PCOV: Presynaptic Imaging in Major Depressive Episodes After COVID-19

Sponsor
Centre for Addiction and Mental Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT06086366
Collaborator
(none)
90
1
24.6
3.7

Study Details

Study Description

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-DNP). COVID-DNP encompasses major depressive episodes (MDE) with or without additional neuropsychiatric symptoms.

Condition or Disease Intervention/Treatment Phase
  • Other: [11C]DTBZ PET scan
  • Other: [18F]SDM8 PET scan
  • Other: MRI scan

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Presynaptic Imaging in Major Depressive Episodes After COVID-19
Actual Study Start Date :
Aug 22, 2023
Anticipated Primary Completion Date :
Sep 10, 2025
Anticipated Study Completion Date :
Sep 10, 2025

Arms and Interventions

Arm Intervention/Treatment
COVID-DNP

Participants that have recovered from mild or moderate COVID-19 respiratory symptoms and have a new onset major depressive episode (MDE).

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

Healthy Control

Participants in good physical health, age- and sex-matched to Group 1 and 2 participants.

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

Outcome Measures

Primary Outcome Measures

  1. Vesicular Monoamine Transporter 2 Binding Potential (VAMT2 BPND) [within 3 to 4 weeks after initiation of screening]

    The investigators will determine if VMAT2 BPND is changed in ventral striatum and dorsal putamen in COVID-DNP.

  2. Synaptic Vesicle Glycoprotein 2A Total Distribution Volume (SV2A VT) [within 3 to 4 weeks after initiation of screening]

    The investigators will determine if SV2A VT is changed in ventral striatum and dorsal putamen in COVID-DNP

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre for Addiction and Mental Health Toronto Ontario Canada

Sponsors and Collaborators

  • Centre for Addiction and Mental Health

Investigators

  • Principal Investigator: Jeffrey Meyer, M.D., PhD, Centre for Addiction and Mental Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeff Meyer, Scientist and Head, Neurochemical Imaging Program in Mood and Anxiety Disorders, Brain Health Imaging Centre, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT06086366
Other Study ID Numbers:
  • REB#201/2022
First Posted:
Oct 17, 2023
Last Update Posted:
Oct 17, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jeff Meyer, Scientist and Head, Neurochemical Imaging Program in Mood and Anxiety Disorders, Brain Health Imaging Centre, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 17, 2023