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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selective Serotonin Reuptake Inhibitor（SSRIs）combined with Electronic cognitive training | Experimental | SSRIs（Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram）combined with Electronic cognitive training (60min, once a day) |
|
| SSRIs antidepressants combined with blank control Electronic training for 52 weeks | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qinge Zhang, PhD | Beijing Anding Hospital Affiliated to Capital Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anding Hospital Affiliated to Capital Medical University | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10513852 | Background | Mulsant BH, Ganguli M. Epidemiology and diagnosis of depression in late life. J Clin Psychiatry. 1999;60 Suppl 20:9-15. | |
| 30658276 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2022 | Oct 18, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 30, 2022 | Oct 18, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| D016666 | Fluvoxamine |
| D020280 | Sertraline |
| D015283 | Citalopram |
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010091 | Oximes |
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|
|
| 52week |
| 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 |
| 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 |
| 30611911 | Background | 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. |
| 30142588 | Background | 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. |
| 22940498 | Result | 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. |
| 39587504 | Derived | Wang X, Zhou J, Zhu K, Wang Y, Ma X, Ren L, Guo C, Zhang Z, Lu P, Zhang Q. Efficacy and safety of Neurocognitive Adaptive Training for Depression combined with SSRIs for treating cognitive impairment among patients with late-life depression: a 12-week, randomized controlled study. BMC Psychiatry. 2024 Nov 25;24(1):848. doi: 10.1186/s12888-024-06276-z. |
| D006898 |
| Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D015057 | 1-Naphthylamine |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011437 | Propylamines |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |