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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
H. Lundbeck A/S
Danish Heart Foundation
The Danish Medical Research Council
Information provided by:
Bispebjerg Hospital

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Hamilton Depression Scale
  2. International Classification of Diseases, Revision 10 (ICD-10) Mood Disorder Diagnosis

Secondary Outcome Measures :
  1. Cardiac status
  2. Medical comorbidity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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
Sponsors and Collaborators
Bispebjerg Hospital
H. Lundbeck A/S
Danish Heart Foundation
The Danish Medical Research Council
Study Director: Morten Birket-Smith, MD, DMSci Psychiatric Centre Bispebjerg, Bispebjerg University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00140257     History of Changes
Other Study ID Numbers: KF 12-134/04
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: December 31, 2008
Last Verified: December 2008

Keywords provided by Bispebjerg Hospital:
Myocardial Infarction

Additional relevant MeSH terms:
Depressive Disorder
Acute Coronary Syndrome
Behavioral Symptoms
Mood Disorders
Mental Disorders
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents