ChiCTR2600116373 版本V1.0 版本创建时间2026/01/08 17:02:33 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600116373 

最近更新日期：

Date of Last Refreshed on：

2026-01-08 17:02:15 

注册时间：

Date of Registration：

2026-01-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

磁惊厥治疗与无抽搐电痉挛治疗对抑郁症患者皮层兴奋性及认知功能影响的对照研究

Public title：

A Controlled Study on the Effects of Magnetic Seizure Therapy versus Electroconvulsive Therapy on Cortical Excitability and Cognitive Function in Patients with Depression

注册题目简写：

English Acronym：

研究课题的正式科学名称：

磁惊厥治疗与无抽搐电痉挛治疗对抑郁症患者皮层兴奋性及认知功能影响的对照研究

Scientific title：

A Controlled Study on the Effects of Magnetic Seizure Therapy versus Electroconvulsive Therapy on Cortical Excitability and Cognitive Function in Patients with Depression

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

赵莹莹 

研究负责人：

赵莹莹 

Applicant：

Yingying Zhao 

Study leader：

Yingying Zhao 

申请注册联系人电话：

Applicant telephone：

+86 188 1008 8586

研究负责人电话：

Study leader's telephone：

+86 188 1008 8586

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

zhaoyingying1031@163.com

研究负责人电子邮件：

Study leader's E-mail：

zhaoyingying1031@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

北京市西城区安康胡同5号

研究负责人通讯地址：

北京市西城区安康胡同5号

Applicant address：

No. 5, Ankang Hutong, Xicheng District, Beijing

Study leader's address：

No. 5, Ankang Hutong, Xicheng District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

100088

研究负责人邮政编码：

Study leader's postcode：

100088

申请人所在单位：

首都医科大学附属北京安定医院

Applicant's institution：

Beijing Anding Hospital, Capital Medical University

研究负责人所在单位：

首都医科大学附属北京安定医院

Affiliation of the Leader：

Beijing Anding Hospital, Capital Medical University,

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

(2025)科研第(208)号-2025260FS-2

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

首都医科大学附属北京安定医院伦理委员会

Name of the ethic committee：

Ethics Committee of Beijing Anding Hospital, Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-06-05 00:00:00

伦理委员会联系人：

贾京津

Contact Name of the ethic committee：

Jingjin Jia

伦理委员会联系地址：

北京市西城区安康胡同5号

Contact Address of the ethic committee：

No. 5, Ankang Hutong, Xicheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 5834 0320

伦理委员会联系人邮箱：

Contact email of the ethic committee：

anding_lunli@sina.com

研究实施负责（组长）单位：

首都医科大学附属北京安定医院

Primary sponsor：

Beijing Anding Hospital, Capital Medical University

研究实施负责（组长）单位地址：

北京市西城区安康胡同5号

Primary sponsor's address：

No. 5, Ankang Hutong, Xicheng District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京市

市(区县)：

北京市

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

首都医科大学附属北京安定医院

具体地址：

北京市西城区安康胡同5号

Institution
hospital：

Beijing Anding Hospital, Capital Medical University

Address：

No. 5, Ankang Hutong, Xicheng District, Beijing

经费或物资来源：

研究型病房卓越临床研究计划项目

Source(s) of funding：

Beijing Research Ward Excellence Program

Target disease：

Major Depressive Disorder

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

比较MECT及MST治疗抑郁症的疗效及安全性，对照MECT及MST治疗前后及两组之间在疗效、认知功能尤其是记忆力方面的差异。 探讨MECT及MST治疗抑郁症在疗效、认知及自杀意念改善方面的机制并探讨相关的生物标记物，包括神经电生理及脑影像学指标。  

Objectives of Study：

Study Aim 1:To conduct a comparative evaluation of the therapeutic efficacy and safety profiles of Modified Electroconvulsive Therapy (MECT) and Magnetic Seizure Therapy (MST) in patients with depression. This includes a head-to-head comparison of the two interventions, as well as within-group analyses of pre- and post-treatment changes, with a particular focus on differential impacts on clinical efficacy and cognitive functions, especially memory. Study Aim 2: To explore the neurobiological mechanisms mediating the effects of MECT and MST on clinical response, cognitive alterations, and amelioration of suicidal ideation in depression. This aim seeks to identify and evaluate potential biomarkers associated with treatment response, utilizing modalities such as neuroelectrophysiology and brain imaging.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

抑郁症患者入组标准 1.符合DSM-V重性抑郁发作诊断标准； 2.HAMD-17评分＞17分； 3.年龄18-60岁）； 4.实验室检查（血常规、生化）及心电图检查无异常； 5.获得患者本人或监护人或法定代理人的书面知情同意书。 健康对照组入组标准： 1.年龄18-65岁（包括18岁和65岁），性别不限； 2.小学以上文化程度，能理解研究内容； 3.既往体健，无心血管、呼吸、消化、肾脏、内分泌、血液等系统躯体疾病； 4.既往无精神障碍病史； 5.理解并自愿参加本研究，本人签署知情同意书。

Inclusion criteria

Inclution Criteria for depression patients: 1. Meet the diagnostic criteria for a Major Depressive Episode according to DSM-5. 2. Score > 17 on the 17-item Hamilton Depression Rating Scale (HAMD-17). 3. Aged between 18 and 60 years. 4. No abnormalities in laboratory tests (complete blood count, biochemistry) or electrocardiogram (ECG). 5. Provide written informed consent from the patient themselves, their guardian, or legal representative. Inclusion Criteria for the Healthy Control Group: 1. Age between 18 and 65 years (inclusive of 18 and 65), regardless of gender; 2. Education level above primary school, with the ability to understand the research content; 3. Generally healthy in the past, with no history of somatic diseases in the cardiovascular, respiratory, digestive, renal, endocrine, hematological, or other systems; 4. No history of mental disorders; 5. Understanding and voluntarily participating in this study, with signed informed consent provided by the participant.

排除标准：

抑郁症患者排除标准 1.排除抑郁症以外其它符合DSM-V诊断的精神疾病； 2.排除心电图检查或实验室结果有明显临床意义异常者，因可能影响疗效及对安全性的评价； 3.排除合并可能干扰研究或增加患者参与风险的严重心、肝、肾、眼、神经系统、内分泌系统及血液系统疾病，排除癫痫、恶性肿瘤、颅脑外伤者； 4.排除6个月内伴有物质依赖及滥用的患者； 5.排除服用丙戊酸盐的患者（允许使用苯二氮卓类催眠药物）； 6.排除入组前6个月内进行过MECT治疗的患者； 7.排除妊娠、哺乳期妇女或计划妊娠者； 8.排除颅内金属物体载体和/或心脏起搏器载体，以防止TMS的潜在不良影响。 健康对照组排除标准： 1.现患有精神类疾病； 2.意识障碍史，精神分裂症、双相情感障碍、抑郁障碍或人格改变等精神疾病史； 3.家族遗传性疾病史； 4.严重躯体疾病，例如内分泌系统疾病及心脑血管类疾病者； 5.酒精/药物依赖史； 6.妊娠期、哺乳期女性。

Exclusion criteria：

Exclusion Criteria for depression patients: 1. Exclusion of other psychiatric disorders meeting DSM-5 diagnostic criteria besides depression. 2. Exclusion of individuals with clinically significant abnormalities in electrocardiogram (ECG) or laboratory test results, as these may affect efficacy assessment or safety evaluation. 3. Exclusion of patients with severe concurrent cardiac, hepatic, renal, ophthalmic, neurological, endocrine, or hematological diseases that may interfere with the study or increase participation risks, as well as patients with epilepsy, malignant tumors, or traumatic brain injury. 4. Exclusion of patients with substance dependence or abuse within the past 6 months. 5. Exclusion of patients taking valproate (benzodiazepine hypnotics are permitted). 6. Exclusion of patients who have undergone Modified Electroconvulsive Therapy (MECT) within the past 6 months. 7. Exclusion of pregnant or breastfeeding women, or those planning pregnancy. 8. Exclusion of individuals with intracranial metal implants and/or cardiac pacemakers to prevent potential adverse effects of Transcranial Magnetic Stimulation (TMS). Exclusion Criteria for the Healthy Control Group: 1. Currently suffering from mental illnesses; 2. History of impaired consciousness, schizophrenia, bipolar disorder, depressive disorders, personality changes, or other mental disorders; 3. Family history of hereditary diseases; 4. Severe somatic diseases, such as endocrine system disorders or cardiovascular and cerebrovascular diseases; 5. History of alcohol/drug dependence; 6. Women who are pregnant or breastfeeding.

研究实施时间：

Study execute time：

从 From 2024-11-01 00:00:00至 To 2027-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-08 00:00:00 至 To 2027-09-30 00:00:00  

干预措施：

Interventions：

组别：

磁惊厥治疗组

样本量：

32

Group：

Magnetic Seizure Therapy Group

Sample size：

干预措施：

常规药物治疗联合磁惊厥治疗

干预措施代码：

Intervention：

Pharmacotherapy Combined with Magnetic Seizure Therapy

Intervention code：

组别：

电抽搐治疗组

样本量：

32

Group：

MECT group

Sample size：

干预措施：

常规药物治疗联合电抽搐治疗

干预措施代码：

Intervention：

Pharmacotherapy Combined with MECT

Intervention code：

组别：

健康对照组

样本量：

32

Group：

health control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

none

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

 Beijing 

Country：

China 

Province：

Beijing 

City：

Beijing 

单位(医院)：

首都医科大学附属北京安定医院 

单位级别：

三级 

Institution
hospital：

Beijing Anding Hospital, Capital Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

MST/MECT治疗结束后MCCB总分相对于基线变化

指标类型：

主要指标

Outcome：

Change in total MCCB score from baseline after completion of MST/MECT treatment.

Type：

Primary indicator

测量时间点：

基线，治疗结束后4天内

测量方法：

MCCB量表

Measure time point of outcome：

Baseline,Within 4 days after completion of MST/MECT treatment.

Measure method：

MATRICS Consensus Cognitive Battery

指标中文名：

电生理指标-皮层兴奋性及神经可塑性指标

指标类型：

次要指标

Outcome：

Electrophysiological Indices - Cortical Excitability and Neuroplasticity

Type：

Secondary indicator

测量时间点：

基线及急性治疗期后4天内

测量方法：

静息态脑电及TMS-EEG

Measure time point of outcome：

Baseline ,Within 4 days after acute treatment

Measure method：

Resting-state EEG and TMS-EEG Assessment

指标中文名：

脑影像指标

指标类型：

次要指标

Outcome：

Neuroimaging Indices

Type：

Secondary indicator

测量时间点：

基线及急性治疗期后4天内

测量方法：

核磁共振MRI

Measure time point of outcome：

Baseline,Within 4 days after completion of MST/MECT treatment.

Measure method：

MRI

指标中文名：

HAMD-17各维度分总分较基线变化

指标类型：

主要指标

Outcome：

Changes from baseline in the total scores of HAMD-17

Type：

Primary indicator

测量时间点：

基线，急性治疗期，治疗结束后，治疗结束后2周

测量方法：

HAMD-17量表

Measure time point of outcome：

Baseline, Acute Treatment Phase, End of Treatment, and 2 Weeks Post-treatment

Measure method：

17-item Hamilton Depression Rating Scale

指标中文名：

HAMA各维度分总分较基线变化

指标类型：

主要指标

Outcome：

Changes from baseline in the total scores of HAMA

Type：

Primary indicator

测量时间点：

基线，急性治疗期，治疗结束后，治疗结束后2周

测量方法：

HAMA量表

Measure time point of outcome：

Baseline, Acute Treatment Phase, End of Treatment, and 2 Weeks Post-treatment

Measure method：

Hamilton Anxiety Rating Scale

指标中文名：

CGI各维度分总分较基线变化

指标类型：

主要指标

Outcome：

Changes from baseline in the total scores of CGI

Type：

Primary indicator

测量时间点：

基线，急性治疗期，治疗结束后，治疗结束后2周

测量方法：

CGI量表

Measure time point of outcome：

Baseline, Acute Treatment Phase, End of Treatment, and 2 Weeks Post-treatment

Measure method：

Clinical Global Impression scale

指标中文名：

MCCB各维度分总分较基线变化

指标类型：

主要指标

Outcome：

changes from baseline in all domain scores of the MCCB

Type：

Primary indicator

测量时间点：

基线，急性治疗期，治疗结束后，治疗结束后2周

测量方法：

MCCB量表

Measure time point of outcome：

Baseline, Acute Treatment Phase, End of Treatment, and 2 Weeks Post-treatment

Measure method：

MATRICS Consensus Cognitive Battery

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

none

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 60 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

随机数字表法，由统计人员使用Excel的 RAND() 函数产生随机数列

Randomization Procedure (please state who generates the random number sequence and by what method)：

Statistical personnel used Excel's RAND() function to generate a random number sequence.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

单盲，对受试者设盲隐藏分组，对研究者不设盲，对研究评分员隐藏分组

Blinding：

Single-blind, with subjects blinded to group allocation, researchers unblinded, and research evaluators blinded to group allocation.

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

none

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

量表评估选择纸质表格，结果电子表格记录，双录入，进行数据核查和管理，所有研究者经过一致性培训，双录入核查，数据存档，病例报告表在按要求完成数据录入和核查后，按编号的顺序归档保存，并填有检索目录等，以备查考。电子数据文件包括数据库、检查程序、分析程序、分析结果、编码本和说明文件等，应分类保存，并有多个备份保存于不同磁盘或记录介质上，妥善保存，防止损坏。所有原始档案应按相应规定内的期限保存。临床研究过程中进行质量控制。对研究人员进行量表评估的一致性培训，在影像学数据采集及TMS-EEG数据采集过程中进行质控。 病例报告表在按要求完成数据录入和核查后，按编号的顺序归档保存，并填有检索目录，以备查考。电子数据文件包括数据库、检查程序、分析程序、分析结果、编码本和说明文件等，分类保存，并有多个备份保存于不同磁盘或记录介质上，妥善保存，防止损坏。所有原始档案应按相应规定内的期限保存。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

For scale assessments, paper forms were selected, and the results were recorded in electronic spreadsheets with double data entry. Data verification and management were conducted, and all researchers received consistency training. After double-entry verification, data were archived. Case report forms were filed in sequential order by number, along with retrieval catalogs, for future reference upon completion of data entry and verification as required. Electronic data files, including databases, inspection procedures, analysis programs, analysis results, codebooks, and documentation, were categorized and stored with multiple backups on different disks or recording media to ensure proper preservation and prevent damage. All original records were retained for the duration specified by relevant regulations. Quality control was implemented throughout the clinical research process. Researchers underwent consistency training for scale assessments, and quality control measures were applied during the acquisition of imaging data and TMS-EEG data.Upon completion of required data entry and verification, case report forms were archived in sequential order by number, accompanied by retrieval catalogs for reference. Electronic data files, including databases, inspection procedures, analysis programs, analysis results, codebooks, and documentation, were categorized and stored with multiple backups on different disks or recording media to ensure proper preservation and prevent damage. All original records were retained in accordance with the retention period specified by relevant regulations.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-01-08 17:02:15