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评价口服8周阿戈美拉汀(25mg/日,可调整剂量至50mg/日)治疗门诊抑郁症患者的疗效和安全性
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注册号:

Registration number:

ChiCTR-TRC-11001668 

最近更新日期:

Date of Last Refreshed on:

2015-07-22 

注册时间:

Date of Registration:

2011-11-01 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

评价口服8周阿戈美拉汀(25mg/日,可调整剂量至50mg/日)治疗门诊抑郁症患者的疗效和安全性 

Public title:

Efficacy and safety of agomelatine with flexible dose (25 mg/day with potential adjustment at 50 mg) given orally for 8 weeks in out-patients with Major Depressive Disorder. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价口服8周阿戈美拉汀(25mg/日,可调整剂量至50mg/日)治疗门诊抑郁症患者的疗效和安全性 

Scientific title:

Efficacy and safety of agomelatine with flexible dose (25 mg/day with potential adjustment at 50 mg) given orally for 8 weeks in out-patients with Major Depressive Disorder. A randomised flexible dose double-blind international multicentric study with parallel groups, versus fluoxetine (20 mg/day wi 

研究课题代号(代码):

Study subject ID:

CL3-20098-052 

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:

张艳红 

研究负责人:

舒良 教授 

Applicant:

Zhang Yanhong 

Study leader:

Prof. Shu Liang 

申请注册联系人电话:

Applicant telephone:

+86 10 65610341-308 

研究负责人电话:

Study leader's telephone:

+86 10 82028364 

申请注册联系人传真 :

Applicant Fax:

+86 10 85875160 

研究负责人传真:

Study leader's fax:

+86 10 82028364 

申请注册联系人电子邮件:

Applicant E-mail:

linda.zhang@cn.netgrs.com 

研究负责人电子邮件:

Study leader's E-mail:

shu-liang@126.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:

北京市朝阳区东三环中路1号环球金融中心西楼6层 

研究负责人通讯地址:

北京大学精神卫生研究所,北京市海淀区花园北路51号 

Applicant address:

West Building 6th Floor World Financial Centre, 1 East 3rd Ring Middle Road, Chaoyang District, Beijing 

Study leader's address:

Clinical Trial Center, Mental Health Institute, Peking University, 51 North Huayuan Road, Haidian District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100020 

研究负责人邮政编码:

Study leader's postcode:

100083 

申请人所在单位:

施维雅国际研究中心 

Applicant's institution:

Institut de Recherche Internationales Servier 

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:

2007-15 

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(精神卫生研究所)医学伦理委员会 

Name of the ethic committee:

Peking University Sixth Hospital (Mental Health Institute) Ethic Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2007-04-30 

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:

施维雅国际研究中心 

Primary sponsor:

Institut de Recherche Internationales Servier 

研究实施负责(组长)单位地址:

50 rue Carnot 92284 Suresnes Cedex 法国 

Primary sponsor's address:

50 rue Carnot 92284 Suresnes Cedex France 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

施维雅国际研究中心 

Source(s) of funding:

Institut de Recherche Internationales Servier 

研究疾病:

抑郁症 

Target disease:

Major Depressive Disorder 

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:

III期临床试验 

Study phase:

研究目的:

与氟西汀比较,评价阿戈美拉汀治疗亚洲门诊中重度抑郁症患者8周的疗效和安全性 

Objectives of Study:

To assess the agomelatine efficacy and safety in comparison to fluoxetine after an 8-week treatment period in Asian out-patients suffering from moderate to severe Major Depressive Disorder. 

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:

亚洲的门诊抑郁症患者,男女均可,年龄18~65岁(含18岁和65岁),符合精神障碍诊断统计手册-第四版-修订稿(DSM-IV-TR )规定的抑郁症诊断标准,严重度为中重度。 

Inclusion criteria

Ambulatory male or female Asian patients aged from 18 to 65 years (both inclusive), fulfilling DSM-IV-TR criteria for MDD of moderate to severe intensity 

排除标准:

1.妊娠、哺乳或研究期间未使用可靠的避孕措施的妇女。 2.除抑郁症之外的各型抑郁。 3.所有其他精神疾病。 

Exclusion criteria:

1. Pregnancy, breastfeeding or possibility of becoming pregnant during the study without an effective contraception; 2. All types of depression other than major depressive disorder; 3. All other psychiatric disorders. 

研究实施时间:

Study execute time:

From2006-08-16To 2008-07-21 

干预措施:

Interventions:

组别:

阿戈美拉汀

样本量:

314

Group:

Agomelatine

Sample size:

干预措施:

阿戈美拉汀,25或50mg,片剂,口服

干预措施代码:

Intervention:

Oral Valdoxan, Agomelatine, 25 or 50mg, tablets

Intervention code:

组别:

氟西汀

样本量:

314

Group:

Fluoxetine

Sample size:

干预措施:

氟西汀,20或40mg,胶囊,口服

干预措施代码:

Intervention:

Oral Prozac, Fluoxetine, 20 or 40mg capsules

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

香港 

市(区县):

 

Country:

China 

Province:

Hong kong 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

 

Level of the institution:

 

国家:

中国 

省(直辖市):

香港 

市(区县):

 

Country:

China 

Province:

Hong kong 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

 

Level of the institution:

 

国家:

韩国 

省(直辖市):

 

市(区县):

 

Country:

South Korea 

Province:

 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

 

Level of the institution:

 

国家:

中国 

省(直辖市):

台湾 

市(区县):

 

Country:

China 

Province:

Taiwan 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

 

Level of the institution:

 

国家:

马来西亚 

省(直辖市):

 

市(区县):

 

Country:

Malaysia 

Province:

 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

 

Level of the institution:

 

国家:

新加坡 

省(直辖市):

 

市(区县):

 

Country:

Singapore 

Province:

 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

 

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

抑郁,17项汉密尔顿抑郁评定量表:从基线到W8的改变

指标类型:

主要指标 

Outcome:

Depression-Hamilton Depression Rating Scale 17 items: change from baseline to W8

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁,临床总体印象量表(CGI):从基线到W8的改变

指标类型:

次要指标 

Outcome:

Depression-Clinical Global Improvement scale: change from baseline to W8

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睡眠,从W1到W8,评估Leeds睡眠评定问卷(LSEQ)

指标类型:

次要指标 

Outcome:

sleep-Leeds Sleep Evaluation Questionnaire (LSEQ) from W1 to W8

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

焦虑,从基线到W8,评估汉密尔顿焦虑量表(HAM-A)

指标类型:

次要指标 

Outcome:

anxiety-Hamilton Anxiety Rating Scale (HAM-A) from baseline to W8

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

耐受,不良事件,实验室检查,体格检查,心电图

指标类型:

次要指标 

Outcome:

Tolerance-Emergence of adverse events, laboratory parameters, vital signs, electrocardiograms

Type:

Secondary 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 18 years
最大 Max age 65 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):

RCT

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

RCT

盲法:

所有治疗具有相同的外观

Blinding:

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):

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:

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2011-11-01
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