Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT05588102
Status:
COMPLETED
Last Update Posted:
2024-07-16
First Post:
2022-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electronic Training of Elderly Depression With Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017374', 'term': 'Paroxetine'}, {'id': 'D016666', 'term': 'Fluvoxamine'}, {'id': 'D020280', 'term': 'Sertraline'}, {'id': 'D015283', 'term': 'Citalopram'}, {'id': 'D000089983', 'term': 'Escitalopram'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010091', 'term': 'Oximes'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-30', 'size': 257693, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-18T02:42', 'hasProtocol': True}, {'date': '2022-06-30', 'size': 153634, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-10-18T02:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2022-08-17', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': '12 week', '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"}], 'secondaryOutcomes': [{'measure': 'At each follow-up point, the change value of ADAS cog scale score of subjects in the two groups compared with baseline;', 'timeFrame': '52week', '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."}, {'measure': 'At each follow-up point, the change value of HAMD-17 scale score of subjects in the two groups compared with baseline;', 'timeFrame': '52week', '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.'}, {'measure': 'At each follow-up point, the change value of HAMA scale score of subjects in the two groups compared with baseline;', 'timeFrame': '52week', '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Geriatric Depression', 'Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '10513852', 'type': 'BACKGROUND', 'citation': 'Mulsant BH, Ganguli M. Epidemiology and diagnosis of depression in late life. J Clin Psychiatry. 1999;60 Suppl 20:9-15.'}, {'pmid': '30658276', 'type': 'BACKGROUND', '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.'}, {'pmid': '30611911', 'type': 'BACKGROUND', '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.'}, {'pmid': '30142588', 'type': 'BACKGROUND', '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.'}, {'pmid': '22940498', 'type': 'RESULT', '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.'}, {'pmid': '39587504', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The patients and their family members signed the written informed consent\n2. Age ≥60 years old\n3. Meet the diagnostic criteria for single or recurrent major depressive disorder in the diagnostic and Statistical Manual of mental disorders Fourth Edition (DSM-V)\n4. Currently in the acute phase, HAMD-17 total score at baseline ≥ 18 points\n5. There are symptoms of cognitive impairment, Montreal Cognitive Assessment scale (Montreal Cognitive Assessment scale, MoCA) \\<26 points\n6. Education level above primary school.\n\nExclusion Criteria:\n\n1. Patients with history of epilepsy or coronary heart disease or other serious unstable physical diseases\n2. Participated in another intervention clinical study in the past 1 month\n3. 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\n4. He has been taking antidepressants, mental retardants and other psychiatric drugs for the past 2 weeks\n5. Severe aphasia, visual and hearing impairment, etc. unable to complete the scale evaluation"}, 'identificationModule': {'nctId': 'NCT05588102', 'briefTitle': 'Electronic Training of Elderly Depression With Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Research on Standardized Electronic Cognitive Training Technique in Early Stage of Senile Depression With Cognitive Impairment', 'orgStudyIdInfo': {'id': 'Z191100006619061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Selective Serotonin Reuptake Inhibitor（SSRIs）combined with Electronic cognitive training', 'description': 'SSRIs（Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram）combined with Electronic cognitive training (60min, once a day)', 'interventionNames': ['Drug: Selective Serotonin Reuptake Inhibitor（SSRIs，Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram）']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'SSRIs antidepressants combined with blank control Electronic training for 52 weeks', '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)', 'interventionNames': ['Drug: Selective Serotonin Reuptake Inhibitor（SSRIs，Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram）']}], 'interventions': [{'name': 'Selective Serotonin Reuptake Inhibitor（SSRIs，Fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram）', 'type': 'DRUG', 'otherNames': ['Electronic cognitive training'], '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)', 'armGroupLabels': ['SSRIs antidepressants combined with blank control Electronic training for 52 weeks', 'Selective Serotonin Reuptake Inhibitor（SSRIs）combined with Electronic cognitive training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Anding Hospital Affiliated to Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Qinge Zhang, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Anding Hospital Affiliated to Capital Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof', 'investigatorFullName': 'Qinge Zhang', 'investigatorAffiliation': 'Capital Medical University'}}}}