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

This Phase II interventional trial (n=12) will evaluate the effects of psilocybin (25mg) with and without risperidone (1mg) on synaptic density in adults with treatment-resistant depression (TRD).

The study, led by the Centre for Addiction and Mental Health and conducted by Principal Investigator Dr Muhammad Ishrat Husain, aims to integrate PET imaging into psilocybin trials to determine if its antidepressant effects are associated with changes in synaptic density.

Participants will receive either psilocybin alone or in combination with risperidone. The feasibility of using PET imaging to assess these effects will be a primary focus, along with evaluating changes in depression severity through the Montgomery-Åsberg Depression Rating Scale (MADRS) and preliminary data on synaptic density in relevant brain regions.

The study is expected to run from August 2024 to August 2026.

Topic Depression Treatment-Resistant Depression
Compound Psilocybin
Country Canada
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 August 2024
End date 31 August 2026
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 12
Sex All
Age 18- 65
Therapy Yes

Trial Details

Limit: 5000 characters. 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.

NCT Number NCT06512220

Data attribution

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