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Pharmacogenomic study of schizophrenia
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注册号:

Registration number:

ChiCTR-TRC-10000934 

最近更新日期:

Date of Last Refreshed on:

2015-06-14 

注册时间:

Date of Registration:

2010-07-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

精神分裂症的药物基因组学研究 

Public title:

Pharmacogenomic study of schizophrenia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

精神分裂症的基因组关联分析和药物基因组学研究 

Scientific title:

The genome-wide association and pharmacogenomic study of schizophrenia 

研究课题代号(代码):

Study subject ID:

2009AA022702 

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:

岳伟华 

研究负责人:

张岱 

Applicant:

Weihua Yue 

Study leader:

Dai Zhang 

申请注册联系人电话:

Applicant telephone:

+86 010 82801960 

研究负责人电话:

Study leader's telephone:

+86 010 82801937 

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:

dryue@bjmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

daizhang@bjmu.edu.cn 

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:

北京市海淀区花园北路51号 

研究负责人通讯地址:

北京市海淀区花园北路51号 

Applicant address:

No. 51, Hua Yuan Bei Road, Beijing, China 

Study leader's address:

No. 51, Hua Yuan Bei Road, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100191 

研究负责人邮政编码:

Study leader's postcode:

100191 

申请人所在单位:

北京大学第六医院/精神卫生研究所 

Applicant's institution:

The Sixth Hospital / Institute of Mental Health, Peking 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:

2009伦审第(23)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:

北京大学第六医院医学伦理委员会 

Name of the ethic committee:

Ethical Committee of the Sixth Hospital, Peking University. 

伦理委员会批准日期:

Date of approved by ethic committee:

2009-04-21 

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:

北京大学第六医院/精神卫生研究所 

Primary sponsor:

The Sixth Hospital / Institute of Mental Health, Peking University 

研究实施负责(组长)单位地址:

北京市海淀区花园北路51号 

Primary sponsor's address:

No. 51, Hua Yuan Bei Road, 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):

国家科技部

具体地址:

北京市海淀区复兴路乙15 号

Institution
hospital:

The Ministry of Science and Technology

Address:

15 Fuxin Road, Haidian, Beijing

经费或物资来源:

国家高技术研究发展计划(863 计划) 

Source(s) of funding:

The National High Technology Research and Development Program of China (863 program) 

研究疾病:

精神分裂症 

Target disease:

Schizophrenia 

研究疾病代码:

181500 

Target disease code:

181500 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

揭示精神分裂症发病的遗传基础以及药物治疗安全性和有效性的药物遗传学基础 

Objectives of Study:

To explore the genetic mechnisms of individual difference of the antipsychotics. 

药物成份或治疗方案详述:

奥氮平 非典型抗精神病药奥氮平 奋乃静 典型抗精神病药奋乃静 阿立哌唑 非典型抗精神病药阿立哌唑 齐拉西酮 非典型抗精神病药齐拉西酮 氟哌啶醇 

Description for medicine or protocol of treatment in detail:

Quetiapine Atypical antipsychotic drug Quetiapine Risoeridone Atypical antipsychotic drug Ri 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

符合DSM-IV精神分裂症诊断标准; 发病年龄16-45岁; 患者本人及其生物学父母均为中国汉族; 首发精神分裂症患者或慢性患者急性恶化; 阳性与阴性症状量表(PANSS)评分≥70 分; 受试者对研究知情并签署知情同意书。 

Inclusion criteria

1. Both the patients and their parents are Chinese Han descents; 2. The schizophrenia patients at first-onset or the chronic patients with acute and severe symptoms; 3. The total scores of the PANSS are more than 70; 4. All of the subjects give the written informed consent. 

排除标准:

精神障碍是继发于器质性躯体疾病; 物质滥用所致精神障碍(酒、药物等); 符合 DSM-IV 的分裂情感性精神障碍、精神发育迟滞、广泛性发育障碍、谵妄、痴呆、记忆障碍或其他认知障碍者; 孕期及哺乳期女性病人; 对于本课题推荐的抗精神病药物有禁忌症的患者; 严重的或急性不稳定性躯体疾病; 患者心脏有如下问题被排除:QTc 间期延长(心电图扫描男性 QTc>450 毫秒,或女性 QTc>470 毫秒),失代偿性的充血性心衰,完全性左束支传导阻滞。 

Exclusion criteria:

1. Patients with pregnancy or breast-feeding; 2. Patients with the contraindications of the recommended drugs; 3. Patients with severe or unstable physical diseases; 4. Patients with following heart diseases: QTc>450 ms in male, or QTc>470ms in female; Decompensated and congestive heart failure; Complete left bundle branch block delay. 

研究实施时间:

Study execute time:

From2009-01-01To 2011-12-31 

干预措施:

Interventions:

组别:

1

样本量:

500

Group:

1

Sample size:

干预措施:

奋乃静16~64 mg/d或氟哌啶醇6~20 mg/d,各250例

干预措施代码:

Intervention:

Perphenazine 16-64 mg/d (N=250) or Haloperidol 6-20 mg/d (N=250)

Intervention code:

组别:

2

样本量:

500

Group:

2

Sample size:

干预措施:

利培酮2~6mg/d

干预措施代码:

Intervention:

Risperidone 2-6mg/d

Intervention code:

组别:

3

样本量:

500

Group:

3

Sample size:

干预措施:

奥氮平5~20 mg/d

干预措施代码:

Intervention:

Olanzapine 5-20 mg/d

Intervention code:

组别:

4

样本量:

500

Group:

4

Sample size:

干预措施:

阿立哌唑10~30 mg/d

干预措施代码:

Intervention:

Quetiapine 400-750mg/d

Intervention code:

组别:

5

样本量:

500

Group:

5

Sample size:

干预措施:

阿立哌唑10~30 mg/d

干预措施代码:

Intervention:

Aripiperazole 10~30 mg/d

Intervention code:

组别:

6

样本量:

500

Group:

6

Sample size:

干预措施:

齐拉西酮80~160 mg/d

干预措施代码:

Intervention:

Ziprasidone 80-160 mg/d

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):

北京大学 

单位级别:

教育部直属高校 

Institution
hospital:

Peking University  

Level of the institution:

Tertiary A hospital 

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 

单位级别:

教育部直属高校 

Institution
hospital:

Capital Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hunan 

City:

Changsha 

单位(医院):

中南大学 

单位级别:

教育部直属高校 

Institution
hospital:

Central South University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学 

单位级别:

教育部直属高校 

Institution
hospital:

Sichuan University.  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

阳性与阴性症状量表(PANSS)

指标类型:

主要指标 

Outcome:

Reduction rate of PANSS total score

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 16 years
最大 Max age 45 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

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

random number table

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

北京大学第六医院/精神卫生研究所

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

The Sixth Hospital / Institute of Mental Health, Peking University.

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:

北京大学第六医院/精神卫生研究所

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

The Sixth Hospital / Institute of Mental Health, Peking University.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2010-07-06
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