Presynaptic Imaging in Major Depressive Episodes After COVID-19

NCT06086366 | Recruiting DMC

• 1 other identifier: REB#201/2022
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID; Major Depressive Disorder; Major Depressive Episode

Keywords

PET; Long COVID; Major Depressive Disorder; Major Depressive Episode; Anhedonia; Dopamine Neuron Loss

Outcome Measures

Primary Outcomes (2)

• Vesicular Monoamine Transporter 2 Binding Potential (VAMT2 BPND)

  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)

  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

Study Arms (2)

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; Other: [18F]SDM8 PET scan; Other: MRI scan

Healthy Control

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

Other: [11C]DTBZ PET scan; Other: [18F]SDM8 PET scan; Other: MRI scan

Interventions

[11C]DTBZ PET scan OTHER

One \[11C\]DTBZ scan for vesicular monoamine transporter 2 (VMAT2)

COVID-DNP; Healthy Control

[18F]SDM8 PET scan OTHER

One \[18F\]SDM8 scan for synaptic vesicle glycoprotein 2A (SV2A)

COVID-DNP; Healthy Control

MRI scan OTHER

One MRI scan

COVID-DNP; Healthy Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• Age 18 to 75.
• Good general physical health with no active medical conditions based on self-report (except migraine or PASC).
• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Depressive Disorder, Major; Anhedonia

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jeffrey Meyer, M.D., PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karida Liu

CONTACT

416-535-8501; liuyuhan0830@gmail.com

Jeffrey Meyer

CONTACT

416-535-8501; jeffrey.meyer@utoronto.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist and Head, Neurochemical Imaging Program in Mood and Anxiety Disorders, Brain Health Imaging Centre, Campbell Family Mental Health Research Institute

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: October 17, 2023
• Study Start: August 22, 2023
• Primary Completion (Estimated): September 10, 2028
• Study Completion (Estimated): September 10, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)