DECARD: Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome
This trial is active, not recruiting.
|Collaborator||H. Lundbeck A/S|
|Start date||November 2004|
|End date||December 2008|
|Trial size||240 participants|
|Trial identifier||NCT00140257, KF 12-134/04|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Hamilton Depression Scale
International Classification of Diseases, Revision 10 (ICD-10) Mood Disorder Diagnosis
Male or female participants at least 18 years old.
Inclusion Criteria: - ACS - Randomization within 8 weeks form index hospitalization for ACS - Age > 18 years - Not pregnant - Signed informed consent Exclusion Criteria: - Current depression - Use of antidepressants < 4 weeks - Previous intolerance to SSRI - Severe medical conditions - Severe heart failure - Alcohol or substance abuse - Psychosis or dementia - Current participation in other intervention trials - Pregnancy and lactation - Linguistic difficulties
|Official title||A Double-Blind, Placebo-Controlled Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome|
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