Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-24 @ 4:09 PM
NCT ID:
NCT06086366
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06086366
Study Brief:
Protocol Section:
NCT06086366