Presynaptic Imaging in Major Depressive Episodes After COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Synaptic Vesicle Glycoprotein 2A Total Distribution Volume (SV2A VT)
研究概览
简要总结
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.
详细描述
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:
- The investigators will determine if VMAT2 binding potential (VMAT2 BPND) is reduced in ventral striatum and dorsal putamen in COVID-DNP.
- The investigators will determine if SV2A total distribution volume (SV2A VT) is reduced in ventral striatum and dorsal putamen in COVID-DNP
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •New onset MDE within 3 months after mild or moderate COVID-19, with MDE verified by the research version SCID for DSM
- •See "Positive COVID-19 diagnosis" listed after inclusion/
排除标准
- •for a description of how this is determined.
- •Age 18 to
- •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
研究组 & 干预措施
COVID-DNP
Participants that have recovered from mild or moderate COVID-19 respiratory symptoms and have a new onset major depressive episode (MDE).
干预措施: [11C]DTBZ PET scan (Other)
COVID-DNP
Participants that have recovered from mild or moderate COVID-19 respiratory symptoms and have a new onset major depressive episode (MDE).
干预措施: [18F]SDM8 PET scan (Other)
COVID-DNP
Participants that have recovered from mild or moderate COVID-19 respiratory symptoms and have a new onset major depressive episode (MDE).
干预措施: MRI scan (Other)
Healthy Control
Participants in good physical health, age- and sex-matched to Group 1 and 2 participants.
干预措施: [11C]DTBZ PET scan (Other)
Healthy Control
Participants in good physical health, age- and sex-matched to Group 1 and 2 participants.
干预措施: [18F]SDM8 PET scan (Other)
Healthy Control
Participants in good physical health, age- and sex-matched to Group 1 and 2 participants.
干预措施: MRI scan (Other)
结局指标
主要结局
Synaptic Vesicle Glycoprotein 2A Total Distribution Volume (SV2A VT)
时间窗: within 3 to 4 weeks after initiation of screening
The investigators will determine if SV2A VT is changed in ventral striatum and dorsal putamen in COVID-DNP
Vesicular Monoamine Transporter 2 Binding Potential (VAMT2 BPND)
时间窗: within 3 to 4 weeks after initiation of screening
The investigators will determine if VMAT2 BPND is changed in ventral striatum and dorsal putamen in COVID-DNP.
次要结局
未报告次要终点
研究者
Jeff Meyer
Scientist and Head, Neurochemical Imaging Program in Mood and Anxiety Disorders, Brain Health Imaging Centre, Campbell Family Mental Health Research Institute
Centre for Addiction and Mental Health