RECRUITINGOBSERVATIONAL
Presynaptic Imaging in Major Depressive Episodes After COVID-19
About This Trial
The goal of this observational study focuses on understanding and addressing a subset of persistent neuropsychiatric symptoms occurring within 3 months after mild to moderate COVID-19 infection (COVID-DNP). COVID-DNP encompasses major depressive episodes (MDE) with or without additional neuropsychiatric symptoms.
Who May Be Eligible (Plain English)
Who May Qualify:
- New onset MDE within 3 months after mild or moderate COVID-19, with MDE verified by the research version SCID for DSM 5. See "Positive COVID-19 diagnosis" listed after inclusion/exclusion criteria for a description of how this is determined.
- Age 18 to 75.
- Good general physical health with no active medical conditions based on self-report (except migraine or PASC).
Who Should NOT Join This Trial:
- Use of antidepressants in the previous month (6 weeks for fluoxetine).
- Use of stimulant medication affecting dopamine release in the previous month
- Use of antipsychotics in the previous month
- History of neurological disease (except migraine, and PASC) based on self-report
- Use of medications or herbal products or natural health products with central nervous system effects in past 2 weeks based on self-report
- Presence of cigarette smoking in the past two months, based on self-report
- Lifetime diagnosis of severe Substance or Alcohol Use Disorder, or diagnosis of mild to moderate Substance or Alcohol Use Disorder in the past two years, based on self-report and verified by the Research Version of Structured Clinical Interview for Diagnostic and Statistical Manual-5 (SCID-5-RV)
- Use of recreational drugs, including marijuana, in the past two months, based on self-report and verified by the Research Version of Structured Clinical Interview for Diagnostic and Statistical Manual-5 (SCID-5-RV)
- Positive urine drug or cotinine screen at any timepoint during the study
- History of psychotic symptoms secondary to schizophrenia, schizophreniform, bipolar disorder, or brief psychotic disorder prior to COVID-19, based on self-report and verified by the Research Version of Structured Clinical Interview for Diagnostic and Statistical Manual-5 (SCID-5-RV)
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* New onset MDE within 3 months after mild or moderate COVID-19, with MDE verified by the research version SCID for DSM 5. See "Positive COVID-19 diagnosis" listed after inclusion/exclusion criteria for a description of how this is determined.
* Age 18 to 75.
* Good general physical health with no active medical conditions based on self-report (except migraine or PASC).
Exclusion Criteria:
* Use of antidepressants in the previous month (6 weeks for fluoxetine).
* Use of stimulant medication affecting dopamine release in the previous month
* Use of antipsychotics in the previous month
* History of neurological disease (except migraine, and PASC) based on self-report
* Use of medications or herbal products or natural health products with central nervous system effects in past 2 weeks based on self-report
* Presence of cigarette smoking in the past two months, based on self-report
* Lifetime diagnosis of severe Substance or Alcohol Use Disorder, or diagnosis of mild to moderate Substance or Alcohol Use Disorder in the past two years, based on self-report and verified by the Research Version of Structured Clinical Interview for Diagnostic and Statistical Manual-5 (SCID-5-RV)
* Use of recreational drugs, including marijuana, in the past two months, based on self-report and verified by the Research Version of Structured Clinical Interview for Diagnostic and Statistical Manual-5 (SCID-5-RV)
* Positive urine drug or cotinine screen at any timepoint during the study
* History of psychotic symptoms secondary to schizophrenia, schizophreniform, bipolar disorder, or brief psychotic disorder prior to COVID-19, based on self-report and verified by the Research Version of Structured Clinical Interview for Diagnostic and Statistical Manual-5 (SCID-5-RV)
* Currently pregnant, based on self-report or positive pregnancy test at any timepoint during the study, in females (in our PET Centre females up to 65 years of age are given a urine pregnancy test prior to every PET scan)
* Breastfeeding (for females)
* Current disorders of coagulation, blood or ongoing use of anticoagulant medication, based on self-report
* Claustrophobia, based on self-report
* Weight over 400lbs and height over 7ft (requirements for fitting in the scanners and hospital gowns)
* Presence of metal implant, object or electrical devices that are contraindicated for MRI, based on self-report
* Severe allergic reaction to alcohol
Treatments Being Tested
OTHER
[11C]DTBZ PET scan
One \[11C\]DTBZ scan for vesicular monoamine transporter 2 (VMAT2)
OTHER
[18F]SDM8 PET scan
One \[18F\]SDM8 scan for synaptic vesicle glycoprotein 2A (SV2A)
OTHER
MRI scan
One MRI scan
Locations (1)
Centre for Addiction and Mental Health
Toronto, Ontario, Canada