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：	ChiCTR2500115157
最近更新日期： Date of Last Refreshed on：	2025-12-23 11:16:33
注册时间： Date of Registration：	2025-12-23 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	丙泊酚优化艾司氯胺酮在难治性抑郁中的快速抗抑郁作用
Public title：	Propofol Optimizes the Rapid Antidepressant Effects of Esketamine in Treatment-Resistant Depression
注册题目简写：
English Acronym：
研究课题的正式科学名称：	丙泊酚优化艾司氯胺酮在难治性抑郁中的快速抗抑郁作用
Scientific title：	Propofol Optimizes the Rapid Antidepressant Effects of Esketamine in Treatment-Resistant 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：	戴家宝	研究负责人：	陆燕丰
Applicant：	Dai Jiabao	Study leader：	Lu Yanfeng
申请注册联系人电话： Applicant telephone：	+86 135 8535 7393	研究负责人电话： Study leader's telephone：	+86 135 8535 7393
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：	2779124616@qq.com	研究负责人电子邮件： Study leader's E-mail：	luyanfeng367@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：	江苏省常州市武进区滆湖中路68号	研究负责人通讯地址：	江苏省常州市武进区滆湖中路68号
Applicant address：	No. 68, Ge Lake Middle Road, Wujin District, Changzhou City, Jiangsu Province	Study leader's address：	No. 68, Ge Lake Middle Road, Wujin District, Changzhou City, Jiangsu Province
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：	常州市第二人民医院
Applicant's institution：	Changzhou NO.2 People's Hospital
研究负责人所在单位：	常州市第二人民医院
Affiliation of the Leader：	Changzhou NO.2 People's 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]YLJSA155	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：	常州市第二人民医院伦理委员会
Name of the ethic committee：	The Ethics Committee of Changzhou NO.2 People's Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2025-01-17 00:00:00
伦理委员会联系人：	李辰凯
Contact Name of the ethic committee：	Li Chenkai
伦理委员会联系地址：	江苏省常州市武进区滆湖中路68号
Contact Address of the ethic committee：	No. 68, Ge Lake Middle Road, Wujin District, Changzhou City, Jiangsu Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 519 8108 7655	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：

常州市第二人民医院

Primary sponsor：

Changzhou NO.2 People's Hospital

研究实施负责（组长）单位地址：

江苏省常州市武进区滆湖中路68号

Primary sponsor's address：

No. 68, Ge Lake Middle Road, Wujin District, Changzhou City, Jiangsu Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	江苏省	市(区县)：	武进区
Country：	China	Province：	Jiangsu	City：	Wujin
单位(医院)：	常州市第二人民医院	具体地址：	江苏省常州市武进区滆湖中路68号
Institution hospital：	Changzhou NO.2 People's Hospital	Address：	No. 68, Ge Lake Middle Road, Wujin District, Changzhou City, Jiangsu Province

经费或物资来源：

自筹

Source(s) of funding：

self-financing

研究疾病：

难治性抑郁

Target disease：

treatment-resistant depression

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

上市后药物

Study phase：

4

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

探究丙泊酚在减少艾司氯胺酮快速抗抑郁不良反应的可行性，并研究其是否影响艾司氯胺酮的抗抑郁疗效

Objectives of Study：

To explore the feasibility of using propofol in reducing the adverse reactions of rapid antidepressant effects of esketamine, and to investigate whether it affects the antidepressant efficacy of esketamine

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

排除标准：

1.患有符合DSM-5诊断标准的其他重性精神障碍，包括精神分裂症、分裂情感障碍、双相障碍等; 2.严重躯体或脑器质性疾病史，颅脑外伤史及癫痫病史; 3.药物、酒精或其他精神活性物质滥用史; 4.既往麻醉剂过敏史; 5.处于妊娠或哺乳期妇女或计划妊娠者; 6.研究者认为不宜纳入的其他情况。

Exclusion criteria：

1. Suffering from other severe mental disorders that meet the diagnostic criteria of DSM-5, including schizophrenia, schizoaffective disorder, bipolar disorder, etc.; 2. History of severe physical or brain organic diseases, history of head trauma and epilepsy; 3. History of drug, alcohol or other psychoactive substance abuse; 4. History of previous anesthetic drug allergy; 5. Pregnant or lactating women or those planning to get pregnant; 6. Other conditions that the researcher deems inappropriate for inclusion.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2026-11-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-01-01 00:00:00 至 To 2026-11-30 00:00:00

干预措施：

Interventions：

组别：	对照组	样本量：	68
Group：	control group	Sample size：	68
干预措施：	外周静脉泵注艾司氯胺酮（艾司氯胺酮采用亚麻醉剂量0.2mg/kg）40min	干预措施代码：
Intervention：	Peripheral venous infusion of esketamine (with an anesthetic dose of 0.2mg/kg) for 40 minutes	Intervention code：

组别：	优化治疗组	样本量：	68
Group：	Optimized treatment group	Sample size：	68
干预措施：	外周静脉泵注艾司氯胺酮（艾司氯胺酮采用亚麻醉剂量0.2mg/kg）40min，然后予以丙泊酚2-4mg/kg静脉推注让患者脑电缓慢进入镇静状态，维持5-10min后停药	干预措施代码：
Intervention：	Peripheral intravenous infusion of esketamine (with an anesthetic dose of 0.2mg/kg) was administered for 40 minutes. Then, propofol was intravenously injected at a rate of 2-4mg/kg to slowly induce a sedative state in the patient's brain waves, and this process was maintained for 5-10 minutes before the drug was discontinued.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	江苏省	市(区县)：	武进区
Country：	China	Province：	Jiangsu	City：	Wujin
单位(医院)：	常州市第二人民医院	单位级别：	三甲
Institution hospital：	Changzhou NO.2 People's Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	蒙哥马利抑郁评定量表	指标类型：	主要指标
Outcome：	Montgomery–Asberg Depression Rating Scale	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	分离状态量表	指标类型：	主要指标
Outcome：	Separation Status Scale	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	血压	指标类型：	次要指标
Outcome：	blood pressure	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	心率	指标类型：	次要指标
Outcome：	heart rate	Type：	Secondary 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：	无	组织：
Sample Name：	none	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	18	岁 years
最大 Max age	60	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）：

随机数字表法

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

Random number table method

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：	本研究为单盲设计，即受试者知晓自身分组，但负责随访评估的研究人员对具体分组不知情。
Blinding：	This study was designed as a single-blind trial, meaning that the participants were aware of their group assignment, but the researchers responsible for follow-up
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）：	不
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）数据记录的范围试验数据应包括原始病历/研究病历和、已签名的知情同意书、执行临床试验要求的各种检查和步骤(实验室样本、X线检查、心电图等)的检查日期和结果、受试者治疗前后抑郁状况、生活质量评估记录表、任何不良事件和研究过程中的问题的记录、严重不良事件的报告记录等涉及临床试验的所有数据。（2）每份原始资料上应有对应受试者的信息，并由完成记录人员签名、注明日期。（3）数据转抄原始病历/研究病历中的数据和各种实验室数据均应正确转抄。为保护受试者隐私，CRF上不应出现受试者的姓名。（4）数据保存试验数据应按照GCP的要求完整保存至临床试验终止后至少五年或按照相关约定延长保存时间（5）负责专业科室项目资料(国家食品药品监督管理总局及伦理批件、研究者手册、试验方案、知情同意书、研究病历、CRF、受试者服药记录或试验用器械使用记录等)的保存与管理，每项临床试验的项目资料单独立卷保存。（6）负责临床试验记录文件(知情同意书、研究病历、CRF、受试者服药日记卡等)的领取、分发、回收和保存。分发和回收的临床试验记录文件必须在科室资料登记本上详细记录。（7）负责在所有受试者试验观察结束后收回临床试验记录文件，交给主要研究者审核，并及时交给机构办公室复审后存入机构档案室。（8）临床试验结束后，负责将本项目资料及相关文件交给机构档案管理员，验收签字后由机构档案室保管。（9）未经科室负责人主要研究者和机构办公室许可，临床试验文件一律不得外借。（10）接受申办者/CRO派遣的监查员或稽查员的监查、稽查及药品监督管理部门的稽查和视察，以及机构质量管理人员和本专业项目质控员的检查，确保临床试验质量。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	(1) The range of data recorded should include original medical records/research medical records, signed informed consent forms, various examinations and procedures required for conducting the clinical trial (such as laboratory samples, X-ray examinations, electrocardiograms, etc.) with the dates and results of the examinations, the depression status of the subjects before and after treatment, quality of life assessment records, any adverse events and problems during the research process, and reports of serious adverse events, etc., all data related to the clinical trial. (2) Each original document should have corresponding information of the subject and be signed and dated by the person who completed the record. (3) The data copied from the original medical records/research medical records and various laboratory data should be accurately transcribed. To protect the privacy of the subjects, the names of the subjects should not appear on the CRF. (4) The trial data should be completely saved in accordance with GCP requirements for at least five years after the termination of the clinical trial or for a longer period as agreed. (5) The responsible professional department is responsible for the preservation and management of project materials (National Food and Drug Administration, ethics approval, investigator manual, trial protocol, informed consent form, research medical record, CRF, subject medication record or trial equipment usage record, etc.) for each clinical trial. The project materials of each clinical trial should be independently filed and saved in a separate volume. (6) The responsible person is responsible for the collection, distribution, return and preservation of clinical trial record documents (informed consent form, research medical record, CRF, subject medication diary card, etc.). The distributed and returned clinical trial record documents must be detailedly recorded in the department's document registration book. (7) The responsible person is responsible for collecting the clinical trial record documents after the observation of all subjects' trials is completed, handing them over to the principal investigator for review, and promptly handing them over to the institution office for re-examination and then storing them in the institution's archive room. (8) After the clinical trial is completed, the project materials and related documents of this project are responsible for being handed over to the institution's archive administrator, signed for acceptance, and then stored by the institution's archive room. (9) Without the permission of the department head, the principal investigator and the institution office, clinical trial documents shall not be borrowed. (10) Accept the monitoring and inspection by the monitor or inspector dispatched by the sponsor/CRO, the inspection and supervision by the drug supervision and administration department, and the inspection and supervision by the quality management personnel and the project quality control personnel of this profession, to ensure the quality of the clinical trial.
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：	2025-12-23 11:16:15