Major Depressive EpisodeNCT04854785
Neuroinflammation in COVID-19 and Depression
An observational study of Major Depressive Episode and Covid19, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Episode, Covid19
- What is being tested?
- [18F]FEPPA PET scan and [11C]SL25.1188 PET scan
- How many people
- 77 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jun 2021to 21 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants that have recovered from mild or moderate COVID-19 respiratory symptoms and have a new onset major depressive episode (MDE).
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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).
- 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:
- 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.
- TSPO VT and MAO-B VT will be positively correlated in the PFC, ACC and hippocampus in COVID-DNP.
- Conditions
- Major Depressive Episode, Covid19
- Being tested
- [18F]FEPPA PET scan, [11C]SL25.1188 PET scan
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FEPPA PET scanOther
One [18F]FEPPA PET for TSPO VT, and one MRI scan
[11C]SL25.1188 PET scanOther
One [11C]SL25.1188 PET scan for MAO-B VT, and one MRI scan
| Study group | Role | What they receive |
|---|---|---|
| DNP-mild | Participants that have recovered from mild COVID-19 respiratory symptoms and have a new onset major depressive episode (MDE). Receives: 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). Receives: 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. Receives: Other: [18F]FEPPA PET scan; Other: [11C]SL25.1188 PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: within 3 to 4 weeks after initiation of screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start14 Jun 2021
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive EpisodeStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Meyer, Centre for Addiction and Mental Health
- Investigators
- Jeffrey H Meyer, M.D., PhD, Principal investigator, Brain Health Imaging Centre, Centre for Addiction and Mental Health (CAMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854785
- Sponsor's protocol ID
- 177/2020
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2021
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Neuroinflammation in COVID-19 and Persistent Depression With/Without Other Neuropsychiatric Symptoms
- ClinicalTrials.gov ID
- NCT04854785
- Acronym / sponsor ID
- 177/2020
- Conditions
- Major Depressive Episode, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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).
- 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:
- 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.
- TSPO VT and MAO-B VT will be positively correlated in the PFC, ACC and hippocampus in COVID-DNP.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DNP-mild | – | Other: [18F]FEPPA PET scan, Other: [11C]SL25.1188 PET scanParticipants that have recovered from mild COVID-19 respiratory symptoms and have a new onset major depressive episode (MDE). |
| DNP-moderate | – | Other: [18F]FEPPA PET scan, Other: [11C]SL25.1188 PET scanParticipants that have recovered from moderate COVID-19 respiratory symptoms and have a new onset major depressive episode (MDE). |
| Healthy Control Participants | – | Other: [18F]FEPPA PET scan, Other: [11C]SL25.1188 PET scanParticipants in good physical health, age- and sex-matched to Group 1 and 2 participants. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants that have recovered from mild or moderate COVID-19 respiratory symptoms and have a new onset major depressive episode (MDE).
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FEPPA PET scanOne [18F]FEPPA PET for TSPO VT, and one MRI scan | Other | DNP-mild, DNP-moderate, Healthy Control Participants |
| [11C]SL25.1188 PET scanOne [11C]SL25.1188 PET scan for MAO-B VT, and one MRI scan | Other | DNP-mild, DNP-moderate, Healthy Control Participants |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey H Meyer, M.D., PhD principal investigator
Brain Health Imaging Centre, Centre for Addiction and Mental Health (CAMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Episode and Covid19, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Translocator protein total distribution volume in prefrontal cortex, anterior cingulate cortex, and hippocampus (time frame: within 3 to 4 weeks after initiation of screening). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.