Active — Not RecruitingPhase 3

Psilocybin for Major Depressive Disorder (MDD)

United States238 participantsStarted 2024-03-13

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults ≥18 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. * Meet the DSM-5-TR 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. * Have at least moderate severity of depression symptoms at Screening and Trial Baseline. Exclusion Criteria: * Participants who are pregnant, who intend to become pregnant during the trial, or who are currently nursing. * Have any of the following cardiovascular conditions: coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, clinically-relevant valvular heart disease, pulmonary hypertension, myocardial infarction, a clinically significant ECG abnormality, or tachycardia. * Have elevated blood pressure. * Have neurological conditions such as stroke, including transient ischemic attack, epilepsy, neurodegenerative disease (e.g., dementia, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis, etc.), or brain tumor. * Have severe hepatic or renal impairment. * Have uncontrolled diabetes mellitus or unstable existing thyroid disorder. * Are hepatitis or HIV positive. * Have a positive urine drug test for illicit, non-prescribed, or prohibited substances. * Meet DSM-5-TR criteria for schizophrenia spectrum or other …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 3 trial, which means it's one of the later stages of testing — does that mean there's more safety data available on psilocybin for depression compared to earlier studies, and what does my doctor think the known risks look like at this stage?
2The trial is actively running but no longer enrolling new participants — does that mean this specific study is off the table for me, and are there other psilocybin or similar trials that are currently open and worth looking into?
3The main outcome is measured at Day 43, which suggests a relatively short follow-up window — should I ask about what happens to patients after that point, and whether there's data on how long any benefits or side effects might last?
4Psilocybin involves an altered mental state during the session itself — given my specific health history, are there any psychological or medical reasons my doctor would be concerned about me undergoing that kind of experience?
5Before considering a trial like this, would my doctor recommend trying any standard antidepressant treatments first, or does my situation make exploring psilocybin-based options a reasonable path to discuss now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in central rater Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to Trial Day 43

Timeframe: From Trial Baseline to Trial Day 43

Trial details

NCT IDNCT06308653

SponsorUsona Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-05

View on ClinicalTrials.gov More Depressive Disorder, Major trials