Electronic Training of Elderly Depression With Cognitive Impairment
Primary Purpose
Geriatric Depression, Cognitive Impairment
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Selective Serotonin Reuptake Inhibitor(SSRIs,Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram)
Sponsored by
About this trial
This is an interventional treatment trial for Geriatric Depression
Eligibility Criteria
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
Sites / Locations
- Beijing Anding Hospital Affiliated to Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Selective Serotonin Reuptake Inhibitor(SSRIs)combined with Electronic cognitive training
SSRIs antidepressants combined with blank control Electronic training for 52 weeks
Arm Description
SSRIs(Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram)combined with Electronic cognitive training (60min, once a day)
SSRIs drug treatment (Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram)combined with the blank control Electronic training(subjects were allowed to use electronic products to browse the web and watch the news for 1 hours every day)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05588102
First Posted
August 17, 2022
Last Updated
October 18, 2022
Sponsor
Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05588102
Brief Title
Electronic Training of Elderly Depression With Cognitive Impairment
Official Title
Research on Standardized Electronic Cognitive Training Technique in Early Stage of Senile Depression With Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2021 (Actual)
Primary Completion Date
August 18, 2023 (Anticipated)
Study Completion Date
August 18, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geriatric Depression, Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Selective Serotonin Reuptake Inhibitor(SSRIs)combined with Electronic cognitive training
Arm Type
Experimental
Arm Description
SSRIs(Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram)combined with Electronic cognitive training (60min, once a day)
Arm Title
SSRIs antidepressants combined with blank control Electronic training for 52 weeks
Arm Type
Placebo Comparator
Arm Description
SSRIs drug treatment (Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram)combined with the blank control Electronic training(subjects were allowed to use electronic products to browse the web and watch the news for 1 hours every day)
Intervention Type
Drug
Intervention Name(s)
Selective Serotonin Reuptake Inhibitor(SSRIs,Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram)
Other Intervention Name(s)
Electronic cognitive training
Intervention Description
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)
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
12 week
Secondary Outcome Measure Information:
Title
At each follow-up point, the change value of ADAS cog scale score of subjects in the two groups compared with baseline;
Description
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.
Time Frame
52week
Title
At each follow-up point, the change value of HAMD-17 scale score of subjects in the two groups compared with baseline;
Description
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.
Time Frame
52week
Title
At each follow-up point, the change value of HAMA scale score of subjects in the two groups compared with baseline;
Description
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.
Time Frame
52week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiao wang
Phone
+8658303103
Email
wangxiaofight2016@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qinge Zhang, PhD
Organizational Affiliation
Beijing Anding Hospital Affiliated to Capital Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Anding Hospital Affiliated to Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qinge zhang
Phone
+8658303103
Email
zqe81@126.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
10513852
Citation
Mulsant BH, Ganguli M. Epidemiology and diagnosis of depression in late life. J Clin Psychiatry. 1999;60 Suppl 20:9-15.
Results Reference
background
PubMed Identifier
30658276
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.
Results Reference
background
PubMed Identifier
30611911
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.
Results Reference
background
PubMed Identifier
30142588
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.
Results Reference
background
PubMed Identifier
22940498
Citation
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.
Results Reference
result
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Electronic Training of Elderly Depression With Cognitive Impairment
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