DECARD: Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Bispebjerg Hospital.
Recruitment status was  Active, not recruiting
H. Lundbeck A/S
Danish Heart Foundation
The Danish Medical Research Council
Information provided by:
Bispebjerg Hospital Identifier:
First received: August 30, 2005
Last updated: December 30, 2008
Last verified: December 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 Intervention Phase
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Double-Blind, Placebo-Controlled Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome

Resource links provided by NLM:

Further study details as provided by Bispebjerg Hospital:

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

Secondary Outcome Measures:
  • Cardiac status
  • Medical comorbidity

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:

  • 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
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Please refer to this study by its identifier: 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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00140257     History of Changes
Other Study ID Numbers: KF 12-134/04 
Study First Received: August 30, 2005
Last Updated: December 30, 2008
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Bispebjerg Hospital:
Myocardial Infarction

Additional relevant MeSH terms:
Acute Coronary Syndrome
Depressive Disorder
Behavioral Symptoms
Cardiovascular Diseases
Heart Diseases
Mental Disorders
Mood Disorders
Myocardial Ischemia
Vascular Diseases
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors processed this record on May 25, 2016