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【ChiCTR2400084947】Computer Use for Seniors on Mood Improvement and Logic Enhancement (CU-SMILE)

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基本信息

登记号

ChiCTR2400084947

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2024-05-28

临床申请受理号

靶点

适应症

Depression

试验通俗题目

Computer Use for Seniors on Mood Improvement and Logic Enhancement (CU-SMILE)

试验专业题目

Computer Use for Seniors on Mood Improvement and Logic Enhancement (CU-SMILE)

申办单位信息

申请人联系人

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申请人名称

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联系人邮编

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临床试验信息

试验目的

To improve mood symptoms in community-living older adults with depression using computerized cognitive training

试验分类

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试验类型

单臂

试验分期

其它

随机化

No randomization is needed, as this study only has one arm

盲法

试验项目经费来源

Knowledge Transfer Project Fund (KPF) of the Chinese University of Hong Kong, and Social Innovation and Entrepreneurship Development Fund (SIE Fund) of the Government of HKSAR

试验范围

目标入组人数

160

实际入组人数

第一例入组时间

2024-06-01

试验终止时间

2026-03-31

是否属于一致性

入选标准

Inclusion criteria are community-living Chinese individuals aged 60 years and older, and having a primary diagnosis of major depressive disorder (single or recurrent episodes without psychotic features) based on the DSM-5 criteria, with cognitive symptoms [Item 8 (slowness of thought and speech, impaired ability to concentrate) score ≥2 in HAM-D], but without dementia (based on the age- and education-specific cutoff of HK-MoCA).；

排除标准

Individuals who have suicidal idea, psychotic symptom, or are treatment-resistant [history of electroconvulsive therapy, transcranial magnetic stimulation, or no clinical response to ≥2 different classes of antidepressants] will be excluded and referred to the psychiatric services of the Hospital Authority. Other exclusion criteria are non-Chinese; living in care homes; having history or ongoing substance abuse (including alcohol), mania, bipolar or psychotic disorder, posttraumatic stress disorder, anxiety disorder, personality disorder, or mental disorder due to organic cause; having history of traumatic brain injury, Parkinson’s disease, stroke, dementia, or scoring below HK-MoCA cutoff; or having language barrier or impairment in communication (poor vision or hearing despite correction).；

研究者信息

研究负责人姓名

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试验机构

香港中文大學

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