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

NCT00140257 | Unknown Phase 4

• 1 other identifier: KF 12-134/04
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Scale

• International Classification of Diseases, Revision 10 (ICD-10) Mood Disorder Diagnosis

Secondary Outcomes (2)

• Cardiac status

• Medical comorbidity

Interventions

Escitalopram DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ACS
• Randomization within 8 weeks form index hospitalization for ACS
• Age \> 18 years
• Not pregnant
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• H. Lundbeck A/S: collaborator
• Danish Heart Foundation: collaborator
• The Danish Medical Research Council: collaborator

Study Sites (1)

Bispebjerg University Hospital

Copenhagen, 2400 NV, Denmark

Location

Related Publications (1)

• Hansen BH, Hanash JA, Rasmussen A, Hansen JF, Birket-Smith M. Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD). Trials. 2009 Apr 7;10:20. doi: 10.1186/1745-6215-10-20.

  PMID: 19351383 DERIVED

MeSH Terms

Conditions

Depression; Myocardial Infarction

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Morten Birket-Smith, MD, DMSci

  Psychiatric Centre Bispebjerg, Bispebjerg University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: November 1, 2004
• Primary Completion: December 1, 2008
• Last Updated: December 31, 2008

Record last verified: 2008-12

Locations

DK (1)