ChiCTR2400094625 版本V1.0 版本创建时间2024/12/25 11:42:37 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400094625 

最近更新日期：

Date of Last Refreshed on：

 2024-12-25 11:38:02 

注册时间：

Date of Registration：

 2024-12-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

抑郁症认知损害与内质网应激介导凋亡的相关机制研究

Public title：

Mechanisms related to cognitive impairment in depression and endoplasmic reticulum stress-mediated apoptosis

注册题目简写：

抑郁症认知损害与内质网应激介导凋亡的相关机制研究

English Acronym：

Mechanisms related to cognitive impairment in MDD and ERS-mediated apoptosis

研究课题的正式科学名称：

抑郁症认知损害与内质网应激介导凋亡的相关机制研究

Scientific title：

Mechanisms related to cognitive impairment in depression and endoplasmic reticulum stress-mediated apoptosis

研究课题代号(代码)：

Study subject ID：

 SKJP1320243970

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：

张晶 

研究负责人：

张晶 

Applicant：

Zhang Jing 

Study leader：

Zhang Jing 

申请注册联系人电话：

Applicant telephone：

 +86 157 9769 5482

研究负责人电话：

Study leader's
telephone：

+86 157 9769 5482

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：

 ZhangJ1080@163.com

研究负责人电子邮件：

Study leader's E-mail：

 ZhangJ1080@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 https://jxsjsby.cn/

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：

江西省南昌市青山湖区上访路43号 No.43 Shangfang Road, Qingshanhu District, Nanchang, Jiang xi

研究负责人通讯地址：

江西省南昌市青山湖区上访路43号 No.43 Shangfang Road, Qingshanhu District, Nanchang, Jiang xi

Applicant address：

No.43 Shangfang Road, Qingshanhu District, Nanchang, Jiang xi.

Study leader's address：

No.43 Shangfang Road, Qingshanhu District, Nanchang, Jiang xi.

申请注册联系人邮政编码：

Applicant postcode：

 330029

研究负责人邮政编码：

Study leader's postcode：

 330029

申请人所在单位：

江西省精神病院

Applicant's institution：

Jiangxi Mental Hospital

研究负责人所在单位：

江西省精神病院

Affiliation of the Leader：

Jiangxi Mental Hospital

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：

 (2024)医研伦审第(004)

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：

江西省精神病院（医学研究）伦理委员会

Name of the ethic committee：

Ethics Committee of Jiangxi Mental Hospital (Medical Research).

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-09-10 00:00:00

伦理委员会联系人：

占海燕

Contact Name of the ethic committee：

Zhan Haiyan

伦理委员会联系地址：

江西省南昌市青山湖区上访路43号

Contact Address of the ethic committee：

No.43 Shangfang Road, Qingshanhu District, Nanchang, Jiang xi.

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 150 7900 0802

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：

江西省精神病院

Primary sponsor：

Jiangxi Mental Hospital

研究实施负责（组长）单位地址：

江西省南昌市青山湖区上访路43号

Primary sponsor's address：

No.43 Shangfang Road, Qingshanhu District, Nanchang, Jiang xi

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江西

市(区县)：

南昌

Country：

China

Province：

Jiangxi

City：

Nanchang

单位(医院)：

江西省精神病院

具体地址：

江西省南昌市青山湖区上访路43号

Institution
hospital：

Jiangxi Mental Hospital

Address：

No.43 Shangfang Road, Qingshanhu District, Nanchang, Jiang xi

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

抑郁症  

Target disease：

Depression

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

研究设计：

病例对照研究 

Study design：

Case-Control study 

研究目的：

1.探讨抑郁症患者的认知损害特点、抑郁症患者外周血中内质网应激相关因子的变化和临床意义；为探索抑郁症的病理机制及基于此种机制的新药研究提供了可能途径。 2.探究内质网应激介导的细胞凋亡与抑郁症认知损害的相关性；助力于临床开发新的诊断工具。  

Objectives of Study：

1. Explore the characteristics of cognitive impairment in patients with depression, changes in endoplasmic reticulum stress-related factors in peripheral blood of patients with depression, and their clinical significance; This provides a possible pathway for exploring the pathological mechanism of depression and researching new drugs based on this mechanism. 2. Explore the correlation between endoplasmic reticulum stress-induced cell apoptosis and cognitive impairment in depression; Assist in the development of new diagnostic tools in clinical practice.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

选取2025年01月—2025年12月,来江西省精神病院门诊或住院就诊的、处于急性发作期的抑郁症患者共50例(MDD组), MDD组均以抑郁急性发作期入组,故亦标记为(MDD-A组),MDD-A组经临床治疗进入能够进入缓解恢复期的标记为(MDD-R组);选取年龄及性别相匹配健康人群50例(CON组)。 1.入组标准 1)MDD组: MDD组均以抑郁急性发作期入组,故即为(MDD-A组)。 ①符合《国际疾病与相关健康问题统计分类》第11版(ICD-11)中“抑郁障碍”的诊断标准;且病人均为首诊、未经过抗抑郁治疗,或者在参加研究前至少3个月停止服用任何抗抑郁药物。 ②由至少2名精神科医师评估汉密尔顿抑郁量表(HAMD-24)评分>20分; ③视力或矫正视力正常,无色盲或眼科其它疾病,无面部表情识别障碍,无言语交流困难,可以完成眼动实验; ④右利手,年龄在16至55岁之间,初中以上文化(具备实行MCCB的能力); ⑤患者或家属均知情并自愿参与实验、签署知情同意书; ⑥自愿参与并如实填写研究人员自制的一般情况及自杀意念、行为情况问询表。 2)拟MDD-A组经临床治疗后进入缓解恢复期(MDD-R组)的判定条件是:经治疗(大概为治疗后的4-6周),通过医生访谈、评估,HAMD-24评分≤20且减分率≥50%。 3)CON组:符合(HAMD-24)评分<8分,其余纳入标准和MDD组③④⑤⑥条相同

Inclusion criteria

Select a total of 50 patients with acute depression (MDD group) who visited the outpatient or inpatient department of Jiangxi Provincial Mental Hospital from January 2025 to December 2025 and were in the acute attack stage, The MDD group was enrolled in the acute depressive episode phase, hence also marked as the MDD-A group. The MDD-A group, which entered the remission and recovery phase after clinical treatment, was marked as the MDD-R group; Select 50 age and gender matched healthy individuals (CON group). 1. Inclusion criteria: 1.1. MDD group: The MDD group was enrolled during the acute phase of depression, hence it is referred to as the MDD-A group; (1).Meets the diagnostic criteria for "depressive disorder" in the 11th edition of the International Classification of Diseases and Related Health Problems (ICD-11); And all patients were first diagnosed, did not receive antidepressant treatment, or stopped taking any antidepressant medication at least 3 months before participating in the study; (2). Evaluate Hamilton Depression Rating Scale (HAMD-24) score>20 points by at least 2 psychiatrists; (3). Normal vision or corrected vision, no color blindness or other ophthalmic diseases, no facial expression recognition disorders, no difficulty in verbal communication, able to complete eye movement experiments; (4). Right handed, aged between 16 and 55, with a junior high school education or above (capable of implementing MCCB); (5).Patients or their families are informed and voluntarily participate in the experiment, and sign informed consent forms; (6).Voluntarily participate and truthfully fill out the general information and suicidal ideation/behavior inquiry form self-made by the researchers; 1.2. The criteria for entering the remission and recovery period (MDD-R group) after clinical treatment in the MDD-A group are: after treatment (approximately 4-6 weeks after treatment), through doctor interviews and evaluations, HAMD-24 score <= 20 and reduction rate >= 50%; 1.3. CON group: Meets the HAMD-24 score of<8 points, and the other inclusion criteria are the same as those of MDD group (3), (4), (5), and (6).

排除标准：

MDD组与CON组排除标准相同。 ①排除伴有脑器质性疾病、严重躯体疾病、精神活性物质依赖、应激相关障碍,以及继发于其他器质性疾病的抑郁问题患者; ②排除伴发精神科其他重性疾病(如精神分裂症、双相情感障碍等)及非自杀性自杀、人格障碍导致的自伤自杀患者,或严重兴奋激越伴有幻觉、妄想者,测验前服用过精神活性物质者; ③应存在高血压、糖尿病及其他器质性因素而无法耐受进行眼动测验、MCCB测验及抽血者; ④经精神科医生评估,患者抑郁性自杀/自伤意念强烈、行为冲动已致躯体严重损伤,无法或暂无法接受眼动及MCCB测试的患者; ⑤经精神科医生评估,患者既往虽诊断抑郁症,但近期病史存在“软双相”诊断倾向及可能。

Exclusion criteria：

The exclusion criteria for MDD group and CON group are the same. 1.Exclude patients with depression accompanied by brain organic diseases, severe physical illnesses, dependence on psychoactive substances, stress-related disorders, and secondary to other organic diseases; 2. Exclude patients with comorbidities of other serious psychiatric disorders (such as schizophrenia, bipolar disorder, etc.), non suicidal suicide, self injury and suicide caused by personality disorders, or severe excitement accompanied by hallucinations and delusions, as well as those who have taken psychoactive substances before the test; 3. Those who should have hypertension, diabetes and other organic factors and cannot tolerate eye movement test, MCCB test and blood drawing; 4. According to the assessment of a psychiatrist, patients with strong depressive suicidal/self injurious ideation, impulsive behavior that has caused severe physical damage, and are unable or temporarily unable to undergo eye tracking and MCCB testing; 5. According to the assessment of a psychiatrist, although the patient has been diagnosed with depression in the past, there is a tendency and possibility of a "soft biphasic" diagnosis in their recent medical history.

研究实施时间：

Study execute time：

从 From 2024-11-30 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-01-01 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：

正常对照组

样本量：

 50

Group：

Normal control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

抑郁组（抑郁急性发作组）---（抑郁缓解恢复期组）

样本量：

 50

Group：

MDD group (MDD-A group)---MDD-Rgroup

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江西 

市(区县)：

 南昌 

Country：

China

Province：

Jiangxi

City：

Nanchang

单位(医院)：

 江西省精神病院 

单位级别：

 三甲 

Institution
hospital：

Jiangxi Mental Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

汉密尔顿抑郁评分量表-24项版评分

指标类型：

主要指标

Outcome：

HAMD-24 rating

Type：

Primary indicator

测量时间点：

入组前；MDD-R组的判定

测量方法：

由至少2名精神科医师评估汉密尔顿抑郁量表（HAMD-24）评分，取平均值。

Measure time point of outcome：

Before joining the group;Determination of MDD-R group

Measure method：

Evaluate the Hamilton Depression Rating Scale (HAMD-24) score by at least 2 psychiatrists,taking the average value.

指标中文名：

注意偏向分数

指标类型：

主要指标

Outcome：

Pay attention to biased scores

Type：

Primary indicator

测量时间点：

入组后一周内；判定进入MDD-R组后一周内

测量方法：

使用由中国科学院心理研究所编制修订的中国化面孔情绪图片系统（CFAPS），制作测验程序，使用TX300眼动仪及Tobii Studio应用程序呈现测验程序、捕捉眼动数据。

Measure time point of outcome：

Within one week after joining the group;Within one week after entering the MDD-R group.

Measure method：

Using the Chinese Face Emotional Picture System (CFAPS) compiled and revised by the Institute of Psychology of the Chinese Academy of Sciences, the test program was made, and the TX300 eye tracker and Tobii Studio application program were used to present the test program and capture eye movement data

指标中文名：

MATRICS 共识认知成套测验评分

指标类型：

主要指标

Outcome：

MATRICS Consensus Battery rating

Type：

Primary indicator

测量时间点：

入组后一周内；判定进入MDD-R组后一周内

测量方法：

使用美国国立精神卫生研究院（NIMH）制定的精神分裂症（SCZ）认知功能成套测验改编的中文版，测量7个心理维度及9项分测验的认知功能领域进行检测。

Measure time point of outcome：

Within one week after joining the group;Within one week after entering the MDD-R group.

Measure method：

The Chinese version of the Schizophrenia (SCZ) Cognitive Function Test developed by the National Institute of Mental Health (NIMH) was used to measure 7 psychological dimensions and 9 sub-test cognitive function domains.

指标中文名：

外周血中GRP78、CHOP、Bax、BDNF的水平

指标类型：

主要指标

Outcome：

GRP78,CHOP, Bax and BDNF in the peripheral blood

Type：

Primary indicator

测量时间点：

收集足够的组内人数后一周内同时检测

测量方法：

使用酶联免疫吸附法(Elisa)，96孔Elisa试剂盒

Measure time point of outcome：

Collect sufficient group members and conduct simultaneous testing within one week

Measure method：

Using enzyme-linked immunosorbent assay (Elisa),96 well Elisa kit.

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 16 岁 years
最大 Max age 55 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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

None

Blinding：

None

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）：

无

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

None

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：

1.病例记录表（门诊/住院HIS电子病历系统提供相关信息） 2.电子采集和管理系统（药物/医嘱干预/实验结果信息来自LIS实验室及医嘱系统）病例记录表以及电子采集和管理系统。

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

1.Case Record Form (Outpatient/Inpatient HIS Electronic Medical Record System provides relevant information); 2. Electronic collection and management system (drug/medical order intervention/experimental result information comes from LIS laboratory and medical order system)

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：

  2024-12-25 11:38:02