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胡晓月医师:请上传完整版伦理审批文件。 经颅磁刺激治疗老年抑郁症的增效研究及认知功能的影响
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注册号:

Registration number:

ChiCTR1900024445 

最近更新日期:

Date of Last Refreshed on:

2019-07-12 

注册时间:

Date of Registration:

2019-07-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

胡晓月医师:请上传完整版伦理审批文件。 经颅磁刺激治疗老年抑郁症的增效研究及认知功能的影响 

Public title:

A Comparative Study for the Therapeutic Effect and Cognitive Influence of Transcranial Magnetic Stimulation as an Augmentative Treatment Strategy to Treat Patients with Senile Depression 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

经颅磁刺激治疗老年抑郁症的增效研究及认知功能的影响 

Scientific title:

A Comparative Study for the Therapeutic Effect and Cognitive Influence of Transcranial Magnetic Stimulation as an Augmentative Treatment Strategy to Treat Patients with Senile 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:

胡晓月 

研究负责人:

马辛 

Applicant:

Hu Xiaoyue 

Study leader:

Ma Xin 

申请注册联系人电话:

Applicant telephone:

+86 18810611948 

研究负责人电话:

Study leader's telephone:

+86 13701364608 

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:

yue18810611948@163.com 

研究负责人电子邮件:

Study leader's E-mail:

maxinanding@vip.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:

北京市西城区德胜门外大街安康胡同5号 

研究负责人通讯地址:

北京市西城区德胜门外大街安康胡同5号 

Applicant address:

5 Ankang Lane, Deshengmenwai Anenue, Xicheng District, Beijing 

Study leader's address:

5 Ankang Lane, Deshengmenwai Anenue, Xicheng District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

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 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

(2019)科研第(40)号-201963FS-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:

2019-06-17 

伦理委员会联系人:

贾津京 

Contact Name of the ethic committee:

Jinjing Jia 

伦理委员会联系地址:

北京市西城区德胜门外大街安康胡同5号 

Contact Address of the ethic committee:

5 Ankang Lane, Deshengmenwai Anenue, Xicheng District, Beijing 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

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:

北京市西城区德胜门外大街安康胡同5号 

Primary sponsor's address:

5 Ankang Lane, Deshengmenwai Anenue, 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(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京安定医院

具体地址:

西城区德胜门外大街安康胡同5号

Institution
hospital:

Beijing Anding Hospital, Capital Medical University

Address:

5 Ankang Lane, Deshengmenwai Anenue, Xicheng District

经费或物资来源:

北京市保健科研课题京16号 

Source(s) of funding:

Beijing Health Research Project Jing 16 

研究疾病:

老年抑郁症 

Target disease:

Late-Life Depression 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

(1)评估rTMS联合抗抑郁药对老年抑郁症的起效时间、疗效、安全性。 (2)利用RBANS量表,评估rTMS对其认知功能的影响。 

Objectives of Study:

(1) Evaluate the onset time, efficacy, and safety of rTMS combined with antidepressants in geriatric depression. (2) The impact of rTMS on its cognitive function was assessed using the RBANS scale. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1)门诊或住院老年抑郁患者年龄≥60岁且≤75岁 ; 2)符合ICD-10抑郁发作或复发性抑郁障碍诊断标准; 3)汉密顿抑郁量表(HAMD)17项版本总分>17分; 4)右利手,既往未使用过rTMS治疗; 5)所有被试均为自愿参加, 并于入组研究前书面签署知情同意书。 

Inclusion criteria

(1) Outpatients or hospitalized elderly depressed patients aged 60 to 75 years; (2) Meets the diagnostic criteria for ICD-10 depressive episodes or recurrent depressive disorder; (3) The total score of the 17 versions of the Hamilton Depression Scale (HAMD) is >17 points; (4) Right hand, has not used rTMS treatment before; (5) All participants participated voluntarily and signed informed consent before the enrollment study. 

排除标准:

1)现患抑郁症外的其他精神疾病; 2)其他全身系统性疾病及脑部器质性病变所致抑郁状态; 3)既往有严重脑部外伤、癫痫发作疾病史; 4)严重的心血管系统、呼吸系统、免疫系统等全身性疾病史; 5)酒精、吗啡类药物滥用史; 6)不能配合完成rTMS治疗及影像学检查者; 7)体内有金属植入物及假牙、动脉夹、起搏器或金属固定物等; 8)近6个月行MECT治疗患者; 9)具有严重自杀观念患者; 10)MMSE阳性者;(文化程度:小学≤20分,初中及以上≤24分)。 

Exclusion criteria:

(1) Other mental illnesses other than depression; (2) Other systemic diseases and depression caused by organic brain diseases; (3) Have a history of severe brain trauma and seizures; (4) A serious history of systemic diseases such as the cardiovascular system, respiratory system, and immune system; (5) History of abuse of alcohol and morphine drugs. 

研究实施时间:

Study execute time:

From2019-06-17To 2020-06-16 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

experimental group

Sample size:

干预措施:

rTMS+SSRI类药物

干预措施代码:

Intervention:

rTMS + SSRI drugs

Intervention code:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

伪rTMS+SSRI类药物

干预措施代码:

Intervention:

False rTMS+SSRI drugs

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):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京安定医院 

单位级别:

三级甲等医院 

Institution
hospital:

Beijing Anding Hospital, Capital Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

汉密尔顿抑郁(17项)量表

指标类型:

主要指标 

Outcome:

HamiltonDepressionScale-17

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

神经心理状态评定量表

指标类型:

主要指标 

Outcome:

RBANS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 60 years
最大 Max age 75 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):

随机分组由非参与试验的人员通过计算机和Excel软件产生随机数字编码。

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

Non-participants decide a random number through the computer Excel software.

盲法:

双盲

Blinding:

Double blind.

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

试验完成后6个月内公开

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

within six months after the trial complete

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:

病例记录表

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

CRF ResMan

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-12
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