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:
Participant gender:
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
Details
Lead Sponsor:
Bispebjerg Hospital
Collaborators:
Danish Heart Foundation H. Lundbeck A/S The Danish Medical Research Council