Clinical trial NCT06447428: One-Year Trajectory of Cognitive Changes in Patients With Late-life Depression in the Short Term
Official title: One-Year Trajectory of Cognitive Changes in Patients With Late-life Depression in the Short Term: A Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Late Life Depression
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients with depression who met the inclusion and exclusion criteria were selected from a number of nursing facilities, hospitals and communities

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Montreal cognitive assessment scale (MoCA)
timeFrame: 2023.6.1-2024.8.1
measure: Subjective cognitive decline questionnaire (SCD questionnaire 9, SCD-9)
timeFrame: 2023.6.1-2024.8.1
Secondary outcomes:
measure: Activities of Daily Living (ADL)
timeFrame: 2023.6.1-2024.8.1
measure: general information
timeFrame: 2023.6.1-2024.8.1
measure: Self Rating Anxiety Scale (SAS)
timeFrame: 2023.6.1-2024.8.1
measure: Social Support Rating Scale (SSRS)
timeFrame: 2023.6.1-2024.8.1
measure: Lubben Social Network Scale (LSNS-6)
timeFrame: 2023.6.1-2024.8.1
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2023.6.1-2024.8.1
measure: Corner Davidson Resilience Scale (CDRISC)
timeFrame: 2023.6.1-2024.8.1
measure: Geriatric Depression Scale (GDS-15)
timeFrame: 2023.6.1-2024.8.1
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medial University
state: Fujian
Study officials:
affiliation: Fujian Medical University
name: Ziping Zhu
role: PRINCIPAL_INVESTIGATOR
References: