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临床试验/NCT06447428
NCT06447428招募中不适用

One-Year Trajectory of Cognitive Changes in Patients With Late-life Depression in the Short Term: A Longitudinal Cohort Study

Fujian Medical University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Subjective cognitive decline questionnaire (SCD questionnaire 9, SCD-9)

研究概览

简要总结

The purpose of this study was to investigate the one-year trajectory of cognitive change in elderly patients with depression, to explore the transfer characteristics and transfer rules of various states of cognitive impairment in patients, to predict the relevant risk factors of cognitive decline, and to find possible influencing factors affecting state change, so as to provide a theoretical basis and reference for subsequent targeted intervention research on geriatric depression.

详细描述

The 1-year prospective longitudinal study involved 400(prospective)subjects who met criteria for geriatric depression,the whole cognitive function was assessed by mini-mental state examination(MMSE),Montreal cognitive assessment scale-MOCA)and subjective cognitive decline scale(SCD-9).Cognitive function was monitored at 6 and 12 months.GAIN factors related to cognitive function(e.g.,age,gender,education,cognitive function,anxiety level,sleep,social support,resilience,social networks,etc.).By studying the longitudinal changes of cognitive function in the elderly patients with depression,a time-discrete and state-discrete multistate Markov model was constructed,namely,state 1(normal cognitive, NC),state 2(subjective cognitive decline, SCD),State 3(mild cognitive decline,MCI) and State 4(Alzheimer's disease,AD).In-depth analysis of some factors and indicators on the impact of the transfer between the states, the transfer between the states estimated probability.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • meeting the criteria for major depression in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
  • age at first onset ≥60 years
  • Informed consent

排除标准

  • Relevant past history affecting cognitive function: various types of stroke, traumatic brain injury, severe brain atrophy, mental abnormalities
  • Perennial alcohol addiction, or long-term use of various drugs that affect mental state
  • Survival time of malignant tumors and tumors
  • Patients with language, vision, and hearing impairments

结局指标

主要结局

Subjective cognitive decline questionnaire (SCD questionnaire 9, SCD-9)

时间窗: 2023.6.1-2024.8.1

The SCD-9 is mainly used to distinguish between normal people and SCD patients. The scale mainly consists of 2 dimensions, i.e., overall memory ability and time comparison (4 entries) and daily activity ability (5 entries), with a total of 9 entries, and the total scale score ranges from 0 to 9, with higher scores indicating a more severe degree of SCD.

Montreal cognitive assessment scale (MoCA)

时间窗: 2023.6.1-2024.8.1

The Changsha version of the MoCA questionnaire was used in this study, which included eight cognitive assessments of visuospatial and executive functions, naming, memory, attention, speech, abstraction, delayed recall, and orientation, with a total score of 30, with higher scores indicating better cognitive functioning.

次要结局

  • Social Support Rating Scale (SSRS)(2023.6.1-2024.8.1)
  • Lubben Social Network Scale (LSNS-6)(2023.6.1-2024.8.1)
  • Activities of Daily Living (ADL)(2023.6.1-2024.8.1)
  • general information(2023.6.1-2024.8.1)
  • Self Rating Anxiety Scale (SAS)(2023.6.1-2024.8.1)
  • Pittsburgh Sleep Quality Index (PSQI)(2023.6.1-2024.8.1)
  • Corner Davidson Resilience Scale (CDRISC)(2023.6.1-2024.8.1)
  • Geriatric Depression Scale (GDS-15)(2023.6.1-2024.8.1)

研究者

发起方
Fujian Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhu Ziping

Principal Investigator

Fujian Medical University

研究点 (1)

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