUITING
Princeton
New Mexico
University of New Mexico (UNM) Interdisciplinary Substance Use and Brain Injury (ISUBI) Center
RECRUITING
Albuquerque
New York
NYU Clinical & Translational Science Institute
RECRUITING
New York
Bronx Veterans Research Foundation at the James J. Peters VAMC
RECRUITING
The Bronx
Pennsylvania
Scranton Medical Institute, LLC
WITHDRAWN
Moosic
Texas
AIM Trials, LLC
RECRUITING
Plano
Clinical Trials of Texas, LLC
RECRUITING
San Antonio
Utah
Cedar Clinical Research
ACTIVE_NOT_RECRUITING
Draper
Cedar Clinical Research, Inc.
RECRUITING
Murray
Washington
Seattle Neuropsychiatric Treatment Center
RECRUITING
Bellevue
VA Portland Health Care System
RECRUITING
Vancouver
Contact Information
Primary
Anny Ortiz, PhD
ClinicalTrials@usonainstitute.org
608-210-6016
Time Frame
Start Date: 2024-03-13
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 240
Treatments
Experimental: Psilocybin 25 mg
During the Double-blind Period, participants randomized to receive Psilocybin 25 mg will receive a single dose administered orally as a capsule and taken with water, along with the Set and Setting (SaS) Protocol.~The Set and Setting (SaS) Protocol includes preparatory meetings with two Facilitators prior to dosing, a 7-10 hour dosing session in a comfortable room under the supervision of the same two Facilitators, and 4 hours of post-dose integration sessions with Facilitators. During the dosing session, participants are encouraged to wear eyeshades and listen to a curated playlist on headphones.
Active_comparator: Psilocybin 5 mg
During the Double-blind Period, participants randomized to receive Psilocybin 5 mg will receive a single dose administered orally as a capsule and taken with water, along with the Set and Setting (SaS) Protocol.~The Set and Setting (SaS) Protocol includes preparatory meetings with two Facilitators prior to dosing, a 7-10 hour dosing session in a comfortable room under the supervision of the same two Facilitators, and 4 hours of post-dose integration sessions with Facilitators. During the dosing session, participants are encouraged to wear eyeshades and listen to a curated playlist on headphones.
Placebo_comparator: Inactive Placebo
During the Double-blind Period, participants randomized to receive inactive placebo will receive a single dose of Microcrystalline Cellulose (MCC) 25 mg administered orally as a capsule and taken with water, along with the Set and Setting (SaS) Protocol.~The Set and Setting (SaS) Protocol includes preparatory meetings with two Facilitators prior to dosing, a 7-10 hour dosing session in a comfortable room under the supervision of the same two Facilitators, and 4 hours of post-dose integration sessions with Facilitators. During the dosing session, participants are encouraged to wear eyeshades and listen to a curated playlist on headphones.
Other: Long-Term Follow-Up
After the initial 6-week Double-blind Period, all participants will proceed to a 1-year Follow-up Period. Participants will be followed via in-clinic visits and telephone visits during which clinic staff will assess changes in MDD symptom severity and safety measures including concomitant medications, adverse events (AEs), and suicidal ideation and behavior.~Participants will also engage in group psychosocial support sessions, including psychoeducation, throughout this period.~Participants may also be eligible to receive open-label re-administration(s) of Psilocybin 25 mg under the Set and Setting (SaS) Protocol if re-administration eligibility criteria are met.
Related Therapeutic Areas
Sponsors
Leads: Usona Institute