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Phase 2
Age: 18Years - 64Years
All Genders
ID06072898

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

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

Research Team

E

EMBRACE Team

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