Long COVIDPCOVNCT06086366
Presynaptic Imaging in Major Depressive Episodes After COVID-19
An observational study of Long COVID and Major Depressive Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Long COVID, Major Depressive Disorder, Major Depressive Episode
- What is being tested?
- [11C]DTBZ PET scan, [18F]SDM8 PET scan and MRI scan
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 22 Aug 2023to 10 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recovered from mild to moderate COVID-19 respiratory symptoms with subsequent onset of COVID-DNP
Who may be able to join
- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario
Yuhan Liu, (416) 535-8501 ext. 39674, yuhan.liu@camh.ca
About this study
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.
Read the 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:
- The investigators will determine if VMAT2 binding potential (VMAT2 BPND) is reduced in ventral striatum and dorsal putamen in COVID-DNP.
- The investigators will determine if SV2A total distribution volume (SV2A VT) is reduced in ventral striatum and dorsal putamen in COVID-DNP
- Being tested
- [11C]DTBZ PET scan, [18F]SDM8 PET scan, MRI scan
- Keywords
- PET, Long COVID, Major Depressive Disorder, Major Depressive Episode, Anhedonia, Dopamine Neuron Loss
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Depressive Disorder, Major, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]DTBZ PET scanOther
One [11C]DTBZ scan for vesicular monoamine transporter 2 (VMAT2)
[18F]SDM8 PET scanOther
One [18F]SDM8 scan for synaptic vesicle glycoprotein 2A (SV2A)
MRI scanOther
One MRI scan
| Study group | Role | What they receive |
|---|---|---|
| COVID-DNP | Participants that have recovered from mild or moderate COVID-19 respiratory symptoms and have a new onset major depressive episode (MDE). Receives: 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. Receives: Other: [11C]DTBZ PET scan; Other: [18F]SDM8 PET scan; Other: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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 posted17 Oct 2023
- Study start22 Aug 2023
- Primary completion10 Sep 2028 (estimated)
- Study completion10 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
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 Meyer, M.D., PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086366
- Sponsor's protocol ID
- REB#201/2022
- Acronym
- PCOV
- Status last verified
- Feb 2026
- First submitted
- 5 Sep 2023
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presynaptic Imaging in Major Depressive Episodes After COVID-19
- ClinicalTrials.gov ID
- NCT06086366
- Acronym / sponsor ID
- PCOV / REB#201/2022
- Keywords
- PET, Long COVID, Major Depressive Disorder, Major Depressive Episode, Anhedonia, Dopamine Neuron Loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 10 Sep 2028 (estimated)
- Study completion
- 10 Sep 2028 (estimated)
- First posted
- 17 Oct 2023 (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 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.
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:
- The investigators will determine if VMAT2 binding potential (VMAT2 BPND) is reduced in ventral striatum and dorsal putamen in COVID-DNP.
- The investigators will determine if SV2A total distribution volume (SV2A VT) is reduced in ventral striatum and dorsal putamen in COVID-DNP
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-DNP | – | Other: [11C]DTBZ PET scan, Other: [18F]SDM8 PET scan, Other: MRI scanParticipants that have recovered from mild or moderate COVID-19 respiratory symptoms and have a new onset major depressive episode (MDE). |
| Healthy Control | – | Other: [11C]DTBZ PET scan, Other: [18F]SDM8 PET scan, Other: MRI scanParticipants in good physical health, age- and sex-matched to Group 1 and 2 participants. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recovered from mild to moderate COVID-19 respiratory symptoms with subsequent onset of COVID-DNP
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| [11C]DTBZ PET scanOne [11C]DTBZ scan for vesicular monoamine transporter 2 (VMAT2) | Other | COVID-DNP, Healthy Control |
| [18F]SDM8 PET scanOne [18F]SDM8 scan for synaptic vesicle glycoprotein 2A (SV2A) | Other | COVID-DNP, Healthy Control |
| MRI scanOne MRI scan | Other | COVID-DNP, Healthy Control |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- 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.
Jeffrey Meyer, M.D., PhD principal investigator
Centre for Addiction and Mental Health
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 Long COVID and Major Depressive Disorder, 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 3 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karida Liu (416-535-8501 ext. 39674, liuyuhan0830@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vesicular Monoamine Transporter 2 Binding Potential (VAMT2 BPND) (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 11 Feb 2026.