Psilocybin for Major Depressive Disorder (MDD)
Public ClinicalTrials.gov record NCT06308653. 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 Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults With Major Depressive Disorder (MDD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06308653
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 238 participants
Conditions and interventions
Conditions
Interventions
- Psilocybin 25 mg Drug
- Inactive Placebo Drug
- Psilocybin 5 mg Drug
- Psychosocial Support Behavioral
Drug · Behavioral
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Mar 13, 2024 (Actual)
- Primary completion
- Jan 5, 2026 (Actual)
- Completion
- Jan 30, 2027 (Estimated)
- Last update posted
- Oct 21, 2026
2024 – 2027
United States locations
- U.S. sites
- 29
- U.S. states
- 17
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Clinical Research Unit | Birmingham | Alabama | 35209 | — |
| Preferred Research Partners-NWA, LLC | Fayetteville | Arkansas | 72703 | — |
| Preferred Research Partners, Inc. | Little Rock | Arkansas | 72211 | — |
| Kadima Neuropsychiatry Institute | La Jolla | California | 92037 | — |
| West LA VA Medical Center - Mental Health Department | Los Angeles | California | 90073 | — |
| Pacific Neuroscience Institute (PNI) at Saint John's Physician Partners | Santa Monica | California | 90404 | — |
| Psychedelic Science Institute | Santa Monica | California | 90404 | — |
| Mountain View Clinical Research | Denver | Colorado | 80209 | — |
| Connecticut Mental Health Center, Yale University | New Haven | Connecticut | 06519 | — |
| Clinical Neuroscience Solutions Inc. | Jacksonville | Florida | 32256 | — |
| Innovative Clinical Research, Inc. | Lauderhill | Florida | 33319 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | — |
| Emory University | Atlanta | Georgia | 30329 | — |
| CenExel iResearch, LLC | Decatur | Georgia | 30030 | — |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | — |
| Johns Hopkins School of Medicine, Center for Psychedelic and Consciousness Research | Baltimore | Maryland | 21224 | — |
| Sunstone Medical PC | Rockville | Maryland | 20850 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| VA Nebraska Western Iowa Health Care System | Omaha | Nebraska | 68105 | — |
| Global Medical Institutes, LLC; Princeton Medical Institute | Princeton | New Jersey | 08540 | — |
| University of New Mexico (UNM) Interdisciplinary Substance Use and Brain Injury (ISUBI) Center | Albuquerque | New Mexico | 87106 | — |
| NYU Clinical & Translational Science Institute | New York | New York | 10016 | — |
| Bronx Veterans Research Foundation at the James J. Peters VAMC | The Bronx | New York | 10468 | — |
| AIM Trials, LLC | Plano | Texas | 75093 | — |
| Clinical Trials of Texas, LLC | San Antonio | Texas | 78229 | — |
| Cedar Clinical Research | Draper | Utah | 84020 | — |
| Cedar Clinical Research, Inc. | Murray | Utah | 84107 | — |
| Seattle Neuropsychiatric Treatment Center | Bellevue | Washington | 98004 | — |
| VA Portland Health Care System | Vancouver | Washington | 98661 | — |
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 NCT06308653, 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 Oct 21, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06308653 live on ClinicalTrials.gov.