Changes in the Blood-brain Barrier During Maintenance ECT in Formerly Depressed Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Permeability
研究概览
简要总结
The aim of the study is to examine the effect of electroconvulsive therapy (ECT) on the blood-brain barrier (BBB) in patients who had suffered from depression. We will study the BBB with dynamic contrast enhanced (DCE) MRI before and after treatment with a single ECT in patients currently undergoing ECT. The study is an observational (naturalistic) longitudinal study.
详细描述
Primary hypothesis
- The BBB permeability to Gadovist (measured as Ki) temporarily increases in the right and left hippocampus (HC) after a single ECT.
Secondary hypothesises 2. The volume of the right and left HC increases after a single ECT and the volume increase is positively correlated with the BBB permeability 3. A larger post-ECT increase in systolic blood pressure correlates with a larger increase in BBB permeability in the right and left HC. 4. A larger increase in serum S100-B compared to baseline values is correlated with increased BBB permeability in the right and left HC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •We will include patients (age 18-75) currently treated with a series of ECT or maintenance ECT referred to the treatment due to moderate to severe depression according to ICD-10.
排除标准
- •Schizophrenia
- •Psychotic symptoms
- •Any substance use (other than cigarette smoking and alcohol consumption within the recommendations of the Danish National Health Authority) within the last 3 months
- •Risk of suicide making transport or participation in the study hazardous
- •Claustrophobia or severe restlessness
- •Contraindications to DCE-MRI (e.g., metallic implants, increased body temperature, reduced kidney function (estimated Global Filtration Rate (eGFR) of <40 ml/min/1.73 m2), pregnancy)
- •Somatic illness potentially confounding results (e.g., any central nervous system diseases or cancers)
- •Lack of consent to being informed of potential medically important findings on MRI or blood tests
结局指标
主要结局
Permeability
时间窗: Permeability is measured before a single ECT and 0-8 hours after a single ECT
Change in permeability measured as Ki in the units of ml/100g/min in the right and left hippocampus
次要结局
未报告次要终点
研究者
Poul Videbech
Professor Poul Videbech
University of Copenhagen