Presynaptic Imaging in Major Depressive Episodes After COVID-19 (PCOV)

February 9, 2026 updated by: Jeff Meyer, Centre for Addiction and Mental Health
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • Centre for Addiction and Mental Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Recovered from mild to moderate COVID-19 respiratory symptoms with subsequent onset of COVID-DNP

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
The investigators will determine if SV2A VT is changed in ventral striatum and dorsal putamen in COVID-DNP
within 3 to 4 weeks after initiation of screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2023

Primary Completion (Estimated)

September 10, 2028

Study Completion (Estimated)

September 10, 2028

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

October 15, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB#201/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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