Status:

UNKNOWN

Presynaptic Imaging in Major Depressive Episodes After COVID-19

Lead Sponsor:

Centre for Addiction and Mental Health

Conditions:

Long COVID

Major Depressive Disorder

Eligibility:

All Genders

18-75 years

Brief Summary

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...

Detailed Description

Participants will undergo two positron emission tomography (PET) scans, one \[11C\]DTBZ scan (for vesicular monoamine transporter 2 (VMAT2) and one \[18F\]SDM8 scan (for synaptic vesicle glycoprotein ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 22 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 10 2025

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT06086366

Start Date

August 22 2023

End Date

September 10 2025

Last Update

October 17 2023

Active Locations (1)

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1

Centre for Addiction and Mental Health

Toronto, Ontario, Canada