中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2000036322
最近更新日期： Date of Last Refreshed on：	2020-09-06 10:48:50
注册时间： Date of Registration：	2020-08-22 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	难治性精神分裂症早期预测的神经影像学和遗传学研究
Public title：	Neuroimaging and Genetic Studies of Early Prediction of Treatment-resistant
注册题目简写：
English Acronym：
研究课题的正式科学名称：	难治性精神分裂症早期预测的神经影像学和遗传学研究
Scientific title：	Neuroimaging and Genetic Studies of Early Prediction of Treatment-resistant
研究课题代号(代码)： Study subject ID：	国家自然科学基金（81871057）
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：	唐劲松	研究负责人：	唐劲松
Applicant：	Tang Jinsong	Study leader：	Tang Jinsong
申请注册联系人电话： Applicant telephone：	+86 13627311963	研究负责人电话： Study leader's telephone：	+86 13627311963
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：	tangjinsong@zju.edu.cn	研究负责人电子邮件： Study leader's E-mail：	tangjinsong@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：	中国浙江杭州市江干区庆春东路3号	研究负责人通讯地址：	中国浙江杭州市江干区庆春东路3号
Applicant address：	3 Qingchun Road East, Jianggan District, Hangzhou, Zhejiang, China	Study leader's address：	3 Qingchun Road East, Jianggan District, Hangzhou, Zhejiang, China
申请注册联系人邮政编码： Applicant postcode：	310016	研究负责人邮政编码： Study leader's postcode：	310016
申请人所在单位：	浙江大学医学院附属邵逸夫医院精神科
Applicant's institution：	Department of Psychiatry, Sir Run-Run Shaw Hospital, School of Medicine, Zhejiang University
研究负责人所在单位：	浙江大学医学院附属邵逸夫医院精神科
Affiliation of the Leader：	Department of Psychiatry, Sir Run-Run Shaw Hospital, School 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：	(2018)伦审[科]第009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：	中南大学湘雅二医院国家临床医学研究中心伦理委员会
Name of the ethic committee：	Second Xiangya Hospital Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2019-01-02 00:00:00
伦理委员会联系人：	周智广；江冰；赵靖平；彭文兴；周后德；唐湘祁；谭立文
Contact Name of the ethic committee：	Zhou, zhiguang; Jiang, bing; Zhao, jingping; Peng, wenxing; Zhou, houde; Tang, xiangqi; Tan, liwen.
伦理委员会联系地址：	湖南省长沙市人民中路139号
Contact Address of the ethic committee：	The Second Xiangya Hospital, Central South University, 139 Middle Renmin Road, Changsha, Hu'nan, 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：

中南大学湘雅二医院

Primary sponsor：

The Second Xiangya Hospital, Central South University

研究实施负责（组长）单位地址：

中国湖南省长沙市人民中路139号中南大学湘雅二医院

Primary sponsor's address：

139 Middle Renmin Road, Changsha, Hu'nan, 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)：	湖南省	市(区县)：	长沙市
Country：	China	Province：	Hu'nan	City：	Changsha
单位(医院)：	中南大学湘雅二医院	具体地址：	中国湖南省长沙市人民中路139号中南大学湘雅二医院
Institution hospital：	The Second Xiangya Hospital, Central South University,	Address：	139 Middle Renmin Road

经费或物资来源：

国家自然科学基金（81871057）

Source(s) of funding：

National Natural Science Foundation of China (NO.81871057）

研究疾病：

精神分裂症

Target disease：

schizophrenia

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

探索性研究/预试验

Study phase：

0

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

研究目的：

（1）揭示难治性精神分裂症脑结构和功能网络特异性神经影像学表征，及其动态变化模式。（2）揭示难治性精神分裂症遗传变异特征图谱。（3）结合影像学和遗传学方法，建立探究抗精神病药物疗效预测模型，实现难治性精神分裂症早期诊断。

Objectives of Study：

1. Reveal the specific neuroimaging characteristics of the brain structure and function network of treatment resistant schizophrenia, and its dynamic change pattern; 2. Reveal the genetic variation feature map of treatment resistant schizophrenia; 3. Combining imaging and genetic methods to establish a predictive model to explore the efficacy of antipsychotic drugs to achieve early diagnosis of treatment resistant schizophrenia.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

FES group:
1. DSM-IV-TR structured interview (SCID) was used, which met the diagnostic criteria of schizophrenia by DSM-IV-TR;
2. ill duration > 12 weeks, no more than 12 months;
3. Panss score>60;
4. Not taking any antipsychotic or antipsychotic for more than 14 days and not taking antipsychotic for nearly 1 week;
5. Han Nationality;
6. aged 18 to 40 years;
7. right handed.
Healthy control group:
1. The gender, age, and education level of the enrollment matched with the schizophrenia group;
2. age 18 to 40 years old;
3. right-handed;
4. No history of mental illness;
5. no mental disorder that meets the diagnostic criteria of DSM-IV axis 1 within two lines and three generations;
6. no contraindications to MRI scanning.
TRS group:
1. DSM-IV-TR structured interview (SCID) was used, which met the DSM-IV-TR symptom criteria for diagnosis of schizophrenia;
2. the course of disease was 1 to 5 years;
3. previous use of drugs other than clozapine After two antipsychotic drugs in sufficient quantities (>=600mg chlorpromazine equivalent dose) and a full course of treatment (>=6 weeks), the symptoms are not improved significantly, and there are still moderate or above mental symptoms, PANSS> 60 points;
4. there are moderate or above Dysfunction, with moderate or higher dysfunction, Social and Occupational Functioning Assessment Scale (SOFAS) score <60 points;
5. Han nationality;
6. aged 18-40 years old;
7. right-handed.
Non-TRS group:
1. DSM-IV-TR structured interview (SCID) was adopted, which met the DSM-IV-TR symptom criteria for diagnosis of schizophrenia;
2. the course of disease was 1 to 5 years;
3. previous use of drugs other than clozapine The antipsychotic drug treatment has a good effect, the symptoms are significantly improved and the duration is more than 6 months;
4. the mental symptoms score is mild or better, and each item of PANSS is scored within 3 points;
5. the dysfunction is not obvious or mild dysfunction, SOFAS Score> 70 points;
6. Han nationality;
7. age 18-40 years old;
8. right-handed.

排除标准：

首发精神分裂症组：
符合 DSM-IV 诊断标准的分裂情感障碍、双相障碍、精神发育迟滞、焦虑谱系障碍、毒品、酒精等精神活性物质所致精神病性障碍；有脑器质性疾病或颅脑损伤史；有酒精和药物依赖病史；超过 5 分钟以上的意识障碍史；甲状腺功能异常、糖尿病等内分泌疾病史；经检查血象、心、肝、肾功能严重异常者；妊娠期和哺乳妇女；磁共振检查禁忌者；曾使用氯氮平治疗者；曾使用电休克治疗者。
健康对照组：超过 5 分钟以上的意识障碍史；有脑器质性疾病或颅脑损伤史；有酒精和药物依赖病史；甲状腺功能异常、糖尿病等内分泌疾病史；经检查血象、心、肝、肾功能严重异常者；妊娠期和哺乳妇女；磁共振检查禁忌者。
难治性精神分裂症组：
符合 DSM-IV 诊断标准的分裂情感障碍、双相障碍、精神发育迟滞、焦虑谱系障碍、毒品、酒精等精神活性物质所致精神病性障碍；有脑器质性疾病或颅脑损伤史；有酒精和药物依赖病史；超过 5 分钟以上的意识障碍史；甲状腺功能异常、糖尿病等内分泌疾病史；经检查血象、心、肝、肾功能严重异常者；妊娠期和哺乳妇女。
非难治性精神分裂症组：
符合 DSM-IV 诊断标准的分裂情感障碍、双相障碍、精神发育迟滞、焦虑谱系障碍、毒品、酒精等精神活性物质所致精神病性障碍；有脑器质性疾病或颅脑损伤史；有酒精和药物依赖病史；超过 5 分钟以上的意识障碍史；甲状腺功能异常、糖尿病等内分泌疾病史；经检查血象、心、肝、肾功能严重异常者；妊娠期和哺乳妇女。

Exclusion criteria：

FES group:
1. schizoaffective disorder, bipolar disorder, mental retardation, anxiety spectrum disorder, drugs, alcohol and other psychoactive disorders that meet the diagnostic criteria of DSM-IV;
2. psychotic disorders caused by psychoactive substances such as drugs and alcohol;
3. History of brain injury;
4. history of alcohol and drug dependence;
5. history of consciousness disturbance for more than 5 minutes;
6. history of endocrine diseases such as thyroid function abnormality and diabetes;
7. people with severe abnormal blood picture, heart, liver, and kidney function after examination;
8. pregnant and lactating women; Those who are contraindicated in MRI examination;
9. those who have been treated with clozapine;
10. those who have been treated with electroconvulsive therapy.
Healthy control group:
1. a history of consciousness disturbance for more than 5 minutes;
2. a history of organic brain disease or head injury;
3. a history of alcohol and drug dependence;
4. a history of endocrine diseases such as thyroid dysfunction and diabetes;
5. blood, heart, liver, Patients with severely abnormal renal function;
6. pregnant women and lactating women;
7. those who are contraindicated in MRI examination.
TES group:
1. schizoaffective disorder, bipolar disorder, mental retardation, anxiety spectrum disorder, drugs, alcohol and other psychoactive disorders that meet the diagnostic criteria of DSM-IV psychotic disorders;
2. have brain organic diseases Or history of brain injury; history of alcohol and drug dependence;
3. history of consciousness disturbance for more than 5 minutes;
4. history of endocrine diseases such as abnormal thyroid function and diabetes;
5. people with severe abnormal blood picture, heart, liver, and kidney function after examination;
6. pregnancy and breastfeeding Women.
Non-TES group:
1. schizoaffective disorder, bipolar disorder, mental retardation, anxiety spectrum disorder, drugs, alcohol and other psychoactive disorders that meet the diagnostic criteria of DSM-IV; psychotic disorders caused by psychoactive substances such as drugs and alcohol;
2. with brain organic diseases Or history of brain injury; history of alcohol and drug dependence;
3. history of consciousness disturbance for more than 5 minutes;
4. history of endocrine diseases such as abnormal thyroid function and diabetes;
5. people with severe abnormal blood picture, heart, liver, and kidney function after examination;
6. pregnancy and breastfeeding Women.

研究实施时间：

Study execute time：

从 From 2020-08-14 00:00:00至 To 2024-08-14 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2020-08-14 00:00:00 至 To 2023-08-14 00:00:00

干预措施：

Interventions：

组别：	非难治性精神分裂症	样本量：	330
Group：	Non-Refractory schizophrenia	Sample size：	330
干预措施：	Nil	干预措施代码：
Intervention：	Nil	Intervention code：

组别：	难治性精神分裂症	样本量：	330
Group：	Refractory schizophrenia	Sample size：	330
干预措施：	Nil	干预措施代码：
Intervention：	Nil	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	湖南省	市(区县)：	长沙市
Country：	China	Province：	Hu'nan	City：	Changsha
单位(医院)：	中南大学湘雅二医院	单位级别：	三甲医院
Institution hospital：	The Second Xiangya Hospital, Central South University	Level of the institution：	Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：	量表评分	指标类型：	主要指标
Outcome：	Scale score	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	脑影像数据	指标类型：	主要指标
Outcome：	Brain imaging data	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	遗传药理学分析	指标类型：	主要指标
Outcome：	Genetic pharmacology analysis	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：

暂停或中断

Suspending

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	40	岁 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）：

非随机对照实验

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

No

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	N/A
Blinding：	N/A
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

是否共享原始数据： IPD sharing	否No
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）：	网络共享；时间：发表论文后；网址：http://h6world.cn
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Network sharing; time: after publication of the paper; website: http://h6world.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：	病例记录表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	(Case Record Form, CRF)
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2020-08-22 05:28:32