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

    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
    申请人名称
    联系人邮箱
    联系人邮编

    联系人通讯地址
    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
    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
    试验机构

    香港中文大學

    研究负责人电话
    研究负责人邮箱
    研究负责人邮编

    /

    联系人通讯地址

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