ChiCTR2600120947 版本V1.0 版本创建时间2026/03/23 16:49:04 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：

ChiCTR2600120947 

最近更新日期：

Date of Last Refreshed on：

2026-03-23 16:48:26 

注册时间：

Date of Registration：

2026-03-23 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

美金刚联合艾司西酞普兰快速抗抑郁作用的多模态机制研究

Public title：

Multimodal Mechanistic Study of the Rapid Antidepressant Effect of Memantine Combined with Escitalopram

注册题目简写：

English Acronym：

研究课题的正式科学名称：

美金刚联合艾司西酞普兰快速抗抑郁作用的多模态机制研究

Scientific title：

Multimodal Mechanistic Study of the Rapid Antidepressant Effect of Memantine Combined with Escitalopram

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：

李慧 

研究负责人：

王刚 

Applicant：

Li Hui 

Study leader：

Wang Gang 

申请注册联系人电话：

Applicant telephone：

+86 158 5455 5643

研究负责人电话：

Study leader's telephone：

+86 10 5930 3005

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：

sy1342409570@163.com

研究负责人电子邮件：

Study leader's E-mail：

gangwangdoc@gmail.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：

北京市西城区安康胡同 5 号

研究负责人通讯地址：

北京市西城区安康胡同 5 号

Applicant address：

No. 5 Ankang Hutong, Xicheng District, Beijing

Study leader's address：

No. 5 Ankang Hutong, Xicheng District, Beijing

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：

首都医科大学附属北京安定医院

Applicant's institution：

Beijing Anding Hospital, Capital Medical University

研究负责人所在单位：

首都医科大学附属北京安定医院

Affiliation of the Leader：

Beijing Anding Hospital, Capital Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

(2025)科研第(595)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：

首都医科大学附属北京安定医院伦理委员会

Name of the ethic committee：

Ethics Committee of Beijing Anding Hospital, Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-12-17 00:00:00

伦理委员会联系人：

姜萌

Contact Name of the ethic committee：

Jiang Meng

伦理委员会联系地址：

北京市西城区安康胡同 5 号

Contact Address of the ethic committee：

No. 5 Ankang Hutong, Xicheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 5834 0320

伦理委员会联系人邮箱：

Contact email of the ethic committee：

anding_lunli@sina.com

研究实施负责（组长）单位：

首都医科大学附属北京安定医院

Primary sponsor：

Beijing Anding Hospital, Capital Medical University

研究实施负责（组长）单位地址：

北京市西城区安康胡同 5 号

Primary sponsor's address：

No. 5 Ankang Hutong, Xicheng District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京安定医院

具体地址：

北京市西城区安康胡同 5 号

Institution
hospital：

Beijing Anding Hospital

Address：

No. 5 Ankang Hutong, Xicheng District, Beijing

经费或物资来源：

首都医科大学附属北京安定医院自筹经费

Source(s) of funding：

Self-raised funds from Beijing Anding Hospital, Capital Medical University

Target disease：

Major depressive disorder

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：

主要目的： 比较美金刚缓释胶囊联合草酸艾司西酞普兰片（试验组）与草酸艾司西酞普兰片单药（对照组）治疗抑郁症患者的疗效差异。 次要目的： ①基于脑磁图（MEG）和磁共振（MRI）技术，分析两组患者治疗前后内侧前额叶皮层（mPFC）区域神经活动指标的动态变化，探索联合治疗快速抗抑郁的神经机制，并评估上述指标与临床结局指标的相关性； ②借助组学分析，筛选联合治疗相关的差异标志物及调控通路，阐明其快速抗抑郁的分子机制，同时探究差异标志物表达水平与临床结局指标的关联性。  

Objectives of Study：

Primary Objective To compare the efficacy difference between memantine sustained-release capsules combined with escitalopram oxalate tablets (experimental group) and escitalopram oxalate tablets alone (control group) in the treatment of patients with major depressive disorder. Secondary Objectives 1. Based on magnetoencephalography (MEG) and magnetic resonance imaging (MRI) techniques, to analyze the dynamic changes of neural activity indicators in the medial prefrontal cortex (mPFC) of patients in the two groups before and after treatment, explore the neural mechanism of rapid antidepressant effect of combined treatment, and evaluate the correlation between the above indicators and clinical outcome indicators; 2. With the help of omics analysis, to screen the differential markers and regulatory pathways related to combined treatment, clarify the molecular mechanism of its rapid antidepressant effect, and explore the correlation between the expression level of differential markers and clinical outcome indicators.

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）年龄18-64岁；2）符合DSM-5抑郁症诊断标准，目前为中度或重度抑郁发作，且当前抑郁发作至少持续4周，并经《简明国际神经精神访谈》（Mini-International Neuropsychiatric Interview, M.I.N.I. 7.0.2）确认；3）筛选基线时，蒙哥马利-艾森贝格抑郁量表（MADRS）评分≥ 26分，且临床总体印象-严重程度（CGI-S）评分≥4分；4）女性受试者必须具有阴性血清 β 人绒毛膜促性腺激素 （HCG） 妊娠试验和阴性尿妊娠试验，并同意遵守方案中任何适用的避孕要求；5）自愿参加并签署知情同意书。

Inclusion criteria

1. Aged 18 to 64 years; 2. Meet the diagnostic criteria for major depressive disorder (MDD) in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), currently in a moderate or severe depressive episode, with the current depressive episode lasting for at least 4 weeks, confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I. 7.0.2); 3. At screening baseline, the Montgomery-?sberg Depression Rating Scale (MADRS) score is >= 26, and the Clinical Global Impression-Severity (CGI-S) score is >= 4; 4. Female subjects must have a negative serum β-human chorionic gonadotropin (HCG) pregnancy test and a negative urine pregnancy test, and agree to comply with any applicable contraceptive requirements in the protocol; 5. Voluntarily participate in the study and sign the informed consent form.

排除标准：

1）存在其他精神障碍疾病病史及诊断；2）有自杀高风险，即筛选至基线时MADRS第10项评分≥4分；3）难治性抑郁、器质性精神障碍、继发性抑郁；4）患有严重或不稳定的躯体疾病（如肝肾功能严重不全、癫痫、甲状腺疾病、Q-T间期延长、糖尿病、有出血风险疾病等）；5）存在药物滥用史；药物或酒精依赖；氯胺酮或其对映体暴露史；6）筛选前2周内接受过以下相关治疗：抗抑郁药物治疗（氟西汀：筛选前4周禁用）；单胺氧化酶抑制剂（MAOI）；抗精神病药物或精神活性药物（心境稳定剂药物、致幻剂等）；7）3个月内接受过电休克治疗或其他物理治疗；8）对任何试验用药品中任何成份有过敏、超敏反应，或不耐受的受试者；9）哺乳期妇女，或近期计划妊娠妇女；10）无法配合服药或完成相关数据采集。

Exclusion criteria：

1. A history and diagnosis of other mental disorders; 2. High risk of suicide, i.e., a score of >= 4 on Item 10 of the MADRS from screening to baseline; 3. Treatment-resistant depression, organic mental disorders, and secondary depression; 4. Suffering from severe or unstable physical diseases (such as severe liver and kidney insufficiency, epilepsy, thyroid diseases, prolonged Q-T interval, diabetes mellitus, diseases with bleeding risk, etc.); 5. A history of drug abuse; drug or alcohol dependence; a history of exposure to ketamine or its enantiomers; 6. Having received the following relevant treatments within 2 weeks before screening: antidepressant treatment (fluoxetine: prohibited within 4 weeks before screening); monoamine oxidase inhibitors (MAOIs); antipsychotic drugs or psychoactive drugs (mood stabilizers, hallucinogens, etc.); 7. Having received electroconvulsive therapy or other physical therapies within 3 months; 8. Subjects who are allergic, hypersensitive, or intolerant to any component of any study drug; 9. Lactating women or women planning to become pregnant in the near future; 10. Unable to cooperate with medication administration or complete relevant data collection.

研究实施时间：

Study execute time：

从 From 2025-12-01 00:00:00至 To 2027-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-03-23 00:00:00 至 To 2027-07-31 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

30

Group：

Control Group

Sample size：

干预措施：

在为期一周的导入期内，对照组予美金刚缓释胶囊模拟剂（外观和味道与美金刚缓释胶囊相同，且内容物为淀粉、不具美金刚药效的物质）治疗，并在导入期结束后重新进行MADRS评估，将两组患者中MADRS 分值较导入期前（day-7）降低 ≥20% 安慰剂效应明显受试者剔除。治疗期第一周，对照组予美金刚缓释胶囊模拟剂联合草酸艾司西酞普兰片10mg/d治疗。治疗期第二周至第六周治疗结束，对照组保持美金刚缓释胶囊模拟剂联合草酸艾司西酞普兰片20mg/d治疗。

干预措施代码：

Intervention：

During the one-week run-in period, the control group was treated with memantine sustained-release capsule placebo (with the same appearance and taste as memantine sustained-release capsules, and the content was starch, a substance without memantine efficacy). After the end of the run-in period, the MADRS assessment was re-conducted, and subjects in both groups with a ≥20% reduction in MADRS score compared with that before the run-in period (day -7) and obvious placebo effect were excluded. In the first week of the treatment period, the control group was treated with memantine sustained-release capsule placebo combined with escitalopram oxalate tablets at a dose of 10 mg/day. From the second week to the end of the sixth week of the treatment period, the control group maintained the treatment with memantine sustained-release capsule placebo combined with escitalopram oxalate tablets at a dose of 20 mg/day.

Intervention code：

组别：

试验组

样本量：

30

Group：

Study Group

Sample size：

干预措施：

在为期一周的导入期，试验组予美金刚缓释胶囊14mg/d治疗，并在导入期结束后重新进行MADRS评估，将两组患者中MADRS 分值较导入期前（day-7）降低 ≥20% 安慰剂效应明显受试者剔除。治疗期第一周，予美金刚缓释胶囊21mg/d联合草酸艾司西酞普兰片10mg/d治疗；治疗期第二周至第六周治疗结束，试验组保持美金刚缓释胶囊28mg/d联合草酸艾司西酞普兰片20mg/d治疗。

干预措施代码：

Intervention：

During the one-week run-in period, the study group was treated with memantine sustained-release capsules at 14 mg/day. After the end of the run-in period, the MADRS assessment was re-conducted, and subjects in both groups with a ≥20% reduction in MADRS score compared with that before the run-in period (day -7) and obvious placebo effect were excluded. In the first week of the treatment period, the study group was treated with memantine sustained-release capsules at 21 mg/day combined with escitalopram oxalate tablets at 10 mg/day. From the second week to the end of the sixth week of the treatment period, the study group maintained the treatment with memantine sustained-release capsules at 28 mg/day combined with escitalopram oxalate tablets at 20 mg/day.

Intervention code：

组别：

试验组（预实验）

样本量：

10

Group：

Test group (pre test)

Sample size：

干预措施：

美金刚缓释胶囊治疗

干预措施代码：

Intervention：

The study group was treated with memantine sustained-release capsules

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

首都医科大学附属北京安定医院 

单位级别：

三甲 

Institution
hospital：

Beijing Anding Hospital, Capital Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

缓解率（MADRS 分值≤12分的受试者百分比）

指标类型：

次要指标

Outcome：

Response Rate (Percentage of subjects with Montgomery-Asberg Depression Rating Scale score <= 12)

Type：

Secondary indicator

测量时间点：

基线期，治疗期第1天、3天、1周、2周、4周、6周

测量方法：

MADRS量表评估

Measure time point of outcome：

Baseline period, treatment period day 1, day 3, 1 week, 2 weeks, 4 weeks, 6 weeks

Measure method：

Montgomery-Asberg Depression Rating scale assessment

指标中文名：

YMRS评分、PHQ-9评分、GAD-7评分、ISI 评分、CGI-S 评分、CGI-I 评分、VAS评分较基线变化值

指标类型：

次要指标

Outcome：

Change from baseline in Young Mania Rating Scale score, Patient Health Questionnaire-9 score, Generalized Anxiety Disorder Assessment-7 score, Insomnia Severity Index, Clinical Global Impression-Severity scale score,Clinical Global Impression-Improvement scale score, and Visual Analogue Scale score

Type：

Secondary indicator

测量时间点：

导入期，基线期，治疗期第1天、3天、1周、2周、4周、6周

测量方法：

YMRS、PHQ-9、GAD-7、ISI 、CGI-S 、CGI-I 、VAS量表评估

Measure time point of outcome：

Introduction period, baseline period, treatment period day 1, day 3, 1 week, 2 weeks, 4 weeks, 6 weeks

Measure method：

Assessment using YMRS, PHQ-9, GAD-7, ISI, CGI-S, CGI-I, and VAS scales

指标中文名：

TESS评分和AE的种类、频率

指标类型：

次要指标

Outcome：

Treatment Emergent Symptom Scale Scores and Types and Frequencies of Adverse Event

Type：

Secondary indicator

测量时间点：

基线期，治疗期第1天、3天、1周、2周、4周、6周

测量方法：

TESS量表评估及AE种类、数量记录

Measure time point of outcome：

Baseline, treatment day 1, day 3, week 1, week 2, week 4, week 6

Measure method：

Treatment Emergent Symptom Scale scale assessment and recording of AE types and numbers

指标中文名：

MADRS评分较基线期变化值

指标类型：

次要指标

Outcome：

Change in Montgomery-Asberg Depression Rating Scale score from baseline

Type：

Secondary indicator

测量时间点：

筛选期，导入期，基线期，治疗期第1天、3天、2周、4周、6周

测量方法：

MADRS量表评估

Measure time point of outcome：

Screening period, import period, baseline period, treatment period Day 1, Day 3, 2 weeks, 4 weeks, 6 weeks

Measure method：

Montgomery-Asberg Depression Rating scale assessment

指标中文名：

脑磁图数据

指标类型：

次要指标

Outcome：

Magnetoencephalography data

Type：

Secondary indicator

测量时间点：

用药前、基线期、1周末、6周末

测量方法：

脑磁图和头颅磁共振检查

Measure time point of outcome：

Before medication, baseline period, end of week 1, end of week 6

Measure method：

Magnetoencephalography and cranial magnetic resonance examination

指标中文名：

有效率（MADRS 分值降低≥50%的受试者百分比）

指标类型：

次要指标

Outcome：

Efficacy (Percentage of subjects with a >=50% reduction in Montgomery-Asberg Depression Rating Scale score)

Type：

Secondary indicator

测量时间点：

基线期，治疗期第1天、3天、1周、2周、4周、6周

测量方法：

MADRS量表评估

Measure time point of outcome：

Baseline period, treatment period day 1, day 3, 1 week, 2 weeks, 4 weeks, 6 weeks

Measure method：

Montgomery-Asberg Depression Rating scale assessment

指标中文名：

血液组学标志物

指标类型：

次要指标

Outcome：

Bloodomics Biomarkers

Type：

Secondary indicator

测量时间点：

用药前、基线期、1周末、6周末

测量方法：

组学测量

Measure time point of outcome：

Pre medication, baseline, 1 weekend, 6 weekends

Measure method：

Omics measurement

指标中文名：

MADRS评分较基线期变化值

指标类型：

主要指标

Outcome：

Change in Montgomery-Asberg Depression Rating Scale score from baseline

Type：

Primary indicator

测量时间点：

治疗期第1周末

测量方法：

MADRS量表评估

Measure time point of outcome：

The first weekend of treatment period

Measure method：

Montgomery-Asberg Depression Rating scale assessment

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

 使用后保存  

说明

Fate of sample：

Preservation 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 18 岁 years
最大 Max age 64 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）：

使用基于windows系统的SAS9.4软件中PLAN步产生随机数列。

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

The plan step in sas9.4 software based on Windows system is used to generate random sequence.

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：

入组的被试和项目研究人员双盲

Blinding：

Both the enrolled subjects and the project researchers were double-blinded.

是否共享原始数据：

IPD sharing

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.数据录入（选择纸质/电子记录表格，是否双录入，是否电子化数据采集系统等） 每位被试的数据采集完成后，所需要录入的数据包括一般资料数据、临床资料数据、临床症状评估、MRI数据、MEG数据和组学数据六部分。一般资料数据、临床资料数据和临床症状评估均在纸质版数据采集完成后使用SPSS软件进行电子版录入。MRI和MEG数据采集完成后需将原始数据按照规定的格式上传至脑测量平台进行管理，同时需用SPSS软件详细记录试验期间的情况，包括：成功采集的时间序列、各序列的采集顺序、采集过程中被试的头动情况、未完成采集序列的具体原因。组学数据：血液样本采集后，其基础信息先记录于纸质实验记录表，随后录入实验室专用电子台账；原始质谱数据按“subject--timepoint”格式（如“sub-001--day0”）上传至组学数据管理系统，同时在SPSS中同步录入关键信息，包括样本编号与被试 ID 的对应关系、各时间点样本的预处理状态、检测批次及质量控制结果、数据是否符合分析标准及异常情况原因。 数据录入采用 “纸质记录→电子录入” 的流程。所有数据（包括一般资料、临床资料、临床量表评分、MRI数据、MEG数据及组学数据）均由研究人员完成电子录入。为确保数据质量，录入完成后研究人员将对关键数据进行全面复核，并与原始记录进行一致性校验。所有电子记录均与原始文件建立唯一关联编号，确保数据全程可溯源。 2. 数据核查和管理的内容和方式 数据核查工作将由研究人员分阶段实施质量控制。研究人员在数据采集过程中需实时检查数据的完整性与质量，对不符合要求的数据立即安排补充采集或重新采集。在每日工作结束后，研究人员需对当日采集的所有数据执行复核，核查数据数量、完整性与规范性，如发现不合格数据应及时采取补救措施（如重新安排脑电图检测等）。所有电子数据均与原始记录建立唯一关联编号，确保全程可追溯。 3.数据存档 病例报告表在按要求完成数据录入和核查后，按编号的顺序归档保存，并填有检索目录等，以备查考。电子数据文件包括MRI数据、MEG数据、组学数据、数据库、检查程序、分析程序、分析结果、编码本和说明文件等，应分类保存，并有多个备份保存于不同磁盘或记录介质上，妥善保存，防止损坏。所有原始档案应按相应规定内的期限保存，一般保存时间为5年。

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

1. Data Entry (Paper/electronic record forms, double entry, electronic data capture system, etc.) After completion of data collection for each subject, the data to be entered include six parts: demographic data, clinical data, clinical symptom assessments, MRI data, MEG data, and omics data.Demographic data, clinical data, and clinical symptom assessments are entered electronically into SPSS software after completion of paper-based data collection.Upon completion of MRI and MEG data acquisition, the raw data must be uploaded to a neuroimaging platform in a standardized format for management. Meanwhile, SPSS software is used to record detailed information during the scanning sessions, including: successful acquisition time series, acquisition order of each sequence, head motion of the subject during acquisition, and specific reasons for uncompleted sequences.For omics data: after blood sample collection, basic information is first recorded on a paper-based experimental record form, and then entered into a dedicated electronic laboratory log; raw mass spectrometry data are uploaded to the omics data management system in the "subject--timepoint" format (e.g., "sub-001--day0"). Key information is simultaneously entered into SPSS, including the correspondence between sample numbers and subject IDs, preprocessing status of samples at each time point, testing batches and quality control results, whether data meet analytical standards, and reasons for abnormalities. Data entry follows the workflow of paper-based recording → electronic entry.All data (including demographic data, clinical data, clinical scale scores, MRI data, MEG data, and omics data) are entered electronically by researchers. To ensure data quality, researchers conduct a comprehensive review of key data after entry and verify consistency with the original records. All electronic records are assigned a unique identifier linked to the original documents to ensure full data traceability. 2. Content and Methods of Data Verification and Management Data verification is performed by researchers in phases for quality control.During data collection, researchers inspect the completeness and quality of data in real time. Data that do not meet requirements are immediately supplemented or recollected.At the end of each working day, researchers review all data collected that day to verify quantity, completeness, and standardization. Remedial measures (such as rescheduling electroencephalography examinations) are taken promptly if invalid data are identified.All electronic data are assigned a unique identifier linked to the original records to ensure full traceability. 3. Data Archiving After data entry and verification are completed as required, case report forms are filed in numerical order with a retrieval index for future reference.Electronic data files, including MRI data, MEG data, omics data, databases, inspection programs, analysis programs, analysis results, codebooks, and documentation, are classified and stored with multiple backups on different disks or storage media to prevent damage.All original archives are retained for the period specified in relevant regulations, generally 5 years.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

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  2026-03-23 16:48:26