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Clinical Trials/NCT06086366
NCT06086366
Recruiting
Not Applicable

Presynaptic Imaging in Major Depressive Episodes After COVID-19

Centre for Addiction and Mental Health1 site in 1 country90 target enrollmentAugust 22, 2023

Overview

Phase
Not Applicable
Intervention
[11C]DTBZ PET scan
Conditions
Long COVID
Sponsor
Centre for Addiction and Mental Health
Enrollment
90
Locations
1
Primary Endpoint
Synaptic Vesicle Glycoprotein 2A Total Distribution Volume (SV2A VT)
Status
Recruiting
Last Updated
2 months ago

Overview

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.

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

Registry
clinicaltrials.gov
Start Date
August 22, 2023
End Date
September 10, 2028
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

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
  • See "Positive COVID-19 diagnosis" listed after inclusion/

Exclusion Criteria

  • for a description of how this is determined.
  • Age 18 to
  • 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

Arms & Interventions

COVID-DNP

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

Intervention: [11C]DTBZ PET scan

COVID-DNP

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

Intervention: [18F]SDM8 PET scan

COVID-DNP

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

Intervention: MRI scan

Healthy Control

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

Intervention: [11C]DTBZ PET scan

Healthy Control

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

Intervention: [18F]SDM8 PET scan

Healthy Control

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

Intervention: MRI scan

Outcomes

Primary Outcomes

Synaptic Vesicle Glycoprotein 2A Total Distribution Volume (SV2A VT)

Time Frame: 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

Vesicular Monoamine Transporter 2 Binding Potential (VAMT2 BPND)

Time Frame: 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.

Study Sites (1)

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