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北京市精神分裂症超高危人群识别干预网络的建立及中医干预方案推广研究
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注册号:

Registration number:

ChiCTR1900023106 

最近更新日期:

Date of Last Refreshed on:

2019-05-19 

注册时间:

Date of Registration:

2019-05-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

北京市精神分裂症超高危人群识别干预网络的建立及中医干预方案推广研究 

Public title:

Establishment of the identification and intervention network for the population with ultra-high-risk of schizophrenia and the popularization of traditional chinese medicine intervention scheme in Beijing 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

北京市精神分裂症超高危人群识别干预网络的建立及中医干预方案推广研究 

Scientific title:

Establishment of the identification and intervention network for the population with ultra-high-risk of schizophrenia and the popularization of traditional chinese medicine intervention scheme in Beijing 

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:

宁艳哲 

研究负责人:

贾竑晓 

Applicant:

Ning Yanzhe 

Study leader:

Jia Hongxiao 

申请注册联系人电话:

Applicant telephone:

+86 010 58303108 

研究负责人电话:

Study leader's telephone:

+86 010 58303065 

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:

yanzhening0923@163.com 

研究负责人电子邮件:

Study leader's E-mail:

jhxlj@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安康胡同5号 

Applicant address:

5 Ankang Lane, Deshengmen Street, Xicheng District, Beijing, China  

Study leader's address:

5 Ankang Lane, Deshengmen Street, Xicheng District, Beijing, 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:

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:

201919FS-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:

2019-03-06 

伦理委员会联系人:

贾晋京 

Contact Name of the ethic committee:

Jia Jinjing 

伦理委员会联系地址:

北京市西城区德胜门外安康胡同5号 

Contact Address of the ethic committee:

5 Ankang Lane, Deshengmen Street, Xicheng District, Beijing, China  

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安康胡同5号 

Primary sponsor's address:

5 Ankang Lane, Deshengmen Street, Xicheng District, Beijing, 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):

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:

西城区德胜门外安康胡同5号

Institution
hospital:

Beijing Anding Hospital, Capital Medical University

Address:

5 Ankang Lane, Deshengmen Street, Xicheng District

经费或物资来源:

北京市卫生和计划生育委员会 

Source(s) of funding:

Health and Family Planning Commission of Beijing 

研究疾病:

精神分裂症 

Target disease:

Schizophrenia 

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:

其它 

Study phase:

N/A 

研究目的:

评价石珍安神颗粒对精神分裂症超高危人群和精神分裂症人群的疗效和安全性。 

Objectives of Study:

To evaluate the treatment effects and safety of Shizhenanshen granules on ultra-high-risk of schizophrenia and first episode schizophrenia. And we will discuss the latent mechanism of the treatment. Our research will probably explore a Chinese style intervention of individuals at ultra high risk of schizophrenia.  

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. 符合研究规定的精神分裂症超高危人群或首发精神分裂症的标准; 2. 年龄18-30岁(包括18与30岁); 3. 自愿签署知情同意书并且能够依从研究方案; 4. 能理解随访问卷的调查; 5. 符合精神科中医肾阴虚火旺证证型标准(幻觉,妄想,思维怪异,思维散漫,呆楞少语,自语自笑,独处一隅,腰膝酸软,口干,便秘,舌质红,少苔,有齿痕,脉弦细数)。 

Inclusion criteria

1. meet the criteria for the study of schizophrenia, high-risk groups standards or first episode schizophrenia; 2. Aged between 18 and 30 years (including 18 and 30); 3. Sign the informed consent and be able to comply with the research scheme; 4. Understand the follow-up questionnaire survey; 5. Meet the criteria of the standard of traditional Chinese medicine syndromes of hyperactivity of fire due to deficiency of kidney yin (hallucinations, delusions, weird thinking, thinking lax, looseness of thought, stunned and speechless, automatic speaking and laughing, solitude, soreness and weakness of waist and knees, dry mouth, constipation, red tongue, Thin tongue coating with teeth marks, fine rapid stringlike pulse)  

排除标准:

1. 有严重自杀倾向者; 2. 目前有抑郁发作; 3. 伴有严重的或不稳定的心、肝、肾、内分泌、血液等内科疾病者; 4. 入选前4周内服用抗精神病药物治疗者; 5. 无人监护; 6. 基线的精神分裂症超高危人群定式访谈量表评分与筛查时相比,减分率≥25%者。 

Exclusion criteria:

1. Have severe suicidal tendencies; 2. Be in a depressive episode; 3. With serious or unstable heart, liver, kidney, endocrine, blood and other medical diseases; 4. Be treated with antipsychotic medications within 4 weeks; 5. Unattended; 6. Compared to baseline, the reduction rate of ultra-high-risk of schizophrenia structured interview scale screening score is more than 25%. 

研究实施时间:

Study execute time:

From2019-06-01To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2019-06-01To 2020-12-31 

干预措施:

Interventions:

组别:

精神分裂症超高危人群试验组

样本量:

60

Group:

ultra-high-risk of schizophrenia experimental group

Sample size:

干预措施:

服用石珍安神颗粒及阿立哌唑安慰剂

干预措施代码:

Intervention:

Take Shizhenanshen granules and aripiprazole placebo

Intervention code:

组别:

精神分裂症超高危人群对照组

样本量:

60

Group:

ultra-high-risk of schizophrenia control group

Sample size:

干预措施:

服用阿立哌唑及中药安慰剂

干预措施代码:

Intervention:

Take aripiprazole and Shizhen'anshen placebo

Intervention code:

组别:

首发精神分裂症试验组

样本量:

40

Group:

first episode schizophrenia experimental group

Sample size:

干预措施:

服用石珍安神颗粒及阿立哌唑

干预措施代码:

Intervention:

Take Shizhenanshen granules and aripiprazole

Intervention code:

组别:

首发精神分裂症试对照组

样本量:

40

Group:

first episode schizophrenia control group

Sample size:

干预措施:

服用阿立哌唑及中药安慰剂

干预措施代码:

Intervention:

Take aripiprazole and Shizhen'anshen placebo

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):

北京 

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:

三级甲等 

Institution
hospital:

Beijing Anding Hospital, Capital Medical Univercity  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

首都医科大学附属北京中医医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Hospital of Traditional Chinese medicine, Capital Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

首都医科大学附属北京友谊医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Friendship Hospital, Capital Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

北京市海淀区精神卫生防治院 

单位级别:

二级 

Institution
hospital:

Beijing Haidian District Mental Health Prevention and Control Hospital  

Level of the institution:

Secondary 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

北京市大兴区精神卫生防治院 

单位级别:

二级 

Institution
hospital:

Beijing Daxing District Mental Health Prevention and Control Hospital  

Level of the institution:

Secondary 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

北京市朝阳区第三医院 

单位级别:

二级 

Institution
hospital:

Beijing Chaoyang District Third Hospital  

Level of the institution:

Secondary 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

北京市平谷区精神卫生防治院 

单位级别:

二级 

Institution
hospital:

Beijing Pinggu District Mental Health Prevention and Control Hospital  

Level of the institution:

Secondary 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

北京市西城区平安医院 

单位级别:

二级 

Institution
hospital:

Beijing Xicheng Pingan Hospital  

Level of the institution:

Secondary 

测量指标:

Outcomes:

指标中文名:

症状学评估

指标类型:

主要指标 

Outcome:

symptoms assessment

Type:

Primary indicator 

测量时间点:

基线,4、8、12、16、20周

测量方法:

SIPS、BPRS和PANSS量表

Measure time point of outcome:

Baseline, 4, 8, 12, 16, 20 week

Measure method:

SIPS, BPRS, PANSS

指标中文名:

认知功能评估

指标类型:

主要指标 

Outcome:

assessment of cognition function

Type:

Primary indicator 

测量时间点:

基线,4、8、12、16、20周

测量方法:

认知功能评定工具

Measure time point of outcome:

Baseline, 4, 8, 12, 16, 20 week

Measure method:

MACTRIC

指标中文名:

不良反应评估

指标类型:

主要指标 

Outcome:

assessment of adverse reaction

Type:

Primary indicator 

测量时间点:

基线,4、8、12、16、20周

测量方法:

TESS量表

Measure time point of outcome:

Baseline, 4, 8, 12, 16, 20 week

Measure method:

TESS

指标中文名:

脑源性细胞营养因子、白细胞介素

指标类型:

附加指标 

Outcome:

BDNF, IL

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

功能磁共振

指标类型:

附加指标 

Outcome:

fMRI

Type:

Additional 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:

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

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 30 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):

由专职人员采用进行中央随机随机化方案的设计,并利用SAS 9.3 软件产生随机化编码,做成随机信封,并将包装一致的实验药与对照药进行编号,完成编盲。观察医生按每位患者就诊先后顺序按照药物编号从小到大顺序发放药物。

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

The central randomized method was used to generate random code by SAS 9.3 software according to the 1:1 ratio. Then the random envelopes were made. The same packaged experimental medicines were numbered to complete the blind process. According to the medicine code from small to large, the researchers dispen

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:

即时公开/Real time access

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):

自建数据库平台

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

Self-built database platform

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:

数据由研究者填写至病例报告表,研究协调员会定期检查保证数据的真实性和可靠性。病例报告表的数据再由专人录入电子数据库中,双人录入保证数据的可靠性。

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

The data were filled out by the researchers to the case report form, and the research coordinator regularly checked the authenticity and reliability of the data. The data of the case report form was then entered into the electronic database by the specially-aasigned person, and the reliability of the data was ensured by double entering.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-05-11
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