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Sponsors and Collaborators: |
Bispebjerg Hospital H. Lundbeck A/S The Danish Heart Association The Danish Medical Research Council |
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Information provided by: | Bispebjerg Hospital |
ClinicalTrials.gov Identifier: | NCT00140257 |
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).
Methods: 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.
Discussion: 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.
Conclusion: 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.
Condition | Intervention | Phase |
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Depression |
Drug: Escitalopram |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome |
Enrollment: | 240 |
Study Start Date: | November 2004 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Bispebjerg University Hospital | |
Copenhagen, Denmark, 2400 NV |
Study Director: | Morten Birket-Smith, MD, DMSci | Psychiatric Centre Bispebjerg, Bispebjerg University Hospital |
Study ID Numbers: | KF 12-134/04 |
Study First Received: | August 30, 2005 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00140257 |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Myocardial Infarction |
Depression Heart Diseases Myocardial Ischemia Vascular Diseases Ischemia Depressive Disorder Citalopram Serotonin |
Behavioral Symptoms Mental Disorders Acute Coronary Syndrome Mood Disorders Infarction Dexetimide Myocardial Infarction |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents Serotonin Uptake Inhibitors |
Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |