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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bispebjerg Hospital
• Collaborators: Danish Heart Foundation; H. Lundbeck A/S; The Danish Medical Research Council
• Treatments: Citalopram; Dexetimide

Criteria

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