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Study identifier: NCT06308653 Synced from ClinicalTrials.gov · August 06, 2026
● Study status: Active Not Recruiting

Psilocybin for Major Depressive Disorder (MDD)

Condition: Depressive Disorder, Major  ·  Sponsor: Usona Institute

PhasePhase 3
Planned participants238
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

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No contact information is available for this study as per the public registry record.

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Locations (29)

University of Alabama Clinical Research UnitBirmingham, Alabama, United States
Preferred Research Partners-NWA, LLCFayetteville, Arkansas, United States
Preferred Research Partners, Inc.Little Rock, Arkansas, United States
Kadima Neuropsychiatry InstituteLa Jolla, California, United States
West LA VA Medical Center - Mental Health DepartmentLos Angeles, California, United States
Pacific Neuroscience Institute (PNI) at Saint John's Physician PartnersSanta Monica, California, United States
Psychedelic Science InstituteSanta Monica, California, United States
Mountain View Clinical ResearchDenver, Colorado, United States
Connecticut Mental Health Center, Yale UniversityNew Haven, Connecticut, United States
Clinical Neuroscience Solutions Inc.Jacksonville, Florida, United States
Innovative Clinical Research, Inc.Lauderhill, Florida, United States
Clinical Neuroscience Solutions, Inc.Orlando, Florida, United States

+ 17 more locations — full list on the registry record.

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