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

Study acronym: PSI-TNT
StatusRecruiting
PhasePhase 2
Started2026-07-03
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Apr 1, 2028 → Jul 2028
See other at-risk trials from Centre for Addiction and Mental Health

Amendment history

2026-08-19
Study Status, Contacts/Locations v4
Study sitescontacts updated at 2 of 2 sites
2026-07-29
Study Status, Contacts/Locations v3
Recruitment opened
Primary completion pushed: 2028-04-01 → 2028-07
Completion pushed: 2028-12-01 → 2029-01
Study sitesdetails revised at 1 of 2 sites
2026-07-28
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-04-01→2028-07
Completion date2028-12-01→2029-01
Start dateestimated 2026-04-01→confirmed 2026-07-03
Study sitesdetails revised at 2 of 2 sites
2026-03-16
Study Status, Sponsor/Collaborators v1
Re-verified, no change to tracked fields
2025-10-02
Original filing
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.
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 2026-08-21