Longitudinal Effect of Electroconvulsive Therapy on Schizophrenia and Bipolar Disorder: a MRI Study
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Changes of Positive And Negative Syndrome Scale(PANSS)for Schizophrenia;
研究概览
简要总结
For more severe and treatment-resistant cases in schizophrenia and bipolar disorder, electroconvulsive therapy (ECT) is often very effective. The purpose of this study is to investigate the brain structure and function changes after ECT treatment. The neuroimaging marker which may predict the outcome of ECT is also studied in this research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •International classification of diseases (ICD) diagnosis of Schizophrenia and bipolar disorder;
- •Ages 15-70
- •All participants are ethnic Han
- •Not received ECT treatment before
- •PANSS ≥ 60 for schizophrenia subjects
- •The patient's written informed consent can be obtained. If the patient is incapacitated during the onset period, the written informed consent of the legal guardian is required.
排除标准
- •Those with mental retardation, generalized developmental disorders,delirium, dementia, memory impairment or cognitive impairment that meet the diagnostic criteria of ICD-10;
- •Patients with cognitive impairment, such as Parkinson's, multiple sclerosis, stroke, and patients who meet the diagnostic criteria for ICD-10 alcohol dependence (except nicotine dependence);
- •The course of the disease is very short (fast phase inversion), such as 4 or more different mood abnormalities (depression, mild mania, mania, mental illness) in one year;
- •With severe unstable physical diseases; diagnosed diabetes, thyroid disease, hypertension, heart disease, etc.;
- •Narrow angle glaucoma;
- •With a history of epilepsy, except those with febrile seizures;
- •Have or have had drug-induced malignant syndrome and severe tardive dyskinesia;
- •With serious suicide attempts;
- •Cannot take medication as directed by their doctors, or who do not have guardians;
- •Pregnant or lactating women, or those who plan to become pregnant;
研究组 & 干预措施
ECT treatment
Patients received bilateral temporal modified ECT (MECT) for three weeks,four times a week. Meanwhile, they also had antipsychotic drugs.
干预措施: ECT treatment (Device)
Drug treatment
Patients only received antipsychotic drugs during observation period.
干预措施: Drug treatment (Drug)
结局指标
主要结局
Changes of Positive And Negative Syndrome Scale(PANSS)for Schizophrenia;
时间窗: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.
Change of Bech-Rafaelsen Mania Rating Scale (BRMS) for Bipolar disorder
时间窗: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.
Change of Hamilton Anxiety Scale (HAMA) for Bipolar disorder
时间窗: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.
Change of Hamilton depression scale (HAMD) for Bipolar disorder
时间窗: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.
次要结局
- Changes of brain gray matter, white matter and functional based on MRI data analysis(2 time points:baseline, the end of the three-week treatment])
- Change of Mini-Mental State Examination(3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment)