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注册号: Registration number: |
ChiCTR2600121465 |
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最近更新日期: Date of Last Refreshed on: |
2026-03-31 10:16:21 |
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注册时间: Date of Registration: |
2026-03-31 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
阈下抑郁老年人怀旧行为过程中大脑激活模式的性别差异:一项基于任务态的功能磁共振成像研究 |
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Public title: |
Gender Differences in Brain Activation Patterns During Nostalgia-Related Tasks in Older Adults With Subthreshold Depression: A Task-Based Functional Magnetic Resonance Imaging Study |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
阈下抑郁老年人怀旧行为过程中大脑激活模式的性别差异:一项基于任务态的功能磁共振成像研究 |
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Scientific title: |
Gender Differences in Brain Activation Patterns During Nostalgia-Related Tasks in Older Adults With Subthreshold Depression: A Task-Based Functional Magnetic Resonance Imaging Study |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
杨欣 |
研究负责人: |
吴冬梅 |
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Applicant: |
Xin Yang |
Study leader: |
Dongmei Wu |
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申请注册联系人电话: Applicant telephone: |
+86 135 4829 0843 |
研究负责人电话:
Study leader's |
+86 181 9072 1952 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
13548290843@163.com |
研究负责人电子邮件: Study leader's E-mail: |
wudongmei_2001@163.com |
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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): |
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申请注册联系人通讯地址: |
四川省成都市青羊区一环路西二段32号 |
研究负责人通讯地址: |
四川省成都市青羊区一环路西二段32号 |
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Applicant address: |
No. 32, West Second Section of First Ring Road, Qingyang District, Chengdu City, Sichuan Province |
Study leader's address: |
No. 32, West Second Section of First Ring Road, Qingyang District, Chengdu City, Sichuan Province |
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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: |
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申请人所在单位: |
四川省医学科学院·四川省人民医院 |
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Applicant's institution: |
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital |
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研究负责人所在单位: |
四川省医学科学院·四川省人民医院 |
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Affiliation of the Leader: |
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
伦审(研)2025年第976号 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
四川省医学科学院·四川省人民医院基础及临床研究伦理委员会 |
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Name of the ethic committee: |
Ethics Committee for Basic and Clinical Research of Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2026-01-06 00:00:00 | ||
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伦理委员会联系人: |
谢可 |
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Contact Name of the ethic committee: |
Ke Xie |
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伦理委员会联系地址: |
四川省成都市青羊区一环路西二段32号 |
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Contact Address of the ethic committee: |
No. 32, West Second Section of First Ring Road, Qingyang District, Chengdu City, Sichuan Province |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 28 8739 3449 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
四川省医学科学院·四川省人民医院 |
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Primary sponsor: |
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital |
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研究实施负责(组长)单位地址: |
四川省成都市青羊区一环路西二段32号 |
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Primary sponsor's address: |
No. 32, West Second Section of First Ring Road, Qingyang District, Chengdu City, Sichuan Province |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自筹 |
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Source(s) of funding: |
Self-funded |
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研究疾病: |
老年人阈下抑郁 |
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Target disease: |
Subthreshold depression in the elderly |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
横断面 |
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Study design: |
Cross-sectional |
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研究目的: |
揭示老年阈下抑郁群体在怀旧过程中的普遍性大脑激活网络,探究老年阈下抑郁群体在怀旧过程中大脑激活模式的性别差异并进一步探索神经活动中的性别差异是否与个体的主观情绪体验、临床症状或心理特质存在关联; |
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Objectives of Study: |
To reveal the universal brain activation networks during the nostalgia process in elderly individuals with subthreshold depression (StD); to explore the gender differences in brain activation patterns during nostalgia within this population; and to further investigate whether these gender-related neurobiological differences are associated with individuals' subjective emotional experiences, clinical symptoms, or psychological traits. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
1.T1 显示脑梗塞(腔隙性梗死 >15 mm)或其他血管性损伤; 2.严重躯体疾病不能耐受; 3.与脑结构变化相关疾病:如脑肿瘤,肿瘤转移性疾病;不稳定的躯体疾病,如重性哮喘;癫痫及其他神经变性疾病;可能导致心境障碍症状的躯体疾病,如多发性硬化、甲状腺疾病等; 4.简易精神状态检查表(Mini-mental State Examination, MMSE)筛查有认知障碍者(MMSE 评分文盲组<=17 分,小学组<=20 分,中学及以上组<=24 分); 5.既往诊断精神障碍或现患精神障碍者; 6.2 个月内有抗精神病药史或酗酒史; 7.幽闭紧张或体内有金属植入物等,不能进行 MRI 检查者; 8.研究期间参与其他项目者; 9.既往诊断抑郁症、双相情感障碍者。 |
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Exclusion criteria: |
1. T1 shows cerebral infarction (lacunar infarction >15 mm) or other vascular damage; 2. Severe physical illness that cannot be tolerated; 3. Diseases related to brain structural changes: such as brain tumors, metastatic tumor diseases; unstable physical illnesses, such as severe asthma; epilepsy and other neurodegenerative diseases; physical diseases that may cause mood disorder symptoms, such as multiple sclerosis, thyroid diseases, etc.; 4. Cognitive impairment detected by the Mini-Mental State Examination (MMSE) screening (MMSE score: illiterate group <=17 points, primary school group <=20 points, middle school and above group <=24 points); 5. Previous diagnosis of mental disorder or current mental disorder; 6. History of antipsychotic medication or alcoholism within the past 2 months; 7. Claustrophobia or metal implants in the body, unable to undergo MRI examination; 8. Participation in other projects during the study period; 9. Previous diagnosis of depression or bipolar disorder. |
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研究实施时间: Study execute time: |
从 From 2026-03-29 00:00:00至 To 2027-03-06 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2026-04-01 00:00:00 至 To 2027-01-06 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
None |
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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 |
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盲法: |
无 |
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Blinding: |
None |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
否No |
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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 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
None |
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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: |
CRF |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
CRF |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
无/No |