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

Condition(s) targeted: Depression

Intervention: Escitalopram (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Bispebjerg Hospital

Official(s) and/or principal investigator(s):
Morten Birket-Smith, MD, DMSci, Study Director, Affiliation: Dept. of Psychiatry, Bispebjerg University Hospital

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: 266 patients with acute coronary syndromes (ST-elevation myocardial infarction [STEMI]), non-STEMI or unstable angina) will be enrolled within 4 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.

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

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Hamilton Depression Scale

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

Secondary outcome:

Cardiac status

Medical comorbidity

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Myocardial infarction [C14. 907. 553. 470. 500]

- Inclusion within 4 weeks after cardiac event

- Age > 18 years

- HDS < 13

- Not pregnant

Exclusion Criteria:

- Major medical or mental illness

- HDS > 26

- Suicidal

- Use of antidepressants < 4 weeks

- Current alcohol/drug abuse

- Pregnancy

- Previously included in the trial

- No fluency in Danish

Bispebjerg University Hospital, Copenhagen 2400 NV, Denmark

Starting date: November 2004
Last updated: January 14, 2008