Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST)
Recruiting · Toronto, Ontario
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Study care at no cost to you
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Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
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Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Adults age 18 to 65
- •Have capacity to provide informed consent and can sign the consent form
- •Primary diagnosis of non-psychotic major depressive disorder (MDD), single or recurrent, based on SCID-5
- •Treatment-resistant depression, defined by a baseline HamD-17 score > 14 and not responding to two or more antidepressant trials at adequate dose/duration
- •Able to read and communicate in English well enough for consent and questionnaires
🚫 You may not be able to join if…
- •Pregnant, trying to become pregnant during the study, or breastfeeding (checked by urine pregnancy test at screening)
- •Any DSM-5 lifetime diagnosis of schizophrenia-spectrum disorder, obsessive-compulsive disorder, psychotic disorder (with the noted exceptions), bipolar I or II disorder, paranoid personality disorder, borderline personality disorder, or neurocognitive disorder
- •Active suicidal ideation with intent and plan (as determined by item 3 of the HamD-17)
- •A relative or absolute contraindication to psilocybin, including drug allergy, recent stroke, uncontrolled hypertension, low or labile blood pressure, recent myocardial infarction, heart rhythm problems, severe coronary artery disease, or moderate to severe kidney or liver impairment
- •Unable or unwilling to undergo PET or MRI scanning (for example, claustrophobia or a pacemaker)
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 18–65
- ✓Have Depression
- !Some conditions may not be a fit: Heart / cardiovascular disease, High blood pressure
- !Not for people who are pregnant or breastfeeding
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT06512220 · Locations: Ontario