Clinical Trial

Evaluating the Role of Psilocybin Monitors in Psilocybin Therapy for Treatment Resistant Depression

Study acronym: PSI-TNT
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychological support in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. The purpose of this study is to determine the role of psilocybin monitors on the effects of psilocybin therapy in adults with treatment resistant depression.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-07-30
notable Primary completion pushed: 2028-04-01 -> 2028-07 2026-07-30
minor Completion pushed: 2028-12-01 -> 2029-01 2026-07-30
Trial Details
NCT Number NCT07211438
Lead Sponsor Centre for Addiction and Mental Health
Collaborators: University Health Network, Toronto
Conditions Treatment-Resistant Depression
Enrollment 40 participants
Start Date 2026-07-03
Primary Completion 2028-07 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-30