DECARD: Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome
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|ClinicalTrials.gov Identifier: NCT00140257|
Recruitment Status : Unknown
Verified December 2008 by Bispebjerg Hospital.
Recruitment status was: Active, not recruiting
First Posted : September 1, 2005
Last Update Posted : December 31, 2008
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 or disease||Intervention/treatment||Phase|
|Depression||Drug: Escitalopram||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Double-Blind, Placebo-Controlled Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome|
|Study Start Date :||November 2004|
|Estimated Primary Completion Date :||December 2008|
- Hamilton Depression Scale
- International Classification of Diseases, Revision 10 (ICD-10) Mood Disorder Diagnosis
- Cardiac status
- Medical comorbidity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140257
|Bispebjerg University Hospital|
|Copenhagen, Denmark, 2400 NV|
|Study Director:||Morten Birket-Smith, MD, DMSci||Psychiatric Centre Bispebjerg, Bispebjerg University Hospital|