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伏硫西汀和艾司西酞普兰对抑郁症疗效、安全性及脑肠轴相关变化的研究
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注册号:

Registration number:

ChiCTR1900024858 

最近更新日期:

Date of Last Refreshed on:

2019-07-31 

注册时间:

Date of Registration:

2019-07-31 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

伏硫西汀和艾司西酞普兰对抑郁症疗效、安全性及脑肠轴相关变化的研究 

Public title:

Comparison of the efficacy and safety of vortioxetine and escitalopram in depression and the corresponding changes in Brain-Gut axis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

伏硫西汀和艾司西酞普兰对抑郁症疗效、安全性及脑肠轴相关变化的研究 

Scientific title:

Comparison of the efficacy and safety of vortioxetine and escitalopram in depression and the corresponding changes in Brain-Gut axis 

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:

矫健萍 

研究负责人:

黄满丽 

Applicant:

Jianping Jiao 

Study leader:

Manli Huang 

申请注册联系人电话:

Applicant telephone:

+86 15024616447 

研究负责人电话:

Study leader's telephone:

+86 13957162975 

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:

jjp_1113@163.com 

研究负责人电子邮件:

Study leader's E-mail:

huangmanli@zju.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:

浙江省杭州市庆春路79号 

研究负责人通讯地址:

浙江省杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang, China  

Study leader's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital, College of Medicine, Zhejiang 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:

(2019)科研快审第(1014)号 

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:

浙江大学医学院附属第一院医院科研伦理委员会 

Name of the ethic committee:

Research Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-06-25 

伦理委员会联系人:

郑敏 

Contact Name of the ethic committee:

Min Zheng 

伦理委员会联系地址:

浙江省杭州市庆春路79号 

Contact Address of the ethic committee:

79 Qingchun Road, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital, College of Medicine, Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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):

浙江省

市(区县):

杭州市

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属第一医院

具体地址:

庆春路79号

Institution
hospital:

The First Affiliated Hospital,College of Medicine, Zhejiang University

Address:

79 Qingchun Road

经费或物资来源:

浙江省重点研发计划项目经费:100万(2015C03040) 

Source(s) of funding:

Zhejiang key research and development project funding: 1 million yuan (2015C03040) 

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:

上市后药物 

Study phase:

研究目的:

1.比较两种不同抗抑郁药物的疗效和安全性以及对认知功能的影响。 2.探索抑郁症患者治疗前后神经生物学特征,从菌群、神经内分泌、神经免疫学、脑结构和功能特征探讨抑郁症患者的脑肠轴变化。 

Objectives of Study:

1. Compare the efficacy and safety of two different antidepressants and their effects on cognitive function. 2. Explore the neurobiological characteristics of patients with depression before and after treatment, and explore the changes of brain-gut axis in patients with depression from the aspects of flora, neuroendocrine, neuroimmunology, brain structure and function. 

药物成份或治疗方案详述:

心达悦:前2天5mg晚饭后口服,第三天改10mg晚饭后口服。如患者4周HAMD-17减分率<50%,可在逐渐加量至每天15mg-20mg。连续服药6个月。 来士普:前2天5mg晚饭后口服,第三天改10mg晚饭后口服。如患者4周HAMD-17减分率<50%,可逐渐加量至每天15mg-20mg。连续服药6个月。 合并用药:可以合用苯二氮卓类药物和普萘洛尔片等药物。不能合用其它抗抑郁药物和抗精神病药物。 

Description for medicine or protocol of treatment in detail:

Xinda yue: take 5mg orally after dinner for the first 2 days, and take 10mg orally after dinner for the third day.If the reduction rate of HAMD-17 is < 50% at 4 weeks, it can be gradually increased to 15mg-20mg per day.Take the drug continuously for 6 months. Leipzig: take 5mg after dinner for the first 2 days and 10mg after dinner for the third day. If the reduction rate of HAMD-17 is < 50% at 4 weeks, the amount can be gradually increased to 15mg-20mg per day. Take the drug continuously for 6 months. Drug combination: benzodiazepine and propranolol tablets can be used together. Do not combine other antidepressants and antipsychotics. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.本次发作符合DSM-V重性抑郁的诊断标准; 2.首发或复发未用药; 3.汉密尔顿抑郁评定量表HAMD-17项总分≥17; 4.汉族人,右利手; 5.初中及以上文化水平; 6.年龄18-45岁之间。 

Inclusion criteria

1. This episode met the diagnostic criteria of DSM-V major depression; 2. First or recurrence without medication; 3. Hamilton depression rating scale HAMD-17 total score >= 17; 4. Han Chinese, right-handed; 5. Junior high school education or above; 6. Aged 18 to 45 years. 

排除标准:

1.接受过抗抑郁剂或其他精神病药物治疗,或经颅磁刺激、电休克等其他抗抑郁治疗; 2.共病或曾经被诊断过其他精神障碍,或一级亲属有精神障碍史; 3.由药物或器质性因素导致的继发性精神障碍; 4.有神经系统重大疾病史(如癫痫、中风等),有重大躯体疾病史(如心脏病、高血压病、肝病等),有内分泌疾病史(如糖尿病等); 5.有酒精或药物滥用或依赖史; 6.存在磁共振检查禁忌(如金属植入物、幽闭恐惧症等)。 

Exclusion criteria:

1. Received antidepressant or other psychiatric medication, or other antidepressant treatment such as transcranial magnetic stimulation and electroconvulsive therapy; 2. Comorbidity or having been diagnosed with other mental disorders, or a first-degree relative with a history of mental disorders; 3. Secondary mental disorders caused by drugs or organic factors; 4. Have a history of major neurological diseases (such as epilepsy, stroke, etc.), major physical diseases (such as heart disease, hypertension, liver disease, etc.), and endocrine diseases (such as diabetes, etc.); 5. A history of alcohol or drug abuse or dependence; 6. MRI contraindication (e.g. metal implants, claustrophobia, etc.). 

研究实施时间:

Study execute time:

From2019-08-20To 2020-06-30 

干预措施:

Interventions:

组别:

伏硫西汀

样本量:

65

Group:

vortioxetine

Sample size:

干预措施:

伏硫西汀

干预措施代码:

1

Intervention:

vortioxetine

Intervention code:

组别:

艾司西酞普兰

样本量:

65

Group:

escitalopram

Sample size:

干预措施:

艾司西酞普兰

干预措施代码:

2

Intervention:

escitalopram

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital, College of Medicine, Zhejiang University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

心理测评量表

指标类型:

主要指标 

Outcome:

Psychological assessment scale

Type:

Primary indicator 

测量时间点:

基线,2周,4周,8周,16周,24周

测量方法:

医生评估和患者自评

Measure time point of outcome:

Baseline, 2 weeks, 4 weeks, 8 weeks, 16 weeks, 24 weeks

Measure method:

Doctor assessment and patient evaluation

指标中文名:

功能性磁共振

指标类型:

主要指标 

Outcome:

fMRI

Type:

Primary indicator 

测量时间点:

基线、24周

测量方法:

仪器检查

Measure time point of outcome:

Baseline, 24 weeks

Measure method:

Instruments to check

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

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

粪便

组织:

Sample Name:

Feces

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 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):

由陈京凯医生用计算机生成随机数字表,根据病人编号对应的随机数字表中的数字,奇数分到1组,偶数分到2组。

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

Doctor Jingkai Chen generated a random number table by computer. According to the Numbers in the random number table, odd Numbers were assigned to 1 group and even Numbers to 2 groups.

盲法:

未说明

Blinding:

Not stated

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:

试验完成后6个月内公开/Within six months after the trial complete

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):

ResMan, http://www.medresman.org

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

ResMan, http://www.medresman.org

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:

一为病例记录表(Case Record Form, CRF),每个病人均有详细的病历记录,可以随时查阅。 管理系统:ResMan

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

case record form. Each patient has detailed medical records, which can be consulted at any time. management system:ResMan

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-31
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