Today is 2019-11-15

Screening for early diagnosis biomarkers of mental disorders in serum exosomes
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注册号:

Registration number:

ChiCTR1900026776 

最近更新日期:

Date of Last Refreshed on:

2019-10-21 

注册时间:

Date of Registration:

2019-10-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

血清外泌体中筛选精神疾病早期诊断标志物研究 

Public title:

Screening for early diagnosis biomarkers of mental disorders in serum exosomes 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

血清外泌体中筛选精神疾病早期诊断标志物研究 

Scientific title:

Screening for early diagnosis biomarkers of mental disorders in serum exosomes 

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:

杜鑫哲 

研究负责人:

李忻蓉 

Applicant:

Xinzhe Du 

Study leader:

Xinrong Li 

申请注册联系人电话:

Applicant telephone:

+86 15135130091 

研究负责人电话:

Study leader's telephone:

+86 18635107987 

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:

314116430@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

18635107987@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:

山西省太原市迎泽区解放南路85号 

研究负责人通讯地址:

山西省太原市迎泽区解放南路85号 

Applicant address:

85 Jiefang Road, Yingze District, Taiyuan, Shanxi, China 

Study leader's address:

85 Jiefang Road, Yingze District, Taiyuan, Shanxi, 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:

山西医科大学第一医院 

Applicant's institution:

The First Hospital of Shanxi Medical Unversity 

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]伦审字(K039)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:

山西医科大学第一医院伦理委员会 

Name of the ethic committee:

Ethics Committee of First Hospital of Shanxi Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-09-09 

伦理委员会联系人:

牛雅蓉 

Contact Name of the ethic committee:

Yarong Niu 

伦理委员会联系地址:

山西省太原市解放南路85号 

Contact Address of the ethic committee:

85 Jiefang Road, Yingze District, Taiyuan, Shanxi, 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:

山西医科大学第一医院 

Primary sponsor:

The First Hospital of Shanxi Medical Unversity 

研究实施负责(组长)单位地址:

山西省太原市迎泽区解放南路85号 

Primary sponsor's address:

85 Jiefang Road, Yingze District, Taiyuan, Shanxi, 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):

山西

市(区县):

太原

Country:

China

Province:

Shanxi

City:

Taiyuan

单位(医院):

山西医科大学第一医院

具体地址:

迎泽区解放南路85号

Institution
hospital:

The First Hospital of Shanxi Medical Unversity

Address:

85 Jiefang Road, Yingze District

经费或物资来源:

山西省“136兴医工程” 

Source(s) of funding:

the 136 Medical Rejuvenation Project of Shanxi Province 

研究疾病:

精神疾病 

Target disease:

Mental disorders 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

在正常人与精神分裂症、抑郁症、双向情感障碍症患者血清的外泌体中寻找精神疾病早期诊断的分子标记物,为精神疾病的早期诊断提供理论依据与可行技术。 

Objectives of Study:

Searching for molecular biomarkers for early diagnosis of mental disorders in serum exosomes of patients with schizophrenia, depression and bipolar disorder, to provide theoretical basis and feasible technology for early diagnosis of mental diseases. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

情感障碍患者 1. 患者必须能够配合所有的研究步骤,并签署知情同意书,自愿参加本研究; 2. 患者依从性较高,能够按时随访; 3. 18岁≤年龄≤55岁; 4. 患者符合美国疾病诊断分类手册第五版(DSM-5)诊断标准(使用简明国际神经精神访谈MINI)抑郁发作及双相情感障碍的患者(或者符合ICD-10中、重度抑郁发作的诊断标准/双相情感障碍的诊断标准),可以配合治疗; 5. 从未规律使用药物; 首发精神分裂症患者 1. 患者必须能够配合所有的研究步骤,并签署知情同意书,自愿参加本研究; 2. 患者依从性较高,能够按时随访; 3. 18岁≤年龄≤55岁; 4. 患者符合美国疾病诊断分类手册第五版(DSM-5)诊断标准(使用简明国际神经精神访谈MINI)精神分裂症的患者(或者符合ICD-10中精神分裂症),可以配合治疗; 5. 筛选访视及基线访视时阳性与阴性症状量表(PANSS)评分≥60分 6. 从未规律使用药物; 7. 若正在使用药物,但临床医生认为需要换药者(疗效差或者不能耐受)。 

Inclusion criteria

Affective disorder 1. Be able to cooperate with all study procedures and sign informed consent to participate in the study voluntarily. 2. Have high compliance and were able to follow up on time. 3. Aged 18 to 55 years. 4. Meet the DSM-5 diagnostic criteria (using the concise international neuropsychiatric interview MINI) for depressive episodes and bipolar disorder (or who meet the ICD-10 diagnostic criteria for moderate and major depressive episodes/bipolar disorder diagnostic criteria) and can cooperate with treatment. 5. Never use drugs regularly. First episode schizophrenia 1. Be able to cooperate with all study procedures and sign informed consent to participate in the study voluntarily. 2. Have high compliance and were able to follow up on time. 3. Aged 18 to 55 years. 4. Meet the DSM-5 diagnostic criteria (using the concise international neuropsychiatric interview MINI) for schizophrenia (or who meet the ICD-10 diagnostic criteria for schizophrenia) and can cooperate with treatment. 5. Positive and negative symptom scale (PANSS) score at >= 60 points at screening visit and baseline visit. 6. Never use drugs regularly. 7. If a drug is being used but the clinician thinks a change is needed (poor efficacy or intolerance). 

排除标准:

情感障碍患者 1. 精神病史: 不能除外其他器质性或药物引起的继发性抑郁障碍、或双相障碍; 目前有严重自杀倾向或严重冲动倾向者。 其他严重精神障碍病史; 有酒或其他物质依赖或滥用证据者。 2 其他病史: 有严重的躯体疾病及脑器质性疾病; 实验室或体格检查发现明确躯体或神经系统严重疾病并未消除。 3 治疗史: 必需长期合并使用具有中枢神经系统作用的药物或可能影响情绪的药物者; 4 生育史: 妊娠或哺乳期女性。 5 其他 有磁共振成像检查禁忌症(一些特殊人群不能进行MRI检查,例如:妊娠、带有心脏起搏器的患者、颅脑手术后存有动脉瘤夹的患者、铁磁性植入物患者、心脏手术后换有人工金属瓣膜者、有合金假体或金属关节患者、体内有胰岛素泵或神经刺激器患者等); 30天内参加过其他临床试验。 

Exclusion criteria:

Affective disorder 1. Psychiatric history Do not exclude other organic or medically induced secondary depressive disorder, or bipolar disorder. Have severe suicidal or impulsive tendencies at present. Have a history of other serious mental disorders. Have evidence of alcohol or other substance dependence or abuse. 2. Other medical history Have serious physical diseases and organic brain diseases. Have a serious disease of the body or nervous system revealed by laboratory or physical examination that had not been eliminated. 3. Medical history Take drugs that have central nervous system effects or that may affect mood with long-term. 4. Childbearing history Woman who is pregnant or lactating. 5.Others Have a contraindication to MRI. Participated in other clinical trials within 30 days. First episode schizophrenia Do not exclude other organic or medically induced secondary depressive disorder, or bipolar disorder Have severe suicidal or impulsive tendencies at present. Have a history of other serious mental disorders. Have evidence of alcohol or other substance dependence or abuse. 2. Other medical history Have serious physical diseases and organic brain diseases. Have a serious disease of the body or nervous system revealed by laboratory or physical examination that had not been eliminated. 4. Childbearing history Woman who is pregnant or lactating. 5.Others Cannot take medication as prescribed or do not have guardians. Have a contraindication to MRI. Participated in other clinical trials within 30 days. 

研究实施时间:

Study execute time:

From2019-10-17To 2020-12-31 

干预措施:

Interventions:

组别:

正常对照

样本量:

115

Group:

control group

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

精神分裂症

样本量:

615

Group:

Schizophrenia group

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

抑郁症

样本量:

615

Group:

depressive disorder group

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

双相情感障碍

样本量:

615

Group:

bipolar affective disorder

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

山西医科大学第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Hospital of Shanxi Medical Unversity  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

山西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

武警山西省总队医院 

单位级别:

三级甲等 

Institution
hospital:

Shanxi Provincial Armed Police Corps Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

山西省 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

山西省太原市精神病医院 

单位级别:

三级甲等 

Institution
hospital:

Taiyuan Psychiatric Hospital of Shanxi Province  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

山西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

山西省荣军精神康宁医院 

单位级别:

三级甲等 

Institution
hospital:

Rongjun Spiritual Kangning Hospital of Shanxi Province  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

山西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

山西省长治市精神卫生中心 

单位级别:

一级 

Institution
hospital:

Changzhi Mental Health Center of Shanxi Province  

Level of the institution:

Primary 

测量指标:

Outcomes:

指标中文名:

认知功能

指标类型:

主要指标 

Outcome:

cognitive function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

认知功能

指标类型:

主要指标 

Outcome:

cognitive function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心理状况

指标类型:

主要指标 

Outcome:

psychologic status

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

头颅核磁

指标类型:

主要指标 

Outcome:

Head mri

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脑电

指标类型:

主要指标 

Outcome:

electroencephalography

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:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 55 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):

不适用

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

Not applicable.

盲法:

N/A

Blinding:

N/A

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:

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://wwww.medresman.org.cn.

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

Resman, http://wwww.medresman.org.cn.

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:

Resman

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

Resman

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-10-21
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