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RECRUITINGOBSERVATIONAL

Presynaptic Imaging in Major Depressive Episodes After COVID-19

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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