Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-04 @ 3:09 PM
Study NCT ID:
NCT00140257
Status:
UNKNOWN
Last Update Posted:
2008-12-31
First Post:
2005-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DECARD: Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089983', 'term': 'Escitalopram'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'lastUpdateSubmitDate': '2008-12-30', 'studyFirstSubmitDate': '2005-08-30', 'studyFirstSubmitQcDate': '2005-08-30', 'lastUpdatePostDateStruct': {'date': '2008-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Depression Scale'}, {'measure': 'International Classification of Diseases, Revision 10 (ICD-10) Mood Disorder Diagnosis'}], 'secondaryOutcomes': [{'measure': 'Cardiac status'}, {'measure': 'Medical comorbidity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myocardial Infarction'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '19351383', 'type': 'DERIVED', 'citation': 'Hansen BH, Hanash JA, Rasmussen A, Hansen JF, Birket-Smith M. Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD). Trials. 2009 Apr 7;10:20. doi: 10.1186/1745-6215-10-20.'}]}, 'descriptionModule': {'briefSummary': 'Objective: To evaluate the efficacy of preventive treatment with a selective serotonin reuptake inhibitor (SSRI) (escitalopram) in the first year after acute coronary syndromes (ACS).\n\nMethods: 240 patients with acute coronary syndromes (ST-elevation myocardial infarction \\[STEMI\\]), non-STEMI or unstable angina) will be enrolled within 8 weeks after ACS and will be randomly assigned to treatment with escitalopram/placebo (5-20 mg) in 52 weeks. Primary outcome measures are the diagnosis of depression and HDS (Hamilton Depression Scale). Psychiatric measurements: SCAN (Schedules for Clinical Assessment in Neuropsychiatry), HDS, HAS (Hamilton Anxiety Rating Scale), Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale, ESSI (Enhancing Recovery in Coronary Heart Disease \\[ENRICHD\\] Social Support Instrument), SF-36 (Short Form-36 Health Survey), SCL-92 (Symptom Check List) and BDI (Beck´s Depression Inventory). Cardiological measurements are blood pressure, electrocardiography, echocardiography (left ventricular ejection fraction), heart rate variability and use of medicine.\n\nDiscussion: ACS patients with mental illness are usually only diagnosed to a very small extent during admission in a cardiologic department. These patients mainly remain untreated with an increased risk of somatic comorbidity and mortality. Therefore, it is in accordance with ethical principles to conduct a double blind, placebo-controlled study investigating the interface between anxiety, depression and ACS. Even in this blinded study, where one of the groups are treated with placebo, there will be a higher degree of treatment of depressive symptoms due to the low recognition of this problem.\n\nConclusion: The DECARD study is the first study evaluating the effect of prophylactic treatment of depression in patients with ACS. The study will show if prophylactic treatment will improve cardiac prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ACS\n* Randomization within 8 weeks form index hospitalization for ACS\n* Age \\> 18 years\n* Not pregnant\n* Signed informed consent\n\nExclusion Criteria:\n\n* Current depression\n* Use of antidepressants \\< 4 weeks\n* Previous intolerance to SSRI\n* Severe medical conditions\n* Severe heart failure\n* Alcohol or substance abuse\n* Psychosis or dementia\n* Current participation in other intervention trials\n* Pregnancy and lactation\n* Linguistic difficulties'}, 'identificationModule': {'nctId': 'NCT00140257', 'briefTitle': 'DECARD: Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'KF 12-134/04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Escitalopram', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400 NV', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Morten Birket-Smith, MD, DMSci', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Psychiatric Centre Bispebjerg, Bispebjerg University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, {'name': 'Danish Heart Foundation', 'class': 'OTHER'}, {'name': 'The Danish Medical Research Council', 'class': 'OTHER'}]}}}