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Идёт набор NCT06086366

Presynaptic Imaging in Major Depressive Episodes After COVID-19

— Наблюдательное Long COVID Major Depressive Disorder Major Depressive Episode

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: [11C]DTBZ PET scan, [18F]SDM8 PET scan, MRI scan.
Кому может быть актуально
Состояния в реестре: Long COVID, Major Depressive Disorder, Major Depressive Episode. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Обзор

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.

Подробное описание

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

Вмешательства

  • Другое [11C]DTBZ PET scan
    One \[11C\]DTBZ scan for vesicular monoamine transporter 2 (VMAT2)
  • Другое [18F]SDM8 PET scan
    One \[18F\]SDM8 scan for synaptic vesicle glycoprotein 2A (SV2A)
  • Другое MRI scan
    One MRI scan

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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).

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Канада · 1 центр
  • Centre for Addiction and Mental Health — Toronto

Идентификаторы

NCT: NCT06086366 · REB#201/2022

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗