Neuroinflammation in COVID-19 and Depression

April 17, 2025 updated by: Jeff Meyer, Centre for Addiction and Mental Health

Imaging Neuroinflammation in COVID-19 and Persistent Depression With/Without Other Neuropsychiatric Symptoms

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will undergo two positron emission tomography (PET) scans: one [18F]FEPPA scan (for translocator protein (TSPO)) and one [11C]SL25.1188 scan (for monoamine oxidase B (MAO-B)) - as well as one magnetic resonance imaging (MRI) scan.

The primary hypotheses are:

  1. TSPO total distribution volume (TSPO VT) and MAO-B total distribution volume (MAO-B VT) are greater in the prefrontal cortex (PFC), anterior cingulate cortex (ACC), and hippocampus in COVID-19 with new onset, persistent major depressive episode (MDE) with or without other neuropsychiatric symptoms after recovery from mild respiratory symptoms (DNP-mild).
  2. TSPO VT and MAO-B VT are greater in the PFC, ACC, and hippocampus in COVID-19 with new onset, persistent MDE with or without other persistent neuropsychiatric symptoms after recovery from moderate respiratory symptoms (DNP-moderate).

Exploratory hypotheses are:

  1. Greater TSPO VT and MAO-B VT in the PFC, ACC, and hippocampus will be positively associated with severity of MDE symptoms and poorer performance on cognitive tasks.
  2. TSPO VT and MAO-B VT will be positively correlated in the PFC, ACC and hippocampus in COVID-DNP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 1R8
        • Centre for Addiction and Mental Health

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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).

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Claustrophobia
  • Weight over 400lbs and height over 7ft
  • History of undergoing a number of PET scans that will lead participants to exceed the annual (20mSv) / lifetime (8 PET scans) radiation by completing this study
  • Current participation in another research study

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
One [18F]FEPPA PET for TSPO VT, and one MRI scan
Other: [11C]SL25.1188 PET scan
One [11C]SL25.1188 PET scan for MAO-B VT, and one MRI 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
One [18F]FEPPA PET for TSPO VT, and one MRI scan
Other: [11C]SL25.1188 PET scan
One [11C]SL25.1188 PET scan for MAO-B VT, and one MRI scan
Healthy Control Participants
Participants in good physical health, age- and sex-matched to Group 1 and 2 participants.
Other: [18F]FEPPA PET scan
One [18F]FEPPA PET for TSPO VT, and one MRI scan
Other: [11C]SL25.1188 PET scan
One [11C]SL25.1188 PET scan for MAO-B VT, and one MRI scan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Translocator protein total distribution volume in prefrontal cortex, anterior cingulate cortex, and hippocampus
Time Frame: within 3 to 4 weeks after initiation of screening
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
Time Frame: within 3 to 4 weeks after initiation of screening
PET scan measures in DNP-mild and DNP-moderate compared to healthy controls
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre for Addiction and Mental Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffrey H Meyer, M.D., PhD, Brain Health Imaging Centre, Centre for Addiction and Mental Health (CAMH)

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 177/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

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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