Presynaptic Imaging in Major Depressive Episodes After COVID-19
NCT ID: NCT06086366
Last Updated: 2023-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
90 participants
OBSERVATIONAL
2023-08-22
2025-09-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neuroinflammation in COVID-19 and Depression
NCT04854785
DPA-714 and FDG PET/MRI in Depression
NCT06565936
Neuroimaging Markers of Midlife Depression and Cognitive Behavioural Therapy (CBT)
NCT07091643
A Randomized Neuroimaging Trial of Psilocybin in Depression
NCT06072898
Brain Inflammation in Major Depressive Disorder Background
NCT01851356
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The main question\[s\] it aims to answer are:
1. The investigators will determine if VMAT2 binding potential (VMAT2 BPND) is reduced in ventral striatum and dorsal putamen in COVID-DNP.
2. The investigators will determine if SV2A total distribution volume (SV2A VT) is reduced in ventral striatum and dorsal putamen in COVID-DNP
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
COVID-DNP
Participants that have recovered from mild or moderate COVID-19 respiratory symptoms and have a new onset major depressive episode (MDE).
[11C]DTBZ PET scan
One \[11C\]DTBZ scan for vesicular monoamine transporter 2 (VMAT2)
[18F]SDM8 PET scan
One \[18F\]SDM8 scan for synaptic vesicle glycoprotein 2A (SV2A)
MRI scan
One MRI scan
Healthy Control
Participants in good physical health, age- and sex-matched to Group 1 and 2 participants.
[11C]DTBZ PET scan
One \[11C\]DTBZ scan for vesicular monoamine transporter 2 (VMAT2)
[18F]SDM8 PET scan
One \[18F\]SDM8 scan for synaptic vesicle glycoprotein 2A (SV2A)
MRI scan
One MRI scan
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
[11C]DTBZ PET scan
One \[11C\]DTBZ scan for vesicular monoamine transporter 2 (VMAT2)
[18F]SDM8 PET scan
One \[18F\]SDM8 scan for synaptic vesicle glycoprotein 2A (SV2A)
MRI scan
One MRI scan
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre for Addiction and Mental Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jeff Meyer
Scientist and Head, Neurochemical Imaging Program in Mood and Anxiety Disorders, Brain Health Imaging Centre, Campbell Family Mental Health Research Institute
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeffrey Meyer, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REB#201/2022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.