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Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST)

Study acronym: SYNVEST
StatusRecruiting
PhasePhase 2
Started2025-04-21
View on ClinicalTrials.gov ↗

Amendment history

2026-07-29
Study Status, Study Description, Contacts/Locations v5
Study sitescontacts updated at 1 of 1 site
2026-05-28
Study Status, Outcome Measures, Contacts/Locations, Document Section v4
Primary endpoints1 entry, revised
[...] on of psilocybin (25 mg) with and without risperidone (1 mg) in adults with TRD.
Study sitescontacts updated at 1 of 1 site
2025-04-30
Not Yet Recruiting→Recruiting Study Status, Conditions, Outcome Measures, Eligibility, Contacts/Locations, Document Section v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-03→2027-04
Start dateestimated 2025-03→confirmed 2025-04-21
Eligibility criteria+110 characters
Inclusion Criteria: Adults 18 to 65 years old; Must be deemed to have capacity t [...] rials of antidepressants at an adequate dosage and duration (an antidepressant resistance rating score of three or more is considered an adequate trial) based on the Antidepressant Treatment History Form (ATHF); t [...] yle Considerations (section 4.5) throughout study duration. o • Exclusion Criteria: Pregnant as assessed by a urine pregnancy test at Screening [...]
Study sitesdetails revised at 1 of 1 site
2025-02-10
Study Status v2
Primary completion date2026-08→2027-03
Completion date2026-08→2027-09
Start date2024-08→2025-03
2024-07-22
Study Status, Outcome Measures v1
Re-verified, no change to tracked fields
2024-07-16
Original filing
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. In healthy volunteers, the psychedelic effects of psilocybin have been shown to be blocked by administration of certain medications such as risperidone. The purpose of this study is to use an established SV2A radiotracer produced at our Centre to determine the feasibility of integrating PET imaging in to psilocybin trials. The preliminary imaging data will assess whether psilocybin's antidepressant effects are related to changes in synaptic density in adults with TRD, and whether any changes in synaptic density are associated with psilocybin's actions on the 5-HT2AR.
Trial Details
NCT Number NCT06512220
Lead Sponsor Centre for Addiction and Mental Health
Conditions Treatment Resistant Depression
Enrollment 12 participants
Start Date 2025-04-21
Primary Completion 2027-04 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-30