Electronic Training of Elderly Depression With Cognitive Impairment

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05588102
• Other study ID #: Z191100006619061
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2021
• Est. completion date: January 4, 2024

Study information

• Verified date: January 2024
• Source: Capital Medical University
• Contact: xiao wang
• Phone: +8658303103
• Email: wangxiaofight2016[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: January 4, 2024
• Est. primary completion date: January 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The patients and their family members signed the written informed consent

2. Age =60 years old

3. Meet the diagnostic criteria for single or recurrent major depressive disorder in the diagnostic and Statistical Manual of mental disorders Fourth Edition (DSM-V)

4. Currently in the acute phase, HAMD-17 total score at baseline = 18 points

5. There are symptoms of cognitive impairment, Montreal Cognitive Assessment scale (Montreal Cognitive Assessment scale, MoCA) <26 points

6. Education level above primary school.

Exclusion Criteria:

1. Patients with history of epilepsy or coronary heart disease or other serious unstable physical diseases

2. Participated in another intervention clinical study in the past 1 month

3. 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

4. He has been taking antidepressants, mental retardants and other psychiatric drugs for the past 2 weeks

5. Severe aphasia, visual and hearing impairment, etc. unable to complete the scale evaluation

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Depression
• Depressive Disorder
• Geriatric Depression

Intervention

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

Locations

Country	Name	City	State
China	Beijing Anding Hospital Affiliated to Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

Buchtemann D, Luppa M, Bramesfeld A, Riedel-Heller S. Incidence of late-life depression: a systematic review. J Affect Disord. 2012 Dec 15;142(1-3):172-9. doi: 10.1016/j.jad.2012.05.010. Epub 2012 Aug 30. — View Citation

Goncalves-Pereira M, Prina AM, Cardoso AM, da Silva JA, Prince M, Xavier M; 10/66 Workgroup in Portugal. The prevalence of late-life depression in a Portuguese community sample: A 10/66 Dementia Research Group study. J Affect Disord. 2019 Mar 1;246:674-681. doi: 10.1016/j.jad.2018.12.067. Epub 2018 Dec 21. — View Citation

Horackova K, Kopecek M, Machu V, Kagstrom A, Aarsland D, Motlova LB, Cermakova P. Prevalence of late-life depression and gap in mental health service use across European regions. Eur Psychiatry. 2019 Apr;57:19-25. doi: 10.1016/j.eurpsy.2018.12.002. Epub 2019 Jan 15. — View Citation

Mulsant BH, Ganguli M. Epidemiology and diagnosis of depression in late life. J Clin Psychiatry. 1999;60 Suppl 20:9-15. — View Citation

Wang F, Zhang QE, Zhang L, Ng CH, Ungvari GS, Yuan Z, Zhang J, Zhang L, Xiang YT. Prevalence of major depressive disorder in older adults in China: A systematic review and meta-analysis. J Affect Disord. 2018 Dec 1;241:297-304. doi: 10.1016/j.jad.2018.07.061. Epub 2018 Jul 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	12 week
Secondary	At each follow-up point, the change value of ADAS cog scale score of subjects in the two groups compared with baseline;	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.	52week
Secondary	At each follow-up point, the change value of HAMD-17 scale score of subjects in the two groups compared with baseline;	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.	52week
Secondary	At each follow-up point, the change value of HAMA scale score of subjects in the two groups compared with baseline;	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.	52week