Presynaptic Imaging in Major Depressive Episodes After COVID-19
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorCentre for Addiction and Mental Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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/
Disqualifiers
Age 18 to 75.
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
Trial population
Recovered from mild to moderate COVID-19 respiratory symptoms with subsequent onset of COVID-DNP
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
[11C]DTBZ PET scan
Other interventionOne \[11C\]DTBZ scan for vesicular monoamine transporter 2 (VMAT2)
[18F]SDM8 PET scan
Other interventionOne \[18F\]SDM8 scan for synaptic vesicle glycoprotein 2A (SV2A)
MRI scan
Other interventionOne MRI scan
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: COVID-DNP3 interventions
Group B: Healthy Control3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
within 3 to 4 weeks after initiation of screening2
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
Time frame
within 3 to 4 weeks after initiation of screeningSponsors and contacts
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Source ClinicalTrials.gov