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

Depression Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00140257
• Other study ID #: KF 12-134/04
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 30, 2005
• Last updated: December 30, 2008
• Start date: November 2004

Study information

• Verified date: December 2008
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Depression
• Depressive Disorder

Intervention

Drug:
• Escitalopram

Locations

Country	Name	City	State
Denmark	Bispebjerg University Hospital	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Danish Heart Foundation, H. Lundbeck A/S, The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Scale
Primary	International Classification of Diseases, Revision 10 (ICD-10) Mood Disorder Diagnosis
Secondary	Cardiac status
Secondary	Medical comorbidity