Electronic Training of Elderly Depression With Cognitive Impairment
NCT ID: NCT05588102
Last Updated: 2024-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2021-05-18
2023-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Selective Serotonin Reuptake Inhibitor（SSRIs）combined with Electronic cognitive training
SSRIs（Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram）combined with Electronic cognitive training (60min, once a day)
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)
SSRIs antidepressants combined with blank control Electronic training for 52 weeks
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)
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
60 Years
80 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Qinge Zhang
prof
Principal Investigators
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Qinge Zhang, PhD
Role: STUDY_CHAIR
Beijing Anding Hospital Affiliated to Capital Medical University
Locations
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Beijing Anding Hospital Affiliated to Capital Medical University
Beijing, , China
Countries
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References
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Mulsant BH, Ganguli M. Epidemiology and diagnosis of depression in late life. J Clin Psychiatry. 1999;60 Suppl 20:9-15.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Z191100006619061
Identifier Type: -
Identifier Source: org_study_id
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