A Study of Psilocybin for Major Depressive Disorder (MDD)
Public ClinicalTrials.gov record NCT03866174. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind Study of Single-Dose Psilocybin for Major Depressive Disorder (MDD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 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. 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.
Study identification
- NCT ID
- NCT03866174
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 347 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 23, 2020 (Actual)
- Primary completion
- Jun 28, 2022 (Actual)
- Completion
- Jun 28, 2022 (Actual)
- Last update posted
- Apr 22, 2026
2020 – 2022
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94121 | — |
| Pacific Neuroscience Institute | Santa Monica | California | 91404 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Segal Trials | Lauderhill | Florida | 33319 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | — |
| Johns Hopkins University | Baltimore | Maryland | 21229 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| New York University School of Medicine | New York | New York | 10016 | — |
| Cedar Clinical Research | Draper | Utah | 84020 | — |
| University of Wisconsin - Madison | Madison | Wisconsin | 53706 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03866174, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 22, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03866174 live on ClinicalTrials.gov.