Does Electroconvulsive Therapy Cause Neuroinflammation? An [18F]FEPPA Positron Emission Tomography Study in Treatment Resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in translocator protein distribution volume (TSPO Vt) measured by [18F]FEPPA PET
研究概览
简要总结
The purpose of this study is to explore whether electroconvulsive therapy (ECT) accidentally leads to a side effect of brain inflammation. Patients with treatment resistant depression who are planning to take ECT will be subsequently approached to participate in the study.
详细描述
The first scan will take place before the first ECT session. The second scan will occur after a minimum of six ECT sessions (average 2.5 weeks). Secondary measures will include mood symptom severity, neurocognitive measures, peripheral inflammatory markers and TSPO genotype.
The hypothesis is that neuroinflammation will be increased by ECT.
There will be no alterations to standard care of depressed patients due to participation in the study.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stable physical health
- •diagnosis of non-psychotic, non-catatonic, major depressive disorder, either unipolar or bipolar and a non-response to at least three clinical trials at appropriate dose of antidepressant medication from at least three different pharmacological classes
- •at least a 17 on the17-item HDRS despite taking antidepressant treatment prior to ECT
- •have not received ECT within the last 12 weeks
排除标准
- •currently pregnant
- •current substance abuse or dependence
- •neurological or unstable medical illness
- •use of anti-inflammatory drugs within the past month
- •diazepam or other benzodiazepine use within the past month, except for lorazepam and clonazepam
结局指标
主要结局
Change in translocator protein distribution volume (TSPO Vt) measured by [18F]FEPPA PET
时间窗: Baseline scan and a second PET scan after an expected average time of 2.5 weeks of ECT treatment
Participants will have one \[18F\]FEPPA PET scan before they start ECT and a second PET scan on average after 2.5 weeks of ECT
次要结局
- 17-item Hamilton Depression Rating Scale (HDRS)(Baseline and after average 2.5 weeks of ECT treatment)
- Neurocognitive Battery(Baseline and after average 2.5 to 5 weeks of ECT treatment)
- Peripheral Inflammatory Markers(Baseline and after average 2.5 to 5 weeks of ECT treatment)
研究者
Jeff Meyer
Program Head, Neurochemical Imaging for Mood Disorders
Centre for Addiction and Mental Health