Presynaptic Imaging in Major Depressive Episodes After COVID-19

Major Depressive Disorder Clinical Trial

— PCOV  

Official title:

Presynaptic Imaging in Major Depressive Episodes After COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086366
• Other study ID #: REB#201/2022
• Status: Recruiting
• Start date: August 22, 2023
• Est. completion date: September 10, 2025

Study information

• Verified date: October 2023
• Source: Centre for Addiction and Mental Health
• Contact: Karida Liu
• Phone: 416-535-8501
• Email: liuyuhan0830[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 10, 2025
• Est. primary completion date: September 10, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Long COVID
• Major Depressive Disorder
• Major Depressive Episode

Intervention

Other:
• [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

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 3 to 4 weeks after initiation of screening
Primary	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	within 3 to 4 weeks after initiation of screening