ChiCTR2600126176 版本V1.0 版本创建时间2026/06/04 16:35:54 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：

 ChiCTR2600126176 

最近更新日期：

Date of Last Refreshed on：

 2026-06-04 16:35:34 

注册时间：

Date of Registration：

 2026-06-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

肠-脑轴与类固醇激素在女性抑郁症的交互作用机制及其潜在分子标志物研究

Public title：

Research on the Interaction Mechanism between the Gut-Brain Axis and Steroid Hormones in Female Depression and Its Potential Molecular Markers.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

肠-脑轴与类固醇激素在女性抑郁症的交互作用机制及其潜在分子标志物研究

Scientific title：

Research on the Interaction Mechanism between the Gut-Brain Axis and Steroid Hormones in Female Depression and Its Potential Molecular Markers.

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：

潘俊希 

研究负责人：

潘俊希 

Applicant：

Pan Junxi 

Study leader：

Pan Junxi 

申请注册联系人电话：

Applicant telephone：

 +86 871 65324888

研究负责人电话：

Study leader's
telephone：

+86 871 65324888

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：

 panjunxi@139.com

研究负责人电子邮件：

Study leader's E-mail：

 panjunxi@139.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：

中国云南省昆明市五华区西昌路295号

研究负责人通讯地址：

中国云南省昆明市五华区西昌路295号

Applicant address：

295 Xichang Road, Wuhua District, Kunming, Yunnan, China

Study leader's address：

295 Xichang Road, Wuhua District, Kunming, Yunnan, 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：

昆明医科大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Kunming Medical University

研究负责人所在单位：

昆明医科大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Kunming 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：

 （2026）伦审L第89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：

昆明医科大学第一附属医院伦理委员会

Name of the ethic committee：

Ethics committee of First Affiliated Hospital of Kunming Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-03-10 00:00:00

伦理委员会联系人：

王婷

Contact Name of the ethic committee：

Wang Ting

伦理委员会联系地址：

中国云南省昆明市五华区西昌路295号

Contact Address of the ethic committee：

295 Xichang Road, Wuhua District, Kunming, Yunnan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 871 65328584

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 KYFYYEC@163.com

研究实施负责（组长）单位：

昆明医科大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Kunming Medical University

研究实施负责（组长）单位地址：

中国云南省昆明市五华区西昌路295号

Primary sponsor's address：

295 Xichang Road, Wuhua District, Kunming, Yunnan, 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)：

云南

市(区县)：

Country：

China

Province：

Yunnan

City：

单位(医院)：

昆明医科大学第一附属医院

具体地址：

中国云南省昆明市五华区西昌路295号

Institution
hospital：

The First Affiliated Hospital of Kunming Medical University

Address：

295 Xichang Road, Wuhua District, Kunming, Yunnan, China

经费或物资来源：

云南省高层次卫生健康技术人才培养专项

Source(s) of funding：

Yunnan Provincial High-Level Health Technology Talent Training Program

研究疾病：

抑郁症  

Target disease：

Major Depressive Disorder（MDD）

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：

本研究旨在充分利用患者和健康人群剩余血液样本和粪便样本，系统性地探究内源性类固醇激素、性激素、脂质组学、炎症因子以及肠道微生物组在抑郁症病理生理过程中的相互作用及其临床意义并系统对比其性别差异及女性不同生理阶段的特异性。研究的核心目的在于，通过高灵敏度的分析技术，定量检测抑郁症患者与健康对照个体血浆中类固醇激素、性激素、脂质组学以IL-6、TNF-α、CRP等关键炎症因子的水平，并同步分析其粪便样本中的肠道微生物组结构与功能，构建包含?“神经-内分泌-免疫-肠道菌群”?多维度的整合生物标志物谱系。我们拟重点阐明“下丘脑-垂体-肾上腺轴（HPA轴）”功能失调（表现为类固醇激素失衡）、“免疫系统持续激活”（表现为炎症因子水平升高）与“肠-脑轴功能紊乱”之间的内在关联，并进一步分析此类神经内分泌-免疫交叉对话在不同性别及不同抑郁临床亚型患者中的特异性表现。最终目标是为理解抑郁症的病理机制及生物标志物研究提供数据支撑。  

Objectives of Study：

This study aims to systematically investigate the interactions and clinical significance of endogenous steroid hormones, sex hormones, lipidomics, inflammatory factors, and the gut microbiome in the pathophysiological process of depression, by making full use of residual blood and stool samples from patients and healthy individuals. A key objective is to systematically compare gender differences and specificities across different physiological stages in women. The core purpose is to quantitatively detect the levels of steroid hormones, sex hormones, lipidomics, and key inflammatory factors such as IL-6, TNF-α, and CRP in the plasma of depressed patients and healthy controls using highly sensitive analytical techniques. Concurrently, we will analyze the structure and function of the gut microbiome in their stool samples. This will enable us to construct a multidimensional integrated biomarker profile encompassing the "neuro-endocrine-immune-gut microbiota" axis. We aim to elucidate the intrinsic links among hypothalamic-pituitary-adrenal (HPA) axis dysfunction (manifested as steroid hormone imbalance), persistent immune system activation (reflected by elevated inflammatory factors), and dysregulation of the gut-brain axis. Furthermore, we will analyze the specific manifestations of this neuroendocrine-immune crosstalk in different genders and various clinical subtypes of depression. The ultimate goal is to provide data to support the understanding of the pathological mechanism

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.观察组（需同时满足下列7条）：（1）年龄：≥12岁的门诊或住院患者，性别不限； （2）符合《神障碍诊断与统计手册（第五版）》诊断标准的抑郁症患，首发或复发均可； （3）筛选期和基线期汉密尔顿抑郁量表（HamiltonDepressionScale ，HAMD- 17）评分≥14； （4）样本量充足：剩余血清/血浆/全血体积 ≥ 500μL ，剩余粪便样本量≥0.5g，以满足后续检测需求； （5）样本信息完整，具有临床基本信息（如年龄、性别、初步诊断、抗抑郁药使用情况等）； （6）样本质量合格：无严重溶血、脂血、黄疸或污染。 2.健康对照组（需同时满足下列4条）：（1）年龄：≥12岁的门诊或住院患者，性别不限； （2）既往体健，无心血管、呼吸、消化、肾脏、内分泌、血液等系统躯体疾病； （3）既往无精神障碍病史； （4）基础临床检验（如血常规、肝功能、肾功能等）指标处于正常参考值范围内，或经研究医生判断无临床显著意义。

Inclusion criteria

1.Observation Group (all 7 criteria must be met simultaneously) (1)Age: Outpatients or inpatients aged 12 years or older, with no restriction on gender. (2)Diagnosed with depression in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), including first-onset and recurrent cases. (3)The score of the 17-item Hamilton Depression Rating Scale (HAMD-17) was >= 14 at the screening and baseline visits. (4)Sufficient sample volume: Remaining serum/plasma/whole blood >=500 μL; remaining stool sample >= 0.5 g, to meet the requirements for subsequent testing. (5)Complete sample information, including basic clinical data (e.g., age, gender, primary diagnosis, use of antidepressants, etc.). (6)Qualified sample quality: No severe hemolysis, lipemia, jaundice or contamination. 2.Healthy Control Group (all 4 criteria must be met simultaneously) (1)Age: Outpatients or inpatients aged 12 years or older, with no restriction on gender. (2)Generally healthy with no history of somatic diseases involving the cardiovascular, respiratory, digestive, renal, endocrine, hematological or other systems. (3)No prior history of mental disorders. (4)Routine clinical laboratory tests (e.g., blood routine, liver function, renal function, etc.) are within the normal reference ranges, or deemed to have no clinically significant abnormalities by the investigators.

排除标准：

1.观察组（符合下列任意1条即排除）：（1） 目前或既往患有符合除抑郁障碍之外的其他主要精神障碍诊断，如神经发育障碍、神经认知障碍、精神分裂症和其他精神病性障碍、双相情 感障碍、强迫障碍、惊恐障碍、创伤后应激障碍、酒精或药物依赖或滥用者、人格障碍等 ; （2）继发于某种全身性疾病或某种神经系统疾病所致的器质性精神障碍的抑郁发作，如甲状腺功能减退引起的抑郁； （3）伴有严重的或不稳定的心血管、呼吸、肝脏、肾脏、内分泌、血液系统或其他系统疾病，研究者认为不适合入组本项研究； （4）筛选期或基线期研究者认为患者体格检查、实验室检查异常且判定有明显临床意义的； （5）在筛选前 3 个 月接 受 过 系 统 性 改 良 电抽搐 治疗 (Modified Electric Convulsive Therapy ， MECT) 或 经 颅 磁 刺 激 治 疗 （ Transcranial Magnetic Stimulation ，TMS) 、深部脑刺激治疗（Deep Brain Stimulation ，DBS) 、迷走神经刺激治疗（Vagus Nerve Stimulation ，VNS)； （6）妊娠期、哺乳期女性 ，或育龄期女性筛选期血绒毛膜促性腺激素(Human Chorionic Gonadotophin ，HCG)/尿 HCG 检查结果阳性；或试验期间具有生殖潜力的男性或育龄期女性无法采取有效避孕措施；或计划在试验开始后的3个月内受（授）孕； （7）筛选前3个月参与过干预性临床试验； （8）存在任何其他经研究者判断可能干扰研究结果评估的情况； 2.健康对照组（符合下列任意1条即排除）：（1）现患有精神类疾病； （2）意识障碍史，精神分裂症、双相情感障碍、抑郁障碍或人格改变等精神疾病史； （3）家族遗传性疾病史； （4）严重躯体疾病，例如内分泌系统疾病及心脑血管类疾病者； （5）酒精/药物依赖史； （6）妊娠期、哺乳期女性； （7）血液样本出现严重溶血、脂血或保存不当等情况，不符合样本质量要求； （8）存在任何其他经研究者判断可能干扰研究结果评估的情况。

Exclusion criteria：

1.Exclusion Criteria for Observation Group (Any of the following items will lead to exclusion) (1)Current or prior diagnosis of major mental disorders other than depressive disorder, including neurodevelopmental disorders, neurocognitive disorders, schizophrenia and other psychotic disorders, bipolar affective disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, alcohol or drug dependence/abuse, personality disorders, etc. (2)Depressive episodes secondary to organic mental disorders caused by systemic diseases or neurological diseases (e.g., depression induced by hypothyroidism). (3)Presence of severe or unstable diseases of the cardiovascular, respiratory, hepatic, renal, endocrine, hematological or other systems, who are considered ineligible for enrollment by the investigators. (4)Abnormal physical examination or laboratory test findings with obvious clinical significance as judged by the investigators at the screening or baseline visit. (5)Received modified electric convulsive therapy (MECT), transcranial magnetic stimulation (TMS), deep brain stimulation (DBS) or vagus nerve stimulation (VNS) within 3 months prior to screening. (6)Pregnant or lactating females; females of childbearing potential with positive serum or urine human chorionic gonadotropin (HCG) test at screening; males with reproductive potential or females of childbearing potential who are unable to use effective contraception throughout the study; or those who plan to conceive or father a child within 3 months after study initiation. (7)Participation in any interventional clinical trial within 3 months prior to screening. (8)Any other conditions that may interfere with the evaluation of study outcomes, as determined by the investigators. 2.Exclusion Criteria for Healthy Control Group(Subjects meeting any of the following items shall be excluded) (1)Currently suffering from any mental disorder. (2)History of consciousness disturbance, schizophrenia, bipolar affective disorder, depressive disorder, personality change or other psychiatric diseases. (3)History of hereditary familial diseases. (4)Presence of severe somatic diseases, including endocrine diseases, cardiovascular and cerebrovascular diseases, etc. (5)History of alcohol or drug dependence. (6)Pregnant or lactating females. (7)Blood samples with severe hemolysis, lipemia, improper storage or other defects that fail to meet sample quality requirements. (8)Any other conditions deemed by the investigators to potentially interfere with the evaluation of study results.

研究实施时间：

Study execute time：

从 From 2026-06-10 00:00:00至 To 2027-12-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-10 00:00:00 至 To 2027-12-01 00:00:00

干预措施：

Interventions：

组别：

观察组（抑郁组）

样本量：

 300

Group：

Observation group (Depression group)

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

对照组（健康组）

样本量：

 200

Group：

Control group (Healthy control group)

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)：

 云南 

市(区县)：

  

Country：

China

Province：

Yunnan

City：

单位(医院)：

 昆明医科大学第一附属医院 

单位级别：

 三级甲等 

Institution
hospital：

The First Affiliated Hospital of Kunming Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

代谢相关指标（血脂）

指标类型：

次要指标

Outcome：

Metabolic indicators (blood lipids)

Type：

Secondary indicator

测量时间点：

入组当日清晨空腹，基线一次性测量

测量方法：

采集清晨空腹静脉血，使用全自动生化分析仪检测总胆固醇、甘油三酯、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇。

Measure time point of outcome：

Baseline, once at enrollment, in the early morning on an empty stomach

Measure method：

Fasting venous blood was collected in the early morning, and total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol were measured using an automatic biochemical analyzer.

指标中文名：

HAMD-17 抑郁严重程度评分

指标类型：

主要指标

Outcome：

HAMD-17 Depression Severity Score

Type：

Primary indicator

测量时间点：

入组当日（基线）一次性测量

测量方法：

采用 17 项汉密尔顿抑郁量表（HAMD-17），由经过统一培训并通过一致性考核的精神科医师对受试者进行结构化访谈，根据近 1 周的症状表现逐项评分，总分范围 0–52 分。

Measure time point of outcome：

Baseline (single measurement at enrollment)

Measure method：

The 17-item Hamilton Depression Rating Scale (HAMD-17) was used. Psychiatrists who had received standardized training and passed consistency assessments conducted structured interviews with subjects, and rated each item based on symptomatic manifestations over the previous week, with a total score ranging from 0 to 52.

指标中文名：

免疫炎症指标

指标类型：

次要指标

Outcome：

Immune and inflammatory indicators

Type：

Secondary indicator

测量时间点：

入组当日清晨空腹，基线一次性采集测量

测量方法：

采集清晨空腹静脉血，采用酶联免疫吸附试验（ELISA）或流式液相多重蛋白定量技术（CBA）进行定量检测，严格按照试剂盒说明书操作。

Measure time point of outcome：

Baseline, once at enrollment, in the early morning on an empty stomach

Measure method：

Fasting venous blood samples were collected in the early morning. Quantitative detection was performed using enzyme-linked immunosorbent assay (ELISA) or cytometric bead array (CBA), with all procedures strictly conducted in accordance with the kit instructions.

指标中文名：

神经内分泌指标（HPA 轴与性激素）

指标类型：

次要指标

Outcome：

Neuroendocrine indicators (HPA axis and sex hormones)

Type：

Secondary indicator

测量时间点：

入组当日清晨空腹，基线一次性采集测量

测量方法：

采集受试者入组当日清晨空腹静脉血，采用 电化学发光免疫分析法（ECLIA）或酶联免疫吸附试验（ELISA） 严格按照试剂盒说明书进行检测，所有样本统一批次检测以减少批间误差。

Measure time point of outcome：

Baseline, once at enrollment, in the early morning on an empty stomach

Measure method：

Fasting venous blood samples are collected from subjects in the early morning at enrollment. Neuroendocrine indicators are measured by electrochemiluminescence immunoassay (ECLIA) or enzyme-linked immunosorbent assay (ELISA)strictly following the kit instructions. All samples are tested in the same batch to minimize inter-assay variation.

指标中文名：

肠道微生物组指标

指标类型：

次要指标

Outcome：

Gut microbiome indicators

Type：

Secondary indicator

测量时间点：

入组当日一次性采集新鲜粪便样本

测量方法：

采集受试者新鲜粪便标本，采用 16S rRNA 基因高通量测序（V3?V4 区）进行测序，经生物信息学分析获得菌群多样性及关键物种丰度。

Measure time point of outcome：

Once at enrollment, fresh fecal samples are collected

Measure method：

Fresh fecal samples are collected from subjects and sequenced using high?throughput 16S rRNA gene sequencing (V3?V4 region). Microbiota diversity and key species abundance are obtained through bioinformatics analysis.

指标中文名：

抑郁症患病状态

指标类型：

主要指标

Outcome：

Depression status

Type：

Primary indicator

测量时间点：

入组当日（基线）一次性确认

测量方法：

抑郁症患病状态依据《精神疾病诊断与统计手册第五版（DSM-5）》及《国际疾病分类第十版（ICD-10）》抑郁障碍诊断标准，由两名具有中级及以上职称的精神科医师独立复核确认，意见不一致时由主任医师进行最终判定。

Measure time point of outcome：

Baseline (Day 0, confirmed once at enrollment)

Measure method：

Depression status is determined according to the diagnostic criteria for depressive disorders in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) and the International Classification of Diseases, 10th Revision (ICD-10), independently reviewed and confirmed by two psychiatrists with intermediate or higher professional titles. Discrepancies are resolved by a chief psychiatrist.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 12 岁 years
最大 Max age 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：

无

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.所有受试者的原始数据（包括人口学资料、临床信息、量表评分、实验室检测结果等）均由研究人员按统一标准记录在纸质 / 电子 CRF 中，确保数据真实、完整、可溯源。CRF 填写遵循 “谁记录、谁负责” 原则，修改需签名并注明日期，不得涂改原始记录； 2.建立专用电子数据采集系统，由专人将 CRF 中的数据录入系统，实行双人双录入、双核对机制，以降低录入误差。系统设置数据逻辑核查规则（如范围检查、一致性检查、缺失值提示），自动识别并提示异常数据，由研究人员核实修正。

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

Here’s the professional English translation, formatted to match your original numbered list:1. All raw data from subjects (including demographic information, clinical data, scale scores, laboratory test results, etc.) are recorded by research staff in paper or electronic Case Record Forms (CRFs) according to unified standards to ensure the authenticity, completeness, and traceability of the data. CRF entries follow the principle of "whoever records is responsible"; any corrections must be signed and dated, and the original records shall not be altered.2. A dedicated Electronic Data Capture (EDC) system is established. Data from CRFs are entered into the system by designated personnel using a double-data entry and double-verification mechanism to minimize entry errors. The system is configured with data validation rules (e.g., range checks, consistency checks, missing value alerts) to automatically identify and flag abnormal data, which are then verified and corrected by the research team.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-06-04 16:35:34