The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy: A Randomized Clinical Trial And Its Standard Technology Promotion Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Scale(HAMD) Scores
研究概览
简要总结
- To determine the influencing factors of modified electroconvulsive therapy (MECT);
- To determine the influencing factors and reversibility of the cognitive impairment caused by MECT;
- To determine the duration of efficacy of MECT and its affecting factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Aged over 18 years (when informed consent was got), male or female
- •Meet International Classification of Diseases-10(ICD-10) diagnostic criteria for depression
- •Scored 18 or above on the HAM-D Scale which included 17 items
- •Clinical Global Impression(CGI)-severity score ≥ 4
- •Provided written informed consent
排除标准
- •Any depressive disorders not due to major depressive disorder
- •Meet other diagnosis criteria in Diagnostic and Statistical Manual of Mental Disorders-IV-Test Revision(DSM-IV-TR) Axis I
- •With a history of acute or chronic renal failure, liver cirrhosis or active hepatopathy
- •With clinically significant abnormal results of laboratory test, which are considered to have impact on treatment efficacy and the safety of participants
- •With a history of severe or unstable physical disease including nervous system disease and myocardial infarction
- •Undergoing alcoholism or alcohol (or substance) abuse during 30 days or 6 months before the trial
- •With no response to previous ECT treatment
- •Received transcranial magnetic stimulation treatment in the last 6 months
- •Allergic to propofol, etomidate and succinylcholine chloride
- •During pregnancy or lactation
- •With a history of stroke in the last month
- •Enrolled in any other clinical trial 30 days prior to the baseline
研究组 & 干预措施
Bilateral temporal and propofol
During the MECT treatment, electrodes are placed at bilateral temporal, with propofol 2mg/kg to Induce anesthesia.
干预措施: Propofol (Drug)
Bilateral temporal and propofol
During the MECT treatment, electrodes are placed at bilateral temporal, with propofol 2mg/kg to Induce anesthesia.
干预措施: Bilateral temporal MECT (Device)
Bilateral temporal and etomidate
During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia.
干预措施: Etomidate (Drug)
Bilateral temporal and etomidate
During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia.
干预措施: Bilateral temporal MECT (Device)
The right temporal and propofol
During the MECT treatment, electrodes are placed at the right temporal, with propofol 2mg/kg to Induce anesthesia.
干预措施: Propofol (Drug)
The right temporal and propofol
During the MECT treatment, electrodes are placed at the right temporal, with propofol 2mg/kg to Induce anesthesia.
干预措施: The right temporal MECT (Device)
The right temporal and etomidate
During the MECT treatment, electrodes are placed at the right temporal, with etomidate 0.3mg/kg to Induce anesthesia.
干预措施: Etomidate (Drug)
The right temporal and etomidate
During the MECT treatment, electrodes are placed at the right temporal, with etomidate 0.3mg/kg to Induce anesthesia.
干预措施: The right temporal MECT (Device)
Bilateral frontal and propofol
During the MECT treatment, electrodes are placed at bilateral frontal, with propofol 2mg/kg to Induce anesthesia.
干预措施: Propofol (Drug)
Bilateral frontal and propofol
During the MECT treatment, electrodes are placed at bilateral frontal, with propofol 2mg/kg to Induce anesthesia.
干预措施: Bilateral frontal MECT (Device)
Bilateral frontal and etomidate
During the MECT treatment, electrodes are placed at bilateral frontal, with etomidate 0.3mg/kg to Induce anesthesia.
干预措施: Etomidate (Drug)
Bilateral frontal and etomidate
During the MECT treatment, electrodes are placed at bilateral frontal, with etomidate 0.3mg/kg to Induce anesthesia.
干预措施: Bilateral frontal MECT (Device)
Standard-therapy Group
During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia.
干预措施: Etomidate (Drug)
Standard-therapy Group
During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia.
干预措施: Bilateral temporal MECT (Device)
结局指标
主要结局
Change in Hamilton Depression Scale(HAMD) Scores
时间窗: Change from Baseline in Hamilton Depression Scale scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
Change in Wechsler Memory Scale (WMS) Scores as a Measure of Safety
时间窗: Change from Baseline in Wechsler Memory Scale (WMS) Scores at 42d and 180d after the last MECT session
次要结局
- Young Manic Rating Scale(MMSE) as a Measure for Evaluation of Mania State(42d and 180d after the last MECT session)
- Resting-state/Task-state functional magnetic resonance imaging (fMRI)(Change form Baseline in Resting-state/Task-state fMRI Imging Results at 42d and 180d after the last MECT session)
- Change in Hamilton Anxiety Scale(HAMA) Scores(Change from Baseline in Hamilton Anxiety Scale Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session)
- Change in Clinical Global Impression-severity of illness(CGI-SI) Scores as a Measure of Efficacy(Change from Baseline in CGI-SI Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session)
- Change in Wisconsin Card Sorting Test(WCST) Scores as a Measure of Safety(Change from Baseline in Wisconsin Card Sorting Test(WCST) Scores at 42d and 180d after the last MECT session)
- Change in P300/P50 Event-Related Potentials(ERP)(Change from Baseline in P300/P50 Event-Related Potentials(ERP) at 42d and 180d after after the last MECT session)