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NCT06308653 · ClinicalTrials.gov registry record · Phase 3
Psilocybin for Major Depressive Disorder (MDD)
A Phase 3 study of Depressive Disorder, Major, sponsored by Usona Institute.
- Active
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
- 20
- Study locations
NCT06308653: Active Phase 3 study of Depressive Disorder, Major, sponsored by Usona Institute.
NCT06308653 is a Phase 3 study of Depressive Disorder, Major that is active but no longer recruiting, run by Usona Institute. The registered enrollment target is 240 participants, roughly in line with the 238-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target. The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06308653, a Phase 3 study of Depressive Disorder, Major, is active but no longer recruiting, sponsored by Usona Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition. The total (composite) MADRS score is used as the endpoint.
Conditions Studied
Interventions
- DRUG Psilocybin 25 mg
- DRUG Inactive Placebo
- DRUG Psilocybin 5 mg
- BEHAVIORAL Psychosocial Support
Study Locations (20)
California
- Kadima Neuropsychiatry Institute - La Jolla
- West LA VA Medical Center - Mental Health Department - Los Angeles
- Pacific Neuroscience Institute (PNI) at Saint John's Physician Partners - Santa Monica
- Psychedelic Science Institute - Santa Monica
Florida
- Clinical Neuroscience Solutions Inc. - Jacksonville
- Innovative Clinical Research, Inc. - Lauderhill
- Clinical Neuroscience Solutions, Inc. - Orlando
Arkansas
- Preferred Research Partners-NWA, LLC - Fayetteville
- Preferred Research Partners, Inc. - Little Rock
Georgia
- Emory University - Atlanta
- CenExel iResearch, LLC - Decatur
Maryland
- Johns Hopkins School of Medicine, Center for Psychedelic and Consciousness Research - Baltimore
- Sunstone Medical PC - Rockville
Alabama
- University of Alabama Clinical Research Unit - Birmingham
Colorado
- Mountain View Clinical Research - Denver
Connecticut
- Connecticut Mental Health Center, Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2024-03-13 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 3 |
What the registry record for NCT06308653 still lists
NCT06308653 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 238-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target.
The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 4 interventions - of which Psilocybin 25 mg is the first listed.
NCT06308653 names 20 study sites across 12 states, led by California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06308653 about?
NCT06308653 is a clinical study titled "Psilocybin for Major Depressive Disorder (MDD)". 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 ...
What is the current status of trial NCT06308653?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2024-03-13. Estimated completion is 2026-12-30.
What conditions does trial NCT06308653 study?
This clinical trial studies the following conditions: Depressive Disorder, Major.
What interventions are being tested in trial NCT06308653?
The interventions under investigation include: Psilocybin 25 mg (DRUG), Inactive Placebo (DRUG), Psilocybin 5 mg (DRUG), Psychosocial Support (BEHAVIORAL).
Who is sponsoring clinical trial NCT06308653?
This trial is sponsored by Usona Institute, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06308653 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depressive Disorder, Major
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06308653's enrollment target sits among peer trials
240 19th of 52 higher than 33 of 52 other Depressive Disorder, Major trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder, Major trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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