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A Randomized Neuroimaging Trial of Psilocybin in Depression | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Randomized Neuroimaging Trial of Psilocybin in Depression

Engaging Mood Brain Circuits With Psilocybin: a Randomized Neuroimaging Trial in Depression

NCT06072898•Sunnybrook Health Sciences Centre

Summary

The goal of this neuroimaging clinical trial is to test whether psilocybin produces significant immediate changes in functional brain activity in networks associated with mood regulation and depression compared to placebo in patients with depression. The trial aims to determine if psilocybin: 1. Changes connectivity within brain networks associated with mood and depression 2. Changes blood flow in brain regions associated with mood and depression Participants will be attend two treatment sessions where they receive an oral medication and supportive psychotherapy. At each session, participants will undergo an MRI scan after drug administration but prior to psychotherapy. Participants will be randomly to assigned to one of two groups that will receive, 1) microcrystalline cellulose (25mg) at the first visit and psilocybin (25mg) at the second visit, or 2) psilocybin (25mg) at both visits, respectively. Differences between groups will be compared to understand what effects on brain activity are specific to psilocybin.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Able and voluntarily willing to provide written informed consent at the screening visit.
•Over 18 and under 65 years old
•Able to attend all study visits and complete all required assessment tools without assistance or alteration
•Have a responsible individual/caregiver who is able to monitor the participant at home for 24 hours after each treatment visit
•Must have a psychiatrist and/or general practitioner who is able to provide psychiatric follow-up care
•Mini International Neuropsychiatric Interview (MINI)-confirmed diagnosis of depressive disorder, recurrent or single episode, without psychotic features where the duration of the current episode is at least 3 months
•Depression of at least moderate severity as defined by a Hamilton Depression Rating Scale (HAMD-17) score \>17

Exclusion Criteria

•Uncontrolled or insulin-dependent diabetes
•Women who are pregnant (self-report or via urine test), nursing, or planning a pregnancy during the timespan of the study
•History of seizure disorder except for seizures from electroconvulsive therapy and/or febrile seizures in childhood
•History of stroke, recent myocardial infarction (\< 1 year from signing of ICF), uncontrolled hypertension (blood pressure \> 140/90 mmHg) or clinically significant arrhythmia within 1 year of signing the ICF
•Abnormal and clinically significant results on a physical examination performed within one month of study participation by a general practitioner, vital signs, ECG, or laboratory test at screening
•QTc prolongation on ECG defined by \> 450 ms in males and \> 460 ms in females in V5 on a 12-lead ECG
•Positive urine drug screen for illicit drugs or drugs of abuse at screening, a week prior to treatment, and during the trial (any positive urine drug test will be reviewed with participants to determine the pattern of use and eligibility will be determined at the investigator's discretion)
•Serial blood counts to achieve a value to meet eligibility -- abnormalities in screening/baseline blood work (complete blood counts, electrolyte panel, etc.) will be reviewed by MD, then repeated serially until abnormalities resolve
•Any symptoms consistent with psychosis
•Any symptoms consistent with hypomania and/or mania as assessed by a psychiatrist
+14 more criteria

Locations (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Key Dates

Start Date

March 25, 2025

Primary Completion Date

June 1, 2027

Completion Date

June 1, 2028

Last Updated

June 11, 2025

Enrollment

ESTIMATED participants

Conditions

Depressive DisorderMajor Depressive Disorder

Interventions

Psilocybin

DRUG

Microcrystalline cellulose

OTHER

Supportive psychotherapy

BEHAVIORAL

Contacts

EMBRACE Team

CONTACT

416-480-4085 embrace@sunnybrook.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Randomized Neuroimaging Trial of Psilocybin in Depression

Inclusion Criteria

Exclusion Criteria

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