A Study of Psilocybin for Major Depressive Disorder (MDD)
NCT ID: NCT03866174
Last Updated: 2023-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
104 participants
INTERVENTIONAL
2019-10-15
2022-06-28
Brief Summary
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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.
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Detailed Description
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Data suggest that psilocybin may have behavioral effects relevant to the treatment of depression and recent studies also suggest that psilocybin may possess antidepressant properties. To further assess the effects of psilocybin on MDD signs and symptoms, this trial will enroll 100 participants, ages 21 to 65, who meet criteria for MDD. Participants 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.
To enhance participant safety, a Set and Setting (SaS) protocol will be utilized similar to the protocol that has been used in all modern studies of psilocybin. The SaS protocol for this study includes: 1) a period of preparation with session Facilitators prior to dosing; 2) administration of study medications in an aesthetically pleasing room under the supervision of two Facilitators who are present throughout the session; and 3) three post-dose integration sessions during which participants are encouraged to discuss their intervention experience with the Facilitators. The SaS protocol will be identical for those randomized to psilocybin or active placebo.
The primary objective 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 (niacin), assessed as the difference between groups in changes in depressive symptoms from Baseline to Day 43 post-dose.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Psilocybin
Participants will receive a single 25 mg dose of psilocybin along with the Set and Setting (SaS) protocol. Psilocybin is administered orally as a capsule and taken with water.
Psilocybin
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 using a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of psilocybin.
Set and Setting (SaS) Protocol
The SaS Protocol prescribes 6-8 hours of 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.
Niacin
Participants will receive a single 100 mg dose of niacin along with the Set and Setting (SaS) protocol. Niacin is administered orally as a capsule and taken with water.
Niacin
The active placebo is encapsulated using a HPMC capsule and contains 100 mg of pharmaceutical grade niacin.
Set and Setting (SaS) Protocol
The SaS Protocol prescribes 6-8 hours of 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.
Interventions
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Psilocybin
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 using a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of psilocybin.
Niacin
The active placebo is encapsulated using a HPMC capsule and contains 100 mg of pharmaceutical grade niacin.
Set and Setting (SaS) Protocol
The SaS Protocol prescribes 6-8 hours of 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 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
* 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
* 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
21 Years
65 Years
ALL
Yes
Sponsors
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The Emmes Company, LLC
INDUSTRY
Usona Institute
OTHER
Responsible Party
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Locations
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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
Countries
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References
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Related Links
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World Health Organization Overview of Depression
Other Identifiers
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PSIL201
Identifier Type: -
Identifier Source: org_study_id
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