Neuroinflammation in COVID-19 and Depression

NCT04854785 | Completed DMC

• 1 other identifier: 177/2020
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to use state of the art brain imaging technology to investigate neuroinflammation in participants with depression after the respiratory symptoms of coronavirus disease 2019 (COVID-19) have passed.

Conditions

Major Depressive Episode; Covid19

Outcome Measures

Primary Outcomes (2)

• Translocator protein total distribution volume in prefrontal cortex, anterior cingulate cortex, and hippocampus

  PET scan measures in DNP-mild and DNP-moderate compared to healthy controls

  within 3 to 4 weeks after initiation of screening

• Monoamine oxidase B total distribution volume in prefrontal cortex, anterior cingulate cortex, and hippocampus

  PET scan measures in DNP-mild and DNP-moderate compared to healthy controls

  within 3 to 4 weeks after initiation of screening

Study Arms (3)

DNP-mild

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

Other: [18F]FEPPA PET scan; Other: [11C]SL25.1188 PET scan

DNP-moderate

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

Other: [18F]FEPPA PET scan; Other: [11C]SL25.1188 PET scan

Healthy Control Participants

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

Other: [18F]FEPPA PET scan; Other: [11C]SL25.1188 PET scan

Interventions

[18F]FEPPA PET scan OTHER

One \[18F\]FEPPA PET for TSPO VT, and one MRI scan

DNP-mild; DNP-moderate; Healthy Control Participants

[11C]SL25.1188 PET scan OTHER

One \[11C\]SL25.1188 PET scan for MAO-B VT, and one MRI scan

DNP-mild; DNP-moderate; Healthy Control Participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age 18 to 80
• Diagnosis of COVID-19
• Recovered from mild or moderate COVID-19 symptoms. Mild is defined as no evidence of pneumonia or hypoxia. Moderate is defined as presence of clinical symptoms of pneumonia but not severe enough to require ongoing use of supplementary oxygen.
• Recovered from physical COVID-19 symptoms including cough, shortness of breath, fever, chills, or gastrointestinal upset for at least 4 weeks
• New onset major depressive episode (MDE) within 3 months after COVID-19, as verified by the Research Version of Structured Clinical Interview for DSM 5 (SCID-5-RV)
• High-affinity-binder (HAB) or mixed-affinity-binder (MAB) genotype for rs6971 polymorphism, based on saliva genetic testing

You may not qualify if:

• Lifetime history of an autoimmune disease
• Lifetime history of a neurological disease, excluding migraine
• Lifetime diagnosis of Antisocial or Borderline Personality disorder
• Lifetime history of psychotic symptoms prior to COVID-19
• Lifetime diagnosis of Substance of Alcohol Use Disorder
• Use of street drugs, including marijuana, in the past two months
• Presence of cigarette smoking in the past two months
• Positive urine drug or cotinine screen at any timepoint during the study
• Currently pregnant
• Currently breastfeeding
• Use of aspirin or ibuprofen within the past 2 weeks
• Use of any other anti-inflammatory medication or MAO-B inhibitors within the past 4 weeks
• Use of herbal remedies in the past month
• Presence of metal implant, object or electrical devices that are contraindicated for MRI
• Current disorders of coagulation, blood or ongoing use of anticoagulant medication

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

brain scan; also saliva, whole blood, plasma and serum samples will be kept for analysis of genotype, peripheral inflammatory markers and protein binding in relation to brain scan

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jeffrey H Meyer, M.D., PhD

  Brain Health Imaging Centre, Centre for Addiction and Mental Health (CAMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Head, Neurochemical Imaging for Mood Disorders

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 22, 2021
• Study Start: June 14, 2021
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)