AzTrials
AzTrials

Geriatric DepressionNCT05588102

Electronic Training of Elderly Depression With Cognitive Impairment

A study testing Selective Serotonin Reuptake Inhibitor（SSRIs，Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram） in people with Geriatric Depression and Cognitive Impairment, run by Capital Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Geriatric Depression, Cognitive Impairment
What is being tested?
Selective Serotonin Reuptake Inhibitor（SSRIs，Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram）
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
1 siteChina
Study dates
18 May 2021to 1 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Anding Hospital Affiliated to Capital Medical University

    Beijing

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Selective Serotonin Reuptake Inhibitor（SSRIs，Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram）
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Electronic cognitive training

    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)

Study groups in NCT05588102
Study groupRoleWhat they receive
Selective Serotonin Reuptake Inhibitor（SSRIs）combined with Electronic cognitive trainingExperimentalSSRIs（Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram）combined with Electronic cognitive training (60min, once a day)
Receives: Drug: Selective Serotonin Reuptake Inhibitor（SSRIs，Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram）
SSRIs antidepressants combined with blank control Electronic training for 52 weeksPlacebo comparatorSSRIs 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)
Receives: Drug: Selective Serotonin Reuptake Inhibitor（SSRIs，Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram）

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 week

Secondary outcomes (3)

  1. 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.

    Measured: 52week

  2. 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.

    Measured: 52week

  3. 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.

    Measured: 52week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2022
  2. Study start18 May 2021
  3. Primary completion1 May 2023
  4. Study completion1 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05588102
Sponsor's protocol ID
Z191100006619061
Status last verified
Jul 2024
First submitted
17 Aug 2022
Last updated
16 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

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

    PubMed 10513852

  • 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.

    PubMed 30658276

  • 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.

    PubMed 30611911

  • 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.

    PubMed 30142588

  • 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.

    PubMed 22940498

  • 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.

    PubMed 39587504

Questions about this trial

What is this clinical trial studying?

A study testing Selective Serotonin Reuptake Inhibitor（SSRIs，Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram） in people with Geriatric Depression and Cognitive Impairment, run by Capital Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 12 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05588102, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.

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