Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-29 @ 12:57 PM
Study NCT ID:
NCT00818506
Status:
COMPLETED
Last Update Posted:
2012-11-21
First Post:
2009-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Associations Between Depression and Cardiovascular Disease - a Study of Patients With Late Onset Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-20', 'studyFirstSubmitDate': '2009-01-06', 'studyFirstSubmitQcDate': '2009-01-06', 'lastUpdatePostDateStruct': {'date': '2012-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-07', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'Major depressive disorder', 'Coronary artery disease', 'White Matter Hyperintensities', 'White Matter Lesions', 'Coronary artery calcification'], 'conditions': ['Depression', 'Major Depressive Disorder', 'Cardiovascular Disease', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Studies show that depression is a risk factor for the development of coronary artery disease (CAD). Furthermore there is an increased occurrence of depression in patients with CAD. Among other mechanisms atherosclerosis is believed to play a central role regarding these notable associations between depression and CAD. Moreover, patients with late onset major depression have an increased number of small lesions found in the white matter of the brain, the so-called white matter lesions. The main goal of this project is to examine if CAD is associated with depression and/or white matter lesions. CAD is evaluated using coronary CT angiography. Depression is evaluated using a semi-structured diagnostic interview. White matter lesions are quantified using cerebral magnetic resonance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Psychiatric treatment facilities (e.g. psychiatric hospital, private psychiatrist).', 'healthyVolunteers': True, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* Submitted to psychiatric hospital, district psychiatry or private psychiatrist because of major depressive disorder.\n* Meets the criteria for Major Depressive Disorder, Single Episode as defined in the Diagnostic and Statistical Manual, fourth edition (DSM-IV) and the International Classification of Diseases (ICD-10).\n* Age 50-70 years.\n* Written informed consent.\n* Caucasian.\n\nEXCLUSION CRITERIA:\n\n* Known, or anamnestic/objective signs of, organic brain disease.\n* Organic, including symptomatic, mental disorders as (ICD-10: F00-F09).\n* Dependence syndrome within the last 5 years (ICD-10: F1x.2) or current harmful use (ICD-10: F1x.1) of alcohol or other psychoactive substances.\n* Schizophrenia, schizotypal and delusional disorders (ICD-10: F20-F29).\n* Subject to force of law according to the danish law on psychiatry.\n* Present risk of suicide.\n* Previous cranial trauma resulting in unconsciousness for more than 2 minutes.\n* Medical history of renal failure.\n* Other conditions which contraindicate specific procedures in the project.\n* Other conditions deemed to prevent the subject from completing the examination program.\n* Does not want to participate.'}, 'identificationModule': {'nctId': 'NCT00818506', 'briefTitle': 'Associations Between Depression and Cardiovascular Disease - a Study of Patients With Late Onset Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Associations Between Depression and Cardiovascular Disease in Patients With Late Onset, Single Episode Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'CPF-TAD-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Late onset MDD', 'description': 'Patients with major depressive disorder between 50 and 70 years of age that did not suffer from depression before the age of 50.'}, {'label': 'Controls', 'description': 'Healthy controls (matched for age, sex, and tobacco use status)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Center of Psychiatric Research, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Poul Videbech, Professor, M.D., Dr.Med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Center of Psychiatric Research, Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Ministry of Science, Technology and Innovation, Denmark', 'class': 'OTHER_GOV'}, {'name': 'Vejle Hospital', 'class': 'OTHER'}, {'name': 'Danish National Research Foundation', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Augustinus Fonden', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}