今天是:2022-01-25 星期二

血清外泌体非编码RNA在青少年抑郁症中的临床应用价值
下载XML文档

注册号:

Registration number:

ChiCTR2100053830 

最近更新日期:

Date of Last Refreshed on:

2021-11-30 

注册时间:

Date of Registration:

2021-11-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

血清外泌体非编码RNA在青少年抑郁症中的临床应用价值 

Public title:

The Clinical Value of Serum Exosome Noncoding RNA in Adolescent Depression 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

血清外泌体非编码RNA在青少年抑郁症中的临床应用价值 

Scientific title:

The Clinical Value of Serum Exosome Noncoding RNA in Adolescent Depression 

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:

冉柳毅 

研究负责人:

冉柳毅 

Applicant:

Ran Liuyi 

Study leader:

Ran Liuyi 

申请注册联系人电话:

Applicant telephone:

17783490079 

研究负责人电话:

Study leader's telephone:

17783490079 

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:

ranliuyi@163.com 

研究负责人电子邮件:

Study leader's E-mail:

ranliuyi@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:

重庆市沙坪坝区大学城中路55号 

研究负责人通讯地址:

重庆市沙坪坝区大学城中路55号 

Applicant address:

Road 55,University Town Middle Road,Shapingba District,Chongqing,China 

Study leader's address:

Road 55,University Town Middle Road,Shapingba District,Chongqing,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:

重庆医科大学附属大学城医院 

Applicant's institution:

University City Hospital of Chongqing 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:

LL-202109 

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:

重庆医科大学附属大学城医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of University Town Hospital Affiliated to Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-05-28 

伦理委员会联系人:

王晓亮 

Contact Name of the ethic committee:

Wang Xiaoliang 

伦理委员会联系地址:

重庆市沙坪坝区大学城中路55号 

Contact Address of the ethic committee:

Road 55,University Town Middle Road,Shapingba District,Chongqing,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:

重庆医科大学附属大学城医院 

Primary sponsor:

University City Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市沙坪坝区大学城中路55号 

Primary sponsor's address:

Road 55,University Town Middle Road,Shapingba District,Chongqing,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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学附属大学城医院

具体地址:

重庆市沙坪坝区大学城中路55号

Institution
hospital:

University City Hospital of Chongqing Medical University

Address:

Road 55,University Town Middle Road,Shapingba District,Chongqing,China

经费或物资来源:

重庆市科卫联合医学科研项目 

Source(s) of funding:

Chongqing Science and Health Joint Medical Research Project 

研究疾病:

重性抑郁障碍 

Target disease:

Major depressive disorder 

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:

其它 

Study phase:

N/A 

研究目的:

①明确血清外泌体非编码RNA和青少年抑郁症的临床相关性; ②探索血清外泌体非编码RNA表达水平与青少年抑郁症诊断、治疗反应和疾病预后的关系,探寻相关分子在临床应用的可行性,明确其临床价值。 

Objectives of Study:

①To identify the clinical correlation between serum exosome non-coding RNA and adolescent depression; ②To explore the relationship between the expression level of serum exosome non-coding RNA and the diagnosis, treatment response and prognosis of adolescent depression, to explore the feasibility of related molecules in clinical application, and to clarify their clinical value. 

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:

抑郁症组入组标准: ①采用简明儿童少年国际神经精神访谈(Mini International Neuropsychiatric Interview for children and adolescents, MINI Kid)符合《美国精神障碍诊断与统计手册第五版》(DSM-Ⅴ)关于“重性抑郁障碍”的诊断标准; ②年龄13-18岁,汉族,小学及以上文化程度; ③儿童抑郁评定量表修订版≥40分,且32项轻躁狂症状清单<14分排除双相情感障碍; ④未经抗抑郁药物或心理或物理治疗;⑤患者本人及其法定监护人已签署本研究的知情同意书。 健康对照组入组标准: ①既往及当前无任何精神疾病; ②年龄13-18岁,汉族,小学及以上文化程度; ③患者本人和/或法定监护人自愿参加本研究,理解并签署书面知情同意书; 

Inclusion criteria

Criteria for inclusion in depression group: ① The Mini International Neuropsychiatric Interview for children and adolescents (MINIKid) was used to meet the diagnostic and statistical manual of mental disorders-5 Diagnostic Criteria for Major Depressive Disorder (DSM-V); ② Age 13-18 years old, Han nationality, primary school education or above; ③ Children's Depression Rating Scale-Revised ≥ 40 points and 32 hypomanic symptoms < 14 points excluded bipolar affective disorder; ④ Without medication or psychological or physical treatment; ⑤ The patient and his legal guardian have signed the informed consent of this study. Criteria for inclusion in healthy control group: ① no previous or current mental illness; ② Age 13-18 years old, Han nationality, primary school education or above; ③ Patients and/or legal guardians voluntarily participated in the study, understood and signed a written informed consent; 

排除标准:

抑郁症组排除标准: ①严重的心、肝、肾、内分泌、血液系统、肿瘤、自身免疫性等内科疾病; ②既往或当前的脑器质性疾病; ③其他严重精神障碍病史,包括精神分裂症、双相情感障碍、精神发育迟滞; ④既往或当前有物质依赖或滥用史; ⑤既往有氟西汀过敏史; ⑥既往有严重自杀未遂史,或目前存在高自杀风险者。 健康对照组排除标准: ①患有严重的或不稳定的躯体疾病的患者; ②既往或当前的脑器质性疾病; ③两系三代有精神疾病家族史; 

Exclusion criteria:

Exclusion criteria of depression group: ① serious heart, liver, kidney, endocrine, blood system, tumor, autoimmune and other medical diseases; ② previous or current brain organic diseases; ③ History of other severe mental disorders, including schizophrenia, bipolar affective disorder and mental retardation; ④ Past or current history of substance dependence or abuse; ⑤ a history of allergy to fluoxetine; ⑥ Those who had a history of serious suicide attempt or had a high risk of suicide at present. Exclusion criteria of healthy control group: ① Patients with severe or unstable physical diseases; ② previous or current brain organic diseases; ③ Family history of mental illness in two lines and three generations; 

研究实施时间:

Study execute time:

From2022-01-01To 2023-12-31 

征募观察对象时间:

Recruiting time:

From2022-01-08To 2023-06-30 

干预措施:

Interventions:

组别:

药物治疗组

样本量:

60

Group:

Drug treatment group

Sample size:

干预措施:

氟西汀

干预措施代码:

Intervention:

Fluoxetine

Intervention code:

组别:

药物联合心理治疗组

样本量:

60

Group:

Drug combined with psychotherapy group

Sample size:

干预措施:

氟西汀联合认知行为心理治疗

干预措施代码:

Intervention:

Fluoxetine combined with cognitive behavior psychotherapy

Intervention code:

组别:

健康对照组

样本量:

80

Group:

Healthy control group

Sample size:

干预措施:

干预措施代码:

Intervention:

nothing

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆市 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属大学城医院 

单位级别:

三级医院 

Institution
hospital:

University City Hospital of Chongqing Medical University  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

儿童抑郁评定量表修订版

指标类型:

主要指标 

Outcome:

Revised Depression Rating Scale for Children

Type:

Primary indicator 

测量时间点:

基线、2周、8周、12周、24周、48周

测量方法:

Measure time point of outcome:

Baseline, 2 weeks, 8 weeks, 12 weeks, 24 weeks, 48 week

Measure method:

指标中文名:

汉密尔顿抑郁量表

指标类型:

主要指标 

Outcome:

Hamilton Depression Scale

Type:

Primary indicator 

测量时间点:

基线、2周、8周、12周、24周、48周

测量方法:

Measure time point of outcome:

Baseline, 2 weeks, 8 weeks, 12 weeks, 24 weeks, 48 week

Measure method:

指标中文名:

儿童大体评定量表

指标类型:

次要指标 

Outcome:

Global Assessment Scale for Children

Type:

Secondary indicator 

测量时间点:

基线、2周、8周、12周、24周、48周

测量方法:

Measure time point of outcome:

Baseline, 2 weeks, 8 weeks, 12 weeks, 24 weeks, 48 week

Measure method:

指标中文名:

席汉失能量表

指标类型:

次要指标 

Outcome:

Sheehan Disability Scale

Type:

Secondary indicator 

测量时间点:

基线、2周、8周、12周、24周、48周

测量方法:

Measure time point of outcome:

Baseline, 2 weeks, 8 weeks, 12 weeks, 24 weeks, 48 week

Measure method:

指标中文名:

儿童期虐待问卷

指标类型:

次要指标 

Outcome:

Child Abuse Questionnaire

Type:

Secondary indicator 

测量时间点:

基线

测量方法:

Measure time point of outcome:

Baseline

Measure method:

指标中文名:

青少年生活事件量表

指标类型:

次要指标 

Outcome:

Adolescent Self-Rating Life Events Scale

Type:

Secondary indicator 

测量时间点:

基线

测量方法:

Measure time point of outcome:

Baseline

Measure method:

指标中文名:

心理弹性量表

指标类型:

次要指标 

Outcome:

Resilience Scale

Type:

Secondary indicator 

测量时间点:

基线、2周、8周、12周、24周、48周

测量方法:

Measure time point of outcome:

Baseline, 2 weeks, 8 weeks, 12 weeks, 24 weeks, 48 week

Measure method:

指标中文名:

大五人格

指标类型:

次要指标 

Outcome:

Big Five Personality

Type:

Secondary indicator 

测量时间点:

基线

测量方法:

Measure time point of outcome:

Baseline

Measure method:

指标中文名:

冲动行为量表

指标类型:

次要指标 

Outcome:

Impulsive Behavior Scale

Type:

Secondary indicator 

测量时间点:

基线

测量方法:

Measure time point of outcome:

Baseline

Measure method:

指标中文名:

9项患者健康问卷

指标类型:

主要指标 

Outcome:

Patient Health Questionaire - 9 items

Type:

Primary indicator 

测量时间点:

基线、2周、8周、12周、24周、48周

测量方法:

Measure time point of outcome:

Baseline, 2 weeks, 8 weeks, 12 weeks, 24 weeks, 48 week

Measure method:

指标中文名:

UKU副作用量表

指标类型:

副作用指标 

Outcome:

UKU Side Effect Rating Scale

Type:

Adverse events 

测量时间点:

2周、8周、12周、24周、48周

测量方法:

Measure time point of outcome:

2 weeks, 8 weeks, 12 weeks, 24 weeks, 48 week

Measure method:

指标中文名:

外泌体非编码RNA(非编码小RNA、长链非编码RNA、环状RNA)

指标类型:

附加指标 

Outcome:

Exosome non-coding RNA(miRNA/lncRNA/circRNA)

Type:

Additional indicator 

测量时间点:

基线、8周、48周

测量方法:

高通量测序、定量PCR

Measure time point of outcome:

baseline、week 8、week 48

Measure method:

High-throughput sequencing, quantitative PCR

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 13 years
最大 Max age 18 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):

N/A

盲法:

不适用

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

N/A

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

N/A

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:

数据采集和管理先由研究者和量表评分员将访视期间的数据准确完整的记录在CRF表中,由质量控制人员定期检查,经核实确认无误后,再录入EDC系统,同时保证能在原始病历中进行溯源。

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

For data collection and management, the researcher and the scale rater shall record the data accurately and completely in the CRF form during the interview, and the data shall be checked by the quality control personnel on a regular basis, and shall be entered into the EDC system after being verified to be correct. Meanwhile, it is ensured that the data can be traced back to the source in the original medical records.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2021-11-30
返回列表