Electronic Training of Elderly Depression With Cognitive Impairment

NCT05588102 | Completed DMC

• 1 other identifier: Z191100006619061
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Geriatric Depression; Cognitive Impairment

Outcome Measures

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

  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 Outcomes (3)

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

  52week

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

  52week

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

  52week

Study Arms (2)

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)

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

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)

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

Interventions

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)

Also known as: Electronic cognitive training

SSRIs antidepressants combined with blank control Electronic training for 52 weeks; Selective Serotonin Reuptake Inhibitor（SSRIs）combined with Electronic cognitive training

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Anding Hospital Affiliated to Capital Medical University

Beijing, China

Location

Related Publications (6)

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

  PMID: 10513852 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.

  PMID: 30658276 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.

  PMID: 30611911 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.

  PMID: 30142588 BACKGROUND

• 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.

  PMID: 22940498 RESULT

• 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.

  PMID: 39587504 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Paroxetine; Fluvoxamine; Sertraline; Citalopram; Escitalopram

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oximes; Hydroxylamines; Amines; Organic Chemicals; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Qinge Zhang, PhD

  Beijing Anding Hospital Affiliated to Capital Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: October 20, 2022
• Study Start: May 18, 2021
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

CN (1)