Actively Recruiting
Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST)
Led by Centre for Addiction and Mental Health · Updated on 2025-05-04
12
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 65 years old
- Capacity to provide informed consent
- Signed informed consent form
- Willingness to comply with all study procedures
- Ability to read and understand English for consent and questionnaires
- Primary DSM-5 diagnosis of non-psychotic Major Depressive Disorder (MDD), single or recurrent
- Treatment-resistant depression with baseline HamD-17 score > 14 and failure to respond to two or more adequate antidepressant trials
- Ability to take oral medication
- Use of highly effective contraception for at least 3 months prior and during study if capable of becoming pregnant
- Willingness to taper off current antidepressant and antipsychotic medications before baseline visit with physician approval
- Agreement to follow lifestyle considerations throughout the study
You will not qualify if you...
- Pregnant, breastfeeding, or intending to become pregnant during the study
- Treatment with another investigational drug or intervention within 30 days prior to screening
- Initiated psychotherapy within 12 weeks prior to screening
- DSM-5 substance use disorder diagnosis within 6 months (tobacco allowed)
- Active suicidal thoughts with intent and plan
- Lifetime diagnosis of schizophrenia-spectrum, psychotic, bipolar I or II, obsessive-compulsive, paranoid personality, borderline personality, or neurocognitive disorders
- First-degree relative with schizophrenia-spectrum, psychotic, or bipolar I disorder
- Contraindications to psilocybin including drug allergies, recent stroke, uncontrolled hypertension, cardiac conditions, or moderate to severe kidney or liver impairment
- Prolonged QTc or related heart risk factors
- Allergy or contraindication to risperidone
- History of traumatic brain injury or neurological/neurodegenerative disorder
- Unable or unwilling to undergo PET or MRI scanning
- Blood disorders or use of anticoagulants
- Disabilities preventing study completion including sensory or physical impairments
- Exceeding allowed radiation exposure limits
- Any other significant physical illness that may interfere with study or pose health risks
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J1H4
Actively Recruiting
Research Team
M
Muhammad Ishrat Husain, MBBS, MD
CONTACT
A
Alexandria Coles, MSc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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