Study by 1H NMR of the Variations of the Metabolome During the Course of Electroconvulsive Therapy in Patients With Major Depressive Episode
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Value the metabolic profile difference between the baseline and before the 6th session of ECT by blood metabolomics through 1HNMR
研究概览
简要总结
Investigators will measure the variation of blood Metabolome through 1H NMR at several time points during the course of electroconvulsivetherapy in patients with a major depressive episode. Patients with a major depressive disorder or a bipolar disorder and a current major depressive episode will be included in this study. Investigators hypothesized that Metabolome could be a source to predict response during ECT and to help understanding underlying biological mechanisms.
详细描述
Biological signatures of blood metabolome will be measure before and after the first session of electroconvulsivetherapy, and during the course, before the 6th, 12th and the last sessions. Proton Nuclear Magnetic Resonance spectroscopy will be used to measure metabolites in blood sample. In parallel, at each time point, depression severity (MADRS and BDI), Perceived severity (CGI), global functioning (EGF), convulsive characteristics and cognitive tolerance (MOCA) will be measure, at each time point.
The aim of this study is to determine whether 1HNMR could help to understanding metabolic ways and predict response to ECT in patients with a current Major Depressive Episode (MDE) in Major Depressive Disorder (MDD) and in Bipolar Disorder (BD).
To date, scientific community knows that ECT is a safety and efficacy treatment in MDE particularly resistant or severe, but scientific community knows little about its mechanism of action.
The investigators hypothesize that 1HNMR could help to go further.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major depressive episode according to DSM-5 criteria
- •Diagnosis of major depressive disorder or bipolar disorder
- •MADRS score >22
- •having given written, free and informed consent
- •without protective measures
- •resistance criterion defined as failure of 2 antidepressants at an effective dose for a minimum of 6 weeks
- •current major depressive episode according to DSM-5 criteria with indication of treatment by ECT cure
排除标准
- •Cannot be included in the study, people:
- •whose consent is not admissible or who refuse to participate in the study
- •deprived of liberty by judicial or administrative decision
- •For which there is a particular risk contraindicating the cure of ECT
- •Suffering from schizophrenia spectrum disorders or persistent delusional disorder as described by DSM-5 Criterion D for Major Depressive Disorder
- •suffering from neurological disorders (such as patients suffering from multiple sclerosis, epilepsy, encephalitis, etc.) and/or neurodegenerative disorders (such as Parkinson's disease, Alzheimer's disease or related diseases, etc.) as described by criterion C of the major depressive disorder listed in the DSM-5
- •suffering from an acute or chronic systemic inflammatory disease requiring specific treatment with immunomodulators or suppressors. As well as any recurrent inflammatory disease requiring specific management, and which may lead to a differential diagnosis of the characterized depressive episode as described by criterion C listed in the DSM-5
结局指标
主要结局
Value the metabolic profile difference between the baseline and before the 6th session of ECT by blood metabolomics through 1HNMR
时间窗: up to 3 weeks
identify variations in the metabolome by measuring the metabolome in the blood of patients treated for depressive episodes or bipolar disorder by identifying the metabolic profiles associated with the medical response to ECT between the Baseline and before the sixth ECT session.
次要结局
- Measure the biological effect of one ECT session on the blood metabolome(through first ECT session, an average of 1 week)
- Compare the biological effect measured between the baseline and before the 1st, 6th and 12th session of ECT(through study completion, up to 6 weeks)
- Measure the variations of the metabolic signature according to the clinical response during the ECT treatment(up to 10 weeks)
- Look for a metabolic signature to discriminate between responder and non-responder patients before the 6 ECT sessions (i.e. the day of the 6th)(through the sixth session, up 3 weeks)