RecruitingPhase 2NCT06072898

A Randomized Neuroimaging Trial of Psilocybin in Depression

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

Sponsor

Sunnybrook Health Sciences Centre

Enrollment

50 participants

Start Date

May 28, 2025

Study Type

INTERVENTIONAL

Conditions

Depressive Disorder Major Depressive Disorder

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

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study uses brain imaging (neuroimaging) to understand how psilocybin — the active compound in psychedelic mushrooms — affects the brain in people with depression. Participants receive psilocybin in a supervised clinical setting while researchers track brain changes to understand how it works as a treatment. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with a depressive disorder (single episode or recurring, without psychosis) by a psychiatrist using a standardized interview - Your current depressive episode has lasted at least 3 months - You have a responsible caregiver who can monitor you at home after each session - You have a psychiatrist or GP who can provide follow-up care **You may NOT be eligible if...** - You have a personal or family history of psychosis, bipolar disorder, or schizophrenia - You are currently on antidepressants - You have a history of substance use disorders - You are pregnant or breastfeeding - You have serious medical conditions or are at high risk of suicide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin

Psilocybin (\[3-\[2-(dimethylamino)ethyl\]-1H-indol-4-yl\] dihydrogen phosphate), 25mg PO.

OTHERMicrocrystalline cellulose

MCC (excipient), 25mg PO.

BEHAVIORALSupportive psychotherapy

Supportive psychotherapy in the form of reassurance, integration, and de-escalatory techniques (if needed). Facilitating rapport and a positive environment.