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Recruiting NCT06086366

Presynaptic Imaging in Major Depressive Episodes After COVID-19

— Observational Long COVID Major Depressive Disorder Major Depressive Episode

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [11C]DTBZ PET scan, [18F]SDM8 PET scan, MRI scan.
Who it may be relevant to
Registry conditions: Long COVID, Major Depressive Disorder, Major Depressive Episode. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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 2A (SV2A)), as well as one magnetic resonance imaging (MRI) scan.

The main question\[s\] it aims to answer are:

1. The investigators will determine if VMAT2 binding potential (VMAT2 BPND) is reduced in ventral striatum and dorsal putamen in COVID-DNP. 2. The investigators will determine if SV2A total distribution volume (SV2A VT) is reduced in ventral striatum and dorsal putamen in COVID-DNP

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 outcome measures

  • Vesicular Monoamine Transporter 2 Binding Potential (VAMT2 BPND) [Time frame: within 3 to 4 weeks after initiation of screening]
  • Synaptic Vesicle Glycoprotein 2A Total Distribution Volume (SV2A VT) [Time frame: within 3 to 4 weeks after initiation of screening]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Canada · 1 center
  • Centre for Addiction and Mental Health — Toronto

Identifiers

NCT: NCT06086366 · REB#201/2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗