Status:
COMPLETED
A Study of Psilocybin for Major Depressive Disorder (MDD)
Lead Sponsor:
Usona Institute
Collaborating Sponsors:
The Emmes Company, LLC
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief 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 random...
Detailed Description
Major depressive disorder (MDD) has become a health crisis of epidemic proportions in the modern world. One in six individuals in the United States will experience an episode of major depression in hi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2022
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT03866174
Start Date
October 15 2019
End Date
June 28 2022
Last Update
June 5 2023
Active Locations (11)
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1
University of California, San Francisco
San Francisco, California, United States, 94121
2
Pacific Neuroscience Institute
Santa Monica, California, United States, 91404
3
Yale University
New Haven, Connecticut, United States, 06520
4
Segal Trials
Lauderhill, Florida, United States, 33319