青少年情绪障碍与自杀的发病机理、早期识别和防治的基础研究

注册号:

Registration number:

ChiCTR-PCH-12002225 

最近更新日期:

Date of Last Refreshed on:

2015-08-14 21:24:34 

注册时间:

Date of Registration:

2012-05-23 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

青少年情绪障碍与自杀的发病机理、早期识别和防治的基础研究

Public title:

Basic researches on the adolescent mood disorders and the pathogenesis, early identification, prevention and the treatment of suicide

注册题目简写:

English Acronym:

研究课题的正式科学名称:

青少年情绪障碍与自杀的发病机理、早期识别和防治的基础研究

Scientific title:

Basic researches on the adolescent mood disorders and the pathogenesis, early identification, prevention and the treatment of suicide

研究课题代号(代码):

Study subject ID:

重庆市自然科学基金计划重点项目CSCT2011BA5040

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:

徐小明 

研究负责人:

况利 

Applicant:

Xiaoming Xu 

Study leader:

Li Kuang 

申请注册联系人电话:

Applicant telephone:

+86 13983472474

研究负责人电话:

Study leader's
telephone:

+86 13908379733

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:

muaixiaoxia@hotmail.com

研究负责人电子邮件:

Study leader's E-mail:

kuangli0308@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:

重庆医科大学38#

研究负责人通讯地址:

重庆医科大学附属第一医院精神科

Applicant address:

Chongqing Medical University 38#

Study leader's address:

the Psychiatry Department of The First Affiliated Hospital of Chongqing Medical University

申请注册联系人邮政编码:

Applicant postcode:

400016

研究负责人邮政编码:

Study leader's postcode:

400016

申请人所在单位:

重庆医科大学

Applicant's institution:

Chongqing Medical University

研究负责人所在单位:

Affiliation of the Leader:

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2011年科伦审(16)号

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:

重庆医科大学附属第一医院生物医学伦理委员会

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Chongqing Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2011-11-14 00:00:00

伦理委员会联系人:

Contact Name of the ethic committee:

伦理委员会联系地址:

Contact Address of the ethic committee:

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:

重庆医科大学附属第一医院

Primary sponsor:

The First Affiliated Hospital of Chongqing Medical University

研究实施负责(组长)单位地址:

重庆医科大学附属第一医院

Primary sponsor's address:

The First Affiliated Hospital of Chongqing Medical University

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

重庆市自然科学基金计划重点项目(编号:CSCT2011BA5040)

Source(s) of funding:

Chongqing Natural and Science Fund (Numbers: CSCT2011BA5040)

研究疾病:

自杀、情绪障碍  

Target disease:

Suicide 、mood disroder

研究疾病代码:

Target disease code:

研究类型:

预防性研究

Study type:

Prevention

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

队列研究 

Study design:

Cohort study 

研究目的:

1.建立一个中国青少年情绪障碍和自杀问题的早期评估和预警模型;建立一个方便、保密的网络心理问题筛查系统, 2生物学病因机制研究:在病例对照研究中通过遗传和功能磁共振研究评估下述问题的特征和危险因素:心境障碍、焦虑障碍、自杀死亡、自杀未遂、暴力攻击行为、网络成瘾障碍、物质滥用依赖和病理性赌博。  

Objectives of Study:

1. Found a model used in early assessment and warning of mood disorder and suicide in Chinese adolescents; 2. Biological etiology and mechanism: evaluate the characteristics and risk factors for the following issues in adolescents: mood disorders, anxiety disorders, suicide, attempted suicide, violence and aggressive behavior, internet addiction disorder, substance abuse or dependence and pathological gambling with the help of genetic test and fMRI.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1.筛查中无精神疾病诊断者并且无自杀自伤行为的大中学生。
2.恐血症者

Exclusion criteria:

1. students without mental disease, suicide nor self-injury behavior;
2. students with blood phobia.

研究实施时间:

Study execute time:

From 2012-01-01 00:00:00 To 2014-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2012-12-01 00:00:00 To 2014-12-31 00:00:00

干预措施:

Interventions:

组别:

测试组

样本量:

150000

Group:

test group

Sample size:

干预措施:

网络问卷

干预措施代码:

Intervention:

web based survey

Intervention code:

组别:

心境障碍组

样本量:

100

Group:

mood disorders group

Sample size:

干预措施:

采血

干预措施代码:

Intervention:

blood sample

Intervention code:

组别:

焦虑障碍组

样本量:

100

Group:

anxiety disorders group

Sample size:

干预措施:

采血

干预措施代码:

Intervention:

blood sample

Intervention code:

组别:

自杀未遂组

样本量:

100

Group:

attempt suicide group

Sample size:

干预措施:

采血

干预措施代码:

Intervention:

blood sample

Intervention code:

组别:

冲动攻击组

样本量:

100

Group:

agressive behavior group

Sample size:

干预措施:

采血

干预措施代码:

Intervention:

blood sample

Intervention code:

组别:

成瘾组

样本量:

100

Group:

addiction disorder

Sample size:

干预措施:

采血

干预措施代码:

Intervention:

blood sample

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

重庆 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学附属第一医院 

单位级别:

三级甲等医院 

Institution
hospital:

The First Affiliated Hospital of Chongqing Medical University

Level of the institution:

Tertiary A hospital

测量指标:

Outcomes:

指标中文名:

遗传标记

指标类型:

主要指标

Outcome:

Genetic marker

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:

征募研究对象情况:

Recruiting status:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 12 years
最大 Max age 28 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):

非随机对照

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

nonrandom

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

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

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:

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

注册人:

Name of Registration:

 2012-06-06 00:00:00