Recruiting

Observational Study

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT06086366

Conditions

Long COVID

Major Depressive Disorder

Major Depressive Episode

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

[11C]DTBZ PET scan

[18F]SDM8 PET scan

MRI scan

Study Details

Brief 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.

Conditions

Long COVID

Major Depressive Disorder

Major Depressive Episode

Study ID

NCT06086366

Start date

Aug 22, 2023

Status verified date

Feb, 2026

Completion date

Sep 10, 2028

Anticipated

Primary completion date

Sep 10, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

COVID-DNP

Participants that have recovered from mild or moderate COVID-19 respiratory symptoms and have a new onset major depressive episode (MDE).

Healthy Control

Participants in good physical health, age- and sex-matched to Group 1 and 2 participants.

Interventions

[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

Primary outcome measure

  • Vesicular Monoamine Transporter 2 Binding Potential (VAMT2 BPND) [ Time Frame: within 3 to 4 weeks after initiation of screening ]
  • Synaptic Vesicle Glycoprotein 2A Total Distribution Volume (SV2A VT) [ Time Frame: within 3 to 4 weeks after initiation of screening ]

Central Contacts and Locations

Central contacts

Karida Liu

416-535-8501liuyuhan0830@gmail.com

Jeffrey Meyer

416-535-8501jeffrey.meyer@utoronto.ca

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada

Contacts

Yuhan Liu

(416) 535-8501 ext. 39674yuhan.liu@camh.ca

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

  • PET
  • Long COVID
  • Major Depressive Disorder
  • Major Depressive Episode
  • Anhedonia
  • Dopamine Neuron Loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-02-11.