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Clinical Trials/NCT06447428
NCT06447428
Recruiting
N/A

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

Fujian Medical University1 site in 1 country400 target enrollmentJune 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Late Life Depression
Sponsor
Fujian Medical University
Enrollment
400
Locations
1
Primary Endpoint
Subjective cognitive decline questionnaire (SCD questionnaire 9, SCD-9)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
August 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Fujian Medical University
Responsible Party
Principal Investigator
Principal Investigator

Zhu Ziping

Principal Investigator

Fujian Medical University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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