Skip to main content
OpenTrials
Completed

NCT Number: NCT05588102

Electronic Training of Elderly Depression With Cognitive Impairment

late-life depression (LLD) is the most common mental illness in the elderly. Due to the increasing prevalence of population aging, it has become one of the important factors affecting the quality of life of the elderly. 50-70% of elderly patients with depression are accompanied by different degrees of cognitive impairment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Geriatric Depression Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Neurocognitive Disorders

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anding Hospital Affiliated to Capital Medical University

Beijing, China

About this study

Elderly patients with depression with cognitive impairment have a greater risk of dementia conversion, a worse prognosis and a higher recurrence rate. Therefore, it is urgent to provide evidence-based early intervention strategies for geriatric depression with cognitive impairment. At present, domestic and foreign guidelines do not provide clear and effective treatment plans for elderly patients with depression with cognitive impairment, and clinical research and practice also lack evidence-based treatment methods. Selective Serotonin Reuptake Inhibitors (SSRIs), the most commonly used antidepressants, do not significantly improve the cognitive impairment of elderly patients with depression, and may even aggravate the cognitive impairment of elderly patients with depression. The overall efficacy and tolerability of drug therapy in elderly patients with depression and cognitive impairment are poor. Studies have confirmed that Cognitive training can significantly improve the overall Cognitive function and multiple Cognitive domains of healthy elderly people, patients with Mild Cognitive Impairment (MCI) and Alzheimer's disease (AD). Previous studies have also preliminarily confirmed the cognitive improvement effect of cognitive training on elderly patients with depression, which provides a new idea for clinical diagnosis and treatment. Therefore, based on the urgent clinical needs and preliminary work, the development and clinical validation of a set of standardized cognitive training methods suitable for elderly patients with depression and cognitive impairment will be conducive to improve the overall efficacy of elderly patients with depression, improve the prognosis of patients, and save health resources.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients and their family members signed the written informed consent
  • Age ≥60 years old
  • Meet the diagnostic criteria for single or recurrent major depressive disorder in the diagnostic and Statistical Manual of mental disorders Fourth Edition (DSM-V)
  • Currently in the acute phase, HAMD-17 total score at baseline ≥ 18 points
  • There are symptoms of cognitive impairment, Montreal Cognitive Assessment scale (Montreal Cognitive Assessment scale, MoCA) <26 points
  • Education level above primary school.

Exclusion criteria

  • Patients with history of epilepsy or coronary heart disease or other serious unstable physical diseases
  • Participated in another intervention clinical study in the past 1 month
  • The following mental diseases have been or are currently diagnosed by DSM-V: organic mental disorder, Alzheimer's disease, secondary dementia caused by other causes, schizophrenia, schizophrenic affective disorder, bipolar disorder, delusional disorder, undefined mental disease, patients with drug abuse history, including alcohol and active drug abuse in the past 12 months, except nicotine
  • He has been taking antidepressants, mental retardants and other psychiatric drugs for the past 2 weeks
  • Severe aphasia, visual and hearing impairment, etc. unable to complete the scale evaluation

Treatment and study plan

Selective Serotonin Reuptake Inhibitor（SSRIs，Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram）

Drug

Subjects in the intervention group received SSRIs antidepressants combined with Electronic cognitive training based on mobile phone platform for 52 weeks (once a day, 60min each time)

Other names: Electronic cognitive training

Primary outcomes

  1. At the end of the 12th week of treatment, the change value of ADAS-Cog score of subjects in the two groups compared with baseline

    Time frame: 12 week

    The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) was developed in the 1980s to assess the level of cognitive dysfunction in Alzheimer's disease.The score of the scale is about 0-75 points, and the higher the score, the cognitive function decreases significantly

Secondary outcomes

  1. At each follow-up point, the change value of ADAS cog scale score of subjects in the two groups compared with baseline;

    Time frame: 52week

    The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) was developed in the 1980s to assess the level of cognitive dysfunction in Alzheimer's disease.The score of the scale is about 0-75 points, and the higher the score, the cognitive function decreases significantly.

  2. At each follow-up point, the change value of HAMD-17 scale score of subjects in the two groups compared with baseline;

    Time frame: 52week

    17-Item Hamilton Rating Scale for Depression (HAMD-17)， Mild depression: HAMD-17 scores > 7 points, ≤ 17 points; Moderate depression: HAMD 17 scores > 17 points, ≤ 24 points;Severe depression: HAMD 17 scores > 24 points.

  3. At each follow-up point, the change value of HAMA scale score of subjects in the two groups compared with baseline;

    Time frame: 52week

    Hamilton Anxiety Scale (HAMA) is used to assess the anxiety level of patients. The 14 item cutoff value of HAMA is 14 points. The higher the score, the more serious the anxiety level.

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Research on Standardized Electronic Cognitive Training Technique in Early Stage of Senile Depression With Cognitive Impairment

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2022
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.