针刺抗抑郁效应机制的脑网络研究

注册号:

Registration number:

AMCTR-IPR-19000307 

注册号获得时间:

Date of releasing the registration number:

2019/10/23 21:37:56 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺抗抑郁效应机制的脑网络研究 

Public title:

Study on Brain Network of Antidepressant Effect Mechanism with Acupuncture 

研究课题的正式科学名称:

针刺抗抑郁效应机制的脑网络研究 

Scientific title:

Study on Brain Network of Antidepressant Effect Mechanism with Acupuncture 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

张方圆 

研究负责人:

吴倩 

Applicant:

Zhang Fangyuan 

Study leader:

Wu Qian 

申请注册联系人电话:

Applicant telephone:

+86 13153141502 

研究负责人电话:

Study leader's telephone:

+86 13580323354 

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:

791305416@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

wuqian@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:

广东省广州市白云区三元里街道机场路12号 

研究负责人通讯地址:

广东省广州市越秀区大德路111号 

Applicant address:

12 Airport Road, Sanyuanli Street, Baiyun District, Guangzhou, Guangdong, China 

Study leader's address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China 

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:

广州中医药大学 

Applicant's institution:

Guangzhou University of Traditional Chinese Medicine 

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:

201803060054 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

中山大学心理学系保护人类被试伦理审查委员会 

Name of the ethic committee:

Ethics Review Committee for the Protection of Human Subjects, Department of Psychology, Sun Yat-Sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-03-06 

研究实施负责(组长)单位:

广东省中医院 

Primary sponsor:

Guangdong Province Traditional Chinese Medical Hospital 

研究实施负责(组长)单位地址:

广州市越秀区大德路111号 

Primary sponsor's address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学

具体地址:

新港西路135号

Institution
hospital:

Sun Yat-Sen University

Address:

135 Xingang Road West

国家:

中国

省(直辖市):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广东省中医院

具体地址:

越秀区大德路111号

Institution
hospital:

Guangdong Province Traditional Chinese Medical Hospital

Address:

111 Dade Road, Yuexiu District

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

抑郁症 

Target disease:

Depression 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

预实验 

Study phase:

Polit 

研究目的:

运用多学科研究方法与手段,验证轻中度抑郁障碍患者脑功能网络的拓扑属性特异性存在,探讨抑郁症患者脑网络的病理模型。并揭示针刺疗效机制的神经学基础,寻求与临床评价相结合的针刺疗效机制的客观神经指标 

Objectives of Study:

By using multidisciplinary research methods, the specificity topological properties of brain functional network in patients with mild and moderate depression will be verified, and the pathological model of brain network in patients with depression will be discussed. It also hopes to reveal the neurological basis of acupuncture curative effect mechanism and seek objective neurological indexes of acupuncture curative effect mechanism combined with clinical evaluation 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1. 符合美国精神医学协会DSM-5关于其它躯体情况所致的抑郁障碍发作诊断标准,且程度符合国际疾病分类编码表(ICD-10)中轻度抑郁(F32.0)或中度抑郁(F32.1)、或者HAMD-17评分<23分,≥8分者。 2. 初诊时为首次发生抑郁障碍; 3. 3个月内未接受激素替代疗法或抗抑郁药物治疗的患者; 4. 年龄≥18岁至≤40岁; 5. 签署知情同意书,自愿参加本项研究者 

Inclusion criteria

1. Participants who meet the diagnostic criteria of Depressive Disorder Due to Another Medical Condition according to DSM – 5 from the American psychiatric association,and the level of depression conforms to moderate to mild depression (F32.0) or moderate depression (F32.1) according to the International Classification of Diseases Coding Table (ICD-10) or whose HAMD-17 score 8-22; 2. Participants was diagnosed with a first appearance depressive disorder; 3. Participants who have not received hormone replacement therapy or anti-depression medication within 3 months; 4. Participants aged 18 to 40 years; 

排除标准:

1. Beck自杀意念量表(SSI)第4、5项任何一项答案不为“没有”; 2. 经SCL-90评分中抑郁因子项未能排除自杀倾向者(>26分); 3. 本研究开始前4周内曾参加过其他临床试验者; 4. 有其他系统的严重疾病需要治疗者; 5. 脑部疾病,判定能力异常(成人韦氏智力量表小于90分者); 6. 有妊娠意愿或正处于妊娠或哺乳期者; 7. 试验前2周曾服用使用抗抑郁、抗焦虑药物治疗者。 8. 安装心脏起搏器或人工关节者 

Exclusion criteria:

1. Item 4 or 5 of Beck Suicide Ideation Scale (SSI) is not answered "No"; 2. The depression factors in SCL-90 score failed to exclude the suicidal tendency (>26); 3. Participants had participated in other clinical trials within 4 weeks before the start of this study; 4. Participants who had severe diseases of other systems require treatment; 5. Participants had brain diseases and judgment ability was abnormal (Wechsler Adult Intelligence Scale<90); 6. Desiring to conceive,pregnant or lactating women; 7. Participants who had been taking anti-depression and anti-anxiety medication for 2 weeks before the trial; 8. Participant who install a pacemaker or an artificial joint. 

研究实施时间:

Study execute time:

From2019-10-01To 2022-05-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

40

Group:

Experimental group

Sample size:

干预措施:

电针

干预措施代码:

Intervention:

Electroacupuncture

Intervention code:

组别:

对照组

样本量:

40

Group:

Control group

Sample size:

干预措施:

草酸艾司西酞普兰片

干预措施代码:

Intervention:

Escitalopram Oxalate Tablets

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广东省中医院 

单位级别:

三级甲等 

Institution
hospital:

Guangdong Province Traditional Chinese Medical Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

汉密尔顿抑郁量表-17

指标类型:

主要指标 

Outcome:

HAMD-17

Type:

Primary indicator 

指标中文名:

脑电

指标类型:

次要指标 

Outcome:

Electroencephalogram

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

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:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 40 years

随机方法(请说明由何人用什么方法产生随机序列):

设置电针组和药物组(对照),两组样本量按 1:1 的比例分配。统计分析人员采用 SAS9.3 统计分析软件的“Proc plan”程序产生研究所需的随机方案

性别:

男女均可

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

Statistical analyst will set electroacupuncture group and the drug group (control),and allocate to each group in a 1:1 ratio .“Proc plan” program of SAS9.3 statistical analysis software will be used to generate the random program in this study.

Gender:

Both

盲法:

未说明

Blinding:

not stated

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

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):

2022年通过期刊论文的形式公开

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

Published in the form of periodical papers in 2022

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

本研究通过病例记录表和ResMan记录数据

The repository and management of the data(Please specify what repository will be used for management of the metadata):

This study recorded clinical data through CRFs and ResMan.

创建人:

Creater Name:

 2019-10-22
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