Recruiting
Presynaptic Imaging in Major Depressive Episodes After COVID-19
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.
ClinicalTrials.gov IDNCT06086366
PhaseNot Applicable
Enrollment90
SponsorCentre for Addiction and Mental Health
Age18 Years – 75 Years
SexALL
About this study
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.
Interventions
- 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
Primary outcomes
- Vesicular Monoamine Transporter 2 Binding Potential (VAMT2 BPND) (within 3 to 4 weeks after initiation of screening)
- Synaptic Vesicle Glycoprotein 2A Total Distribution Volume (SV2A VT) (within 3 to 4 weeks after initiation of screening)
Eligibility information
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
Study locations
- Centre for Addiction and Mental Health, Toronto, Ontario Canada
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-28.