One-Year Trajectory of Cognitive Changes in Patients With Late-life Depression in the Short Term

NCT06447428 | Recruiting

• 1 other identifier: K2021-03-029
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Late Life Depression

Outcome Measures

Primary Outcomes (2)

• Montreal cognitive assessment scale (MoCA)

  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.

  2023.6.1-2024.8.1

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

  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.

  2023.6.1-2024.8.1

Secondary Outcomes (8)

• 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

• Social Support Rating Scale (SSRS)

  2023.6.1-2024.8.1

• Lubben Social Network Scale (LSNS-6)

  2023.6.1-2024.8.1

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medial University

Fuzhou, Fujian, 350100, China

RECRUITING

Study Officials

• Ziping Zhu

  Fujian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Li

CONTACT

18120826271; leehong99@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: June 7, 2024
• Study Start: June 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2025.6-2026.6
• Access Criteria: To obtain the data, you need to send an email address to the researcher himself

Locations

CN (1)