Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-29 @ 12:44 PM
Study NCT ID:
NCT01952366
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2013-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prognosis of Depression in the Elderly (PRODE). A Multicentre, Longitudinal Study of Elderly Depressed Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tom.borza@sykehuset-innlandet.no', 'phone': '+47 91834607', 'title': 'Dr. Tom Borza', 'organization': 'Sykehuset Innlandet'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "The study's recruitment is finished. Analyses are ongoing from the one-year and three-year follow-up"}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Depressed Patients', 'description': 'Patients admitted to specialist health care service of old age psychiatry', 'otherNumAtRisk': 169, 'otherNumAffected': 0, 'seriousNumAtRisk': 169, 'seriousNumAffected': 0}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Response in Depressed Patients', 'description': 'Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a response (50% improvement of the MADRS score) during stay in the hospital.'}, {'id': 'OG001', 'title': 'Remission in Depressed Patients', 'description': 'Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a remission (MADRS score of 9 or less) by the end of their hospital stay.'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Patients were follow during their stay in the hospital; average days of stay in hospital = 68.3 (SD=46.8)', 'description': 'Response (50% improvement on the Montgomery and Asberg Depression Rating Scale (MADRS) score) Remission (defined as score of 9 or less on the MADRS)\n\nThe MADRS is a measurement of the severity of depression and consists of 10 items rated from 0 points (no symptoms) to 6 (severe symptoms)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with complete MADRS records'}, {'type': 'PRIMARY', 'title': 'Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Depressed Patients', 'description': 'Patients admitted to specialist health care service of old age psychiatry'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year after inclusion to the study', 'description': 'Relapse/recurrence of depression', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Inpatients'}, {'type': 'SECONDARY', 'title': 'Number of Patients With a Diagnosis of Dementia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient With Dementia One Year After Inclusion to the Study', 'description': 'Number of patients admitted to specialist health care service of old age psychiatry who were diagnosed with dementia one year after inclusion to the study'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year after inclusion to the study', 'description': 'One year after inclusion to the study, there will be a clinical assessment of the patient including a MMSE, if possible, and to evaluate if the patients have dementia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Depressed Patients', 'description': 'Patients admitted to specialist health care service of old age psychiatry'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Depressed Patients', 'description': 'Patients admitted to specialist health care service of old age psychiatry'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '163', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76.1', 'spread': '6.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '123', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Norway', 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Apolipoprotein E polymorphism'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2013-09-24', 'resultsFirstSubmitDate': '2016-04-18', 'studyFirstSubmitQcDate': '2013-09-26', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-02', 'studyFirstPostDateStruct': {'date': '2013-09-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'Patients were follow during their stay in the hospital; average days of stay in hospital = 68.3 (SD=46.8)', 'description': 'Response (50% improvement on the Montgomery and Asberg Depression Rating Scale (MADRS) score) Remission (defined as score of 9 or less on the MADRS)\n\nThe MADRS is a measurement of the severity of depression and consists of 10 items rated from 0 points (no symptoms) to 6 (severe symptoms)'}, {'measure': 'Depression', 'timeFrame': '1 year after inclusion to the study', 'description': 'Relapse/recurrence of depression'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With a Diagnosis of Dementia', 'timeFrame': '1 year after inclusion to the study', 'description': 'One year after inclusion to the study, there will be a clinical assessment of the patient including a MMSE, if possible, and to evaluate if the patients have dementia.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aged', 'Depression', 'Cognition', 'Longitudinal study'], 'conditions': ['Depression', 'Dementia']}, 'referencesModule': {'references': [{'pmid': '26242794', 'type': 'DERIVED', 'citation': 'Borza T, Engedal K, Bergh S, Benth JS, Selbaek G. The course of depression in late life as measured by the Montgomery and Asberg Depression Rating Scale in an observational study of hospitalized patients. BMC Psychiatry. 2015 Aug 5;15:191. doi: 10.1186/s12888-015-0577-8.'}]}, 'descriptionModule': {'briefSummary': 'PRODE is a Norwegian multicentre study investigating the prognosis of depression in the elderly. The study has included 169 patients who will be followed with assessments after one and three years.\n\nThe study hypothesis is that elderly patients referred to specialist health service have a poor long term prognosis.', 'detailedDescription': "Objective: Depression in the elderly is difficult to treat and is often of chronic or recurrent nature. There is little knowledge about the course and the risk factors for recurrence of depression among elderly people in Norway. The aim of the PRODE-study is to examine the short- and long-term prognosis of elderly depressed patients who are referred for treatment in departments of old age psychiatry.\n\nMethod: PRODE is a multicentre case-control and longitudinal study of elderly (\\>60 years) depressed and non-depressed patients with a one and three year follow-up. Nine participating departments of old age psychiatry used the same standardized instruments to collect data of the patients on depression and other mental health issues, cognition, physical health, medications, functions in activities of daily living, quality of life and family carers' situation. The included patients and controls underwent an MRI scan of the brain according to a comprehensive protocol developed for this project. Furthermore, blood and saliva from the included patients are stored in a Biobank for analyses of pro- and anti-inflammatory cytokines and cortisol.\n\nThe study included 169 patients (December 2009-January 2013) and will include the same number of non-depressed controls.\n\nOutcome Measures (short-term):\n\n* Depression as measured with the Montgomery and Asberg Depression Rating Scale (MADRS), Cornell Scale for Depression in Dementia (CSDD) and Hospital Anxiety and Depression Scale (HADS), trajectories and clinical assessments.\n* Function in activities of daily living\n\nOutcome measures (long-term):\n\n* Cognition as measured by Mini Mental State Examination (MMSE) and diagnosis of dementia.\n* Depression, recurrence of depression and as measured wtih the MADRS and CSDD.\n* Use of health care facilities; nursing home.\n* Mortality\n* Function in activities of daily living"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly (\\>60 years) depressed patients referred to treatment at specialist helth care service in Norway.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with depression referred to treatment at specialist health care in Norway.\n* Patients above 60 years\n\nExclusion Criteria:\n\n\\- Demented patients with severe aphasia and patients with life threatening diseases will be excluded'}, 'identificationModule': {'nctId': 'NCT01952366', 'acronym': 'PRODE', 'briefTitle': 'Prognosis of Depression in the Elderly (PRODE). A Multicentre, Longitudinal Study of Elderly Depressed Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Sykehuset Innlandet HF'}, 'officialTitle': 'Prognosis of Depression in the Elderly (PRODE)', 'orgStudyIdInfo': {'id': 'PRODE-2013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Depressed patients', 'description': 'Patients admitted to specialist health care service of old age psychiatry'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2315', 'city': 'Ottestad', 'country': 'Norway', 'facility': 'Innlandet Hospital Trust', 'geoPoint': {'lat': 60.74743, 'lon': 11.1366}}], 'overallOfficials': [{'name': 'Geir Selbaek, MD/Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian Centre for Ageing and Health'}, {'name': 'Tom Borza, MD/PhD cand', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Innlandet Hospital Trust (Sykehuset Innlandet HF)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sykehuset Innlandet HF', 'class': 'OTHER'}, 'collaborators': [{'name': 'South-Eastern Norway Regional Health Authority', 'class': 'OTHER'}, {'name': 'Norwegian Centre for Ageing and Health', 'class': 'OTHER'}, {'name': 'Leagacy of Josef and Haldis Andresen', 'class': 'UNKNOWN'}, {'name': "Solveig and Johan P's Foundation for Psychiatric Research", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}