Actively Recruiting
Psilocybin and Brain Activity Changes in Adults With Depression A Randomized Neuroimaging Study
Led by Sunnybrook Health Sciences Centre · Updated on 2026-03-30
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial studies adults aged 18 to 64 with moderate depression to see if psilocybin causes immediate changes in brain activity related to mood and depression. Researchers compare brain connectivity and blood flow after taking psilocybin versus a placebo to understand its effects on mood regulation. The study is randomized and carefully monitors brain changes using MRI scans. Participants attend two treatment sessions where they receive oral medication and supportive psychotherapy. One group takes a placebo at the first visit and psilocybin at the second, while the other group receives psilocybin at both visits. MRI scans are done after medication but before psychotherapy to observe brain activity changes. Supportive psychotherapy helps create a positive and reassuring environment during treatments. During the study, participants complete various depression and mood assessments up to six weeks after treatment. Researchers measure brain blood flow and connectivity changes within three weeks. Additional tests evaluate depressive symptoms, anxiety, cognitive function, and mystical experiences. Participants must have support at home for 24 hours after treatment and ongoing psychiatric care. The study lasts up to eight weeks, including follow-up assessments to ensure safety and monitor effects.
CONDITIONS
Brief Title
A Randomized Neuroimaging Trial of Psilocybin in Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and voluntarily willing to provide written informed consent at the screening visit
- Over 18 and under 65 years old
- Able to complete all required assessment tools without assistance or alteration
- Have a responsible individual/caregiver to monitor you at home for 24 hours after each treatment visit
- Have a psychiatrist and/or general practitioner able to provide psychiatric follow-up care
- Have a confirmed diagnosis of major depressive disorder (MDD), recurrent or single episode without psychotic features, with current episode lasting at least 3 months
- Depression of at least moderate severity defined by a Hamilton Depression Rating Scale (HAMD-17) score greater than 17
You will not qualify if you...
- History or current diagnosis of bipolar I/II disorder, schizophrenia, schizoaffective disorder, psychotic or delusional disorder
- Clinical diagnosis of antisocial, paranoid, or borderline personality disorder
- Depression secondary to other medical conditions or bipolar disorders
- Family history of schizophrenia, primary psychotic disorder, or bipolar disorder
- Symptoms consistent with psychosis or mania/hypomania
- Suicide attempt requiring hospitalization in the past year
- Behavior incompatible with safe exposure to psilocybin
- Women who are pregnant, nursing, or planning pregnancy
- Lifetime history of hallucinogen substance use disorder or substance-induced psychosis
- Positive urine drug screen for illicit drugs at screening or during trial
- Abnormal clinical examination, vital signs, ECG, or lab tests including QTc prolongation
- Uncontrolled or insulin-dependent diabetes
- History of seizure disorder except specific types
- Diagnosis of neurocognitive disorders
- Recent stroke, heart attack, uncontrolled hypertension, or serious arrhythmia
- Other major illnesses interfering with study or participant safety
- Psilocybin or other psychedelic use within 12 months prior to screening or during current depressive episode
- History of moderate or greater substance or alcohol use disorder in past year
- Current or recent participation in other interventional depression studies
- Abnormal blood counts not resolved by serial testing
Research Team
E
EMBRACE Team
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here