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抗抑郁剂联合心境稳定剂对双相障碍抑郁发作维持治疗的随机对照研究
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注册号:

Registration number:

ChiCTR2000031256 

最近更新日期:

Date of Last Refreshed on:

2020-03-26 

注册时间:

Date of Registration:

2020-03-26 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

抗抑郁剂联合心境稳定剂对双相障碍抑郁发作维持治疗的随机对照研究 

Public title:

Combination of antidepressants with mood stabilizers for the maintenance treatment of bipolar depression: a randomized controlled study. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

双相障碍抑郁发作药物维持治疗的疗效和安全性研究 

Scientific title:

Efficacy and safety of maintenance treatment in patients with bipolar disorder depressive episode 

研究课题代号(代码):

Study subject ID:

首都卫生发展科研专项,项目编号2014-4-2123 

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:

王雪 

研究负责人:

王雪 

Applicant:

Wang Xue 

Study leader:

Wang Xue 

申请注册联系人电话:

Applicant telephone:

+86 13466587257 

研究负责人电话:

Study leader's telephone:

+86 13466587257 

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:

xuew37@aliyun.com 

研究负责人电子邮件:

Study leader's E-mail:

xuew37@aliyun.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, Deshengmennwai Avenue, Xicheng District, Beijing, China  

Study leader's address:

5 Ankang Lane, Deshengmenwai Avenue, Xicheng District, Beijing, China  

申请注册联系人邮政编码:

Applicant postcode:

100088 

研究负责人邮政编码:

Study leader's postcode:

100088 

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:

2015129FS-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:

The Ethics Committee of Beijing Anding Hospital, Capital Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2015-09-23 

伦理委员会联系人:

贾京津 

Contact Name of the ethic committee:

Jia Jingjin 

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, Deshengmenwai Avenue, Xicheng District, Beijing, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 13718685272 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

anding_lunli@sina.com 

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, Deshengmenwai Avenue, 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, Deshengmenwai Avenue, Xicheng District

经费或物资来源:

首都卫生发展科研专项 

Source(s) of funding:

Capital health development research project 

研究疾病:

双相情感障碍 

Target disease:

bipolar 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:

上市后药物 

Study phase:

研究目的:

1)评价抗抑郁剂联合心境稳定剂对双相障碍抑郁发作维持治疗的疗效和安全性; 2)探讨抗抑郁剂在双相障碍抑郁发作维持治疗中的价值。 

Objectives of Study:

1) To evaluate the efficacy and safety of antidepressants combined with mood stabilizers in the maintenance treatment of bipolar depression; 2) To explore the value of antidepressants in the maintenance treatment of bipolar depression. 

药物成份或治疗方案详述:

本研究分为三个阶段: 1)预备期:将符合DSM-IV双相I型与II型障碍抑郁发作的患者给予抗抑郁剂联合心境稳定剂治疗,为期8-12周。 2)导入期:经过急性期治疗,符合临床缓解标准(HAMD-17≤7分,YMRS≤12分,CGI-S≤2分)进入导入期,为期2周,急性期治疗12周后不符合缓解标准的患者不纳入本研究。 3)观察期:导入期满2周后将患者按照1:1的比例随机分为两组,一组继续维持原有药物,即抗抑郁剂联合心境稳定剂,另一组在4周内减量停用抗抑郁剂,继续心境稳定剂维持治疗。观察期为期1年。 

Description for medicine or protocol of treatment in detail:

This study is divided into three stages: 1) Preparation period: Patients with DSM-IV-defined bipolar I and II depression were treated by antidepressants combined with mood stabilizers for 8-12 weeks. 2) Lead-in period: After the treatment in acute phase, patients who met the clinical remission standard (HAMD-17 <= 7 points, YMRS <= 12 points, CGI-S <= 2 points) entered the lead-in period for 2 weeks. Patients who did not meet the remission standard after 12 weeks treatment in acute phase could not be included in this study. 3) Observation period: Patients were randomly divided into two groups according to the ratio of 1:1 two weeks after the lead-in period. One group continued to maintain the original drug, that is, antidepressants combined with mood stabilizers. The other group reduced and stopped antidepressants within four weeks, and continued to maintain mood stabilizers. The observation period is one year. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1)符合DSM-IV中双相I型或双相II型障碍抑郁发作诊断标准; 2)入组前3个月之内有一次重性抑郁发作,且最近一次发作为重性抑郁发作; 3)符合临床缓解标准,定义为HAMD-17≤7分,YMRS≤7分,CGI-S≤2分持续至少2周; 4)年龄18-65岁; 5)患者自愿参与研究,本人签署知情同意书。 

Inclusion criteria

1) Meet the diagnostic criteria of bipolar I or bipolar II depression in DSM-IV; 2) A major depressive episode occurred within 3 months before enrollment, and the most recent episode was a major depressive episode; 3) Meet clinical remission criteria, defined as HAMD-17 <= 7 points, YMRS <= 7 points, CGI-S <= 2 points for at least 2 weeks; 4) 18-65 years old; 5) Patients voluntarily participated in the study and signed the informed consent by him/herself. 

排除标准:

1)既往诊断精神分裂症、分裂情感性精神障碍或其它疾病伴发的精神障碍者; 2)共病人格障碍或精神发育迟滞者; 3)入选前1年有物质滥用或依赖者; 4)研究者认为有严重自杀风险或HAMD-17第3项(自杀项)得分≥3分; 5)目前有严重躯体疾病研究者认为不适合入组本项研究; 6)妊娠或哺乳期妇女,或计划妊娠者,或不同意采用避孕者; 7)入选前1个月内接受过电痉挛治疗者; 8)入选前1年曾参加另一项干预性临床研究者。 

Exclusion criteria:

1) Have been diagnosed of schizophrenia, schizoaffective disorder or other mental disorders associated with diseases; 2) Comorbid personality disorder or mental retardation; 3) Have substance abuse or dependence within 1 year before enrollment; 4) Currently have a serious risk of suicide judged by investigators or HAMD-17 item 3 (suicide item) score >= 3 points; 5) Currently have severe physical illnesses which researchers think it is risky and not eligible to participate; 6) Pregnant or lactating women, or those who are planning to become pregnant, or who do not agree with contraception; 7) Have received electroconvulsive therapy within 1 month before enrollment; 8) Have participated in another interventional clinical study within 1 year before enrollment. 

研究实施时间:

Study execute time:

From2015-09-25To 2018-12-31 

干预措施:

Interventions:

组别:

Group 1

样本量:

52

Group:

Group 1

Sample size:

干预措施:

抗抑郁剂联合心境稳定剂

干预措施代码:

Intervention:

antidepressants combined with mood stabilizers

Intervention code:

组别:

Group 2

样本量:

52

Group:

Group 2

Sample size:

干预措施:

心境稳定剂

干预措施代码:

Intervention:

mood stabilizers

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):

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 University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

复发时间

指标类型:

主要指标 

Outcome:

Time to recurrence

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

复发率评定

指标类型:

次要指标 

Outcome:

Assessment of recurrence rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

再住院率评定

指标类型:

次要指标 

Outcome:

Assessment of rehospitalization

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

服药依从性

指标类型:

次要指标 

Outcome:

Pharmacotherapy compliance

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

汉密尔顿抑郁量表

指标类型:

次要指标 

Outcome:

Hamilton Depression Rating Score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

杨氏躁狂评定量表

指标类型:

次要指标 

Outcome:

young manic rating scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床总体印象量表

指标类型:

次要指标 

Outcome:

Clinical Global Impression

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总体评价量表

指标类型:

次要指标 

Outcome:

Globle assessment scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良反应发生率

指标类型:

副作用指标 

Outcome:

The incidence of adverse events

Type:

Adverse events 

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:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

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 62 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,采用SAS 软件proc plan 过程,用区组随机的方法产生。

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

Random number table will generated by using SAS software proc plan with a random block method.

盲法:

结果评估:盲

Blinding:

Results assessor: Blind

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

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):

通过ResMan共享(http://www.medresman.org.cn),首都医科大学附属北京安定医院

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

IPD will be public accessable via ResMan (http://www.medresman.org.cn), Beijing Anding hospital affiliated capital medical 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:

原始记录、病例记录表均由首都医科大学附属北京安定医院伦理委员会办公室人员统一监查、管理。

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

The original records of cases、case report forms will be unified monitoring and management by Ethics Committee of Beijing Anding hospital.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-26
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