Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
240 participants
INTERVENTIONAL
2024-03-13
2026-12-30
Brief Summary
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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.
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Detailed Description
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Participants who show stable depression symptoms between Screening and Trial Baseline will be randomly assigned to receive a single oral dose of Psilocybin 25 mg, Psilocybin 5 mg, or inactive placebo.
Investigational Product (IP) will be administered in the context of a "Set and Setting" (SaS) Protocol for psychosocial support, comprised of 1) a period of preparation with Facilitators prior to dosing; 2) administration of IP in an aesthetically pleasing room under the supervision of two Facilitators; and 3) post-dose integration sessions during which participants will discuss their dosing experience with the Facilitators.
Trial outcome measures will assess depressive symptoms, functional disability, health-related quality of life, and clinical global impression of disease severity.
Long-term Follow-up Period:
After the initial 6-week Double-blind Period and completion of the post-dosing Trial Day 43 assessments, all participants will proceed into a 1-year Follow-up Period.
During the 1-year Follow-up Period, participants will be followed regularly by clinic staff to assess MDD symptom severity, functional disability, and health-related quality of life; long-term safety data will also be collected. In addition to scheduled clinic visits, clinic staff will contact participants by telephone every two weeks to assess for changes in MDD symptom severity, concomitant medications, adverse events (AEs), and suicidal ideation and behavior.
Participants who meet the pre-defined MDD severity criteria and meet all re-administration eligibility criteria may be offered re-administration(s) of open-label Psilocybin 25 mg administered under a "Set and Setting" (SaS) Protocol. Psychosocial support, including psychoeducation, is also incorporated in the long-term Follow-up Period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
All roles other than the Sponsor, CRO, and Ethics Committees will also be blinded to the randomization ratio and Patient Health Questionnaire-9 (PHQ-9) score for re-administration eligibility.
The Central MADRS Rater will also be blinded to all aspects of the protocol and trial visit for each participant.
Blinded trial site personnel will complete administration of the IP.
Full blinding of trial personnel, Sponsor, and participants will be maintained until database lock at the conclusion of the trial.
Study Groups
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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.
Psilocybin 25 mg
The Psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated within a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of Psilocybin.
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.
Psilocybin 5 mg
The Psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active comparator is encapsulated within a hydroxypropyl methylcellulose (HPMC) capsule and contains 5 mg of Psilocybin.
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.
Inactive Placebo
The inactive placebo is encapsulated within a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of Microcrystalline Cellulose (MCC). The MCC is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use.
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.
Psilocybin 25 mg
The Psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated within a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of Psilocybin.
Psychosocial Support
Psychosocial Support, including psychoeducation, begins after the Double-blind Period and continues throughout the 1-year Follow-up Period in order to enhance participant safety and maximize retention for the entire trial duration.
Interventions
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Psilocybin 25 mg
The Psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated within a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of Psilocybin.
Inactive Placebo
The inactive placebo is encapsulated within a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of Microcrystalline Cellulose (MCC). The MCC is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use.
Psilocybin 5 mg
The Psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active comparator is encapsulated within a hydroxypropyl methylcellulose (HPMC) capsule and contains 5 mg of Psilocybin.
Psychosocial Support
Psychosocial Support, including psychoeducation, begins after the Double-blind Period and continues throughout the 1-year Follow-up Period in order to enhance participant safety and maximize retention for the entire trial duration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Usona Institute
OTHER
Responsible Party
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Locations
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University of Alabama Clinical Research Unit
Birmingham, Alabama, United States
Preferred Research Partners-NWA, LLC
Fayetteville, Arkansas, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Kadima Neuropsychiatry Institute
La Jolla, California, United States
West LA VA Medical Center - Mental Health Department
Los Angeles, California, United States
Pacific Neuroscience Institute (PNI) at Saint John's Physician Partners
Santa Monica, California, United States
Psychedelic Science Institute
Santa Monica, California, United States
Mountain View Clinical Research
Denver, Colorado, United States
Connecticut Mental Health Center, Yale University
New Haven, Connecticut, United States
Clinical Neuroscience Solutions Inc.
Jacksonville, Florida, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Johns Hopkins School of Medicine, Center for Psychedelic and Consciousness Research
Baltimore, Maryland, United States
Sunstone Medical PC
Rockville, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
VA Nebraska Western Iowa Health Care System
Omaha, Nebraska, United States
Global Medical Institutes, LLC; Princeton Medical Institute
Princeton, New Jersey, United States
University of New Mexico (UNM) Interdisciplinary Substance Use and Brain Injury (ISUBI) Center
Albuquerque, New Mexico, United States
NYU Clinical & Translational Science Institute
New York, New York, United States
Bronx Veterans Research Foundation at the James J. Peters VAMC
The Bronx, New York, United States
AIM Trials, LLC
Plano, Texas, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
Cedar Clinical Research
Draper, Utah, United States
Cedar Clinical Research, Inc.
Murray, Utah, United States
Seattle Neuropsychiatric Treatment Center
Bellevue, Washington, United States
VA Portland Health Care System
Vancouver, Washington, United States
Countries
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References
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Raison CL, Sanacora G, Woolley J, Heinzerling K, Dunlop BW, Brown RT, Kakar R, Hassman M, Trivedi RP, Robison R, Gukasyan N, Nayak SM, Hu X, O'Donnell KC, Kelmendi B, Sloshower J, Penn AD, Bradley E, Kelly DF, Mletzko T, Nicholas CR, Hutson PR, Tarpley G, Utzinger M, Lenoch K, Warchol K, Gapasin T, Davis MC, Nelson-Douthit C, Wilson S, Brown C, Linton W, Ross S, Griffiths RR. Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial. JAMA. 2023 Sep 5;330(9):843-853. doi: 10.1001/jama.2023.14530.
Palitsky R, Maples-Keller JL, Peacock C, Dunlop BW, Mletzko T, Grant GH, Raison CL, Chao S, Shub I, Mendelbaum-Kweller M, Smolyar L, Kaplan DM, Rothbaum BO, Zarrabi AJ. A critical evaluation of psilocybin-assisted therapy protocol components from clinical trial patients, facilitators, and caregivers. Psychotherapy (Chic). 2025 Sep;62(3):348-362. doi: 10.1037/pst0000551. Epub 2025 Jan 13.
Other Identifiers
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PSIL301
Identifier Type: -
Identifier Source: org_study_id
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