Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome

Phase 4CompletedNCT00419471

Chonnam National University Hospital300 enrolled

Overview

This study aimed to evaluate the efficacy and safety of escitalopram in the treatment of depressive patients with acute coronary artery syndrome (CAS).

Depression is common in patients with acute CAS and increases cardiac morbidity and mortality. However, there are a few limited data available regarding the effects and safety of antidepressants for treating depression in patients with acute CAS. This study aims to investigate whether escitalopram might be an effective treatment option for these patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

300

Conditions

Depressive Disorder Coronary Disease

Interventions

EscitalopramDRUG

Study medication will be provided as 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day, and matched placebo. The initial dose of escitalopram was 10mg/day generally, but 5mg/day for those aged 65 or over and with hepatic dysfunction. After the 2nd evaluation, the treatment doses are determined by the investigators' clinical decision considering the severity of depression and tolerability of drug. Drugs are taken once daily per orally within 30 min after the supper meal.

PlaceboDRUG

Placebo medication will be provided as matched 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 18\~85 * Diagnosed as acute CAS (unstable angina or acute myocardial infarction) and being conducted coronary angiography * Beck Depression Inventory \> 10 and major or minor depressive disorder by the DSM-IV criteria * With ability to complete various questionnaires * Can understand the objective of the study and sign informed consent Exclusion Criteria: * Occurrence of acute CAS while the patient was hospitalized for another reason, except for CAS * Current CAS developed less than 3 months after coronary artery bypass graft procedure * Uncontrolled hypertension (systolic BP \> 180mmHg or diastolic BP \> 100mmHg) * Resting heart rate \< 40/min * Severe physical illnesses threatening life or interfering with the recovery from CAS * Persistent clinically significant laboratory abnormalities * Concomitant use of class I antiarrhythmic medications; reserpine, guanethidine, clonidine, or methyldopa; anticonvulsants or neuroleptics * History of neuropsychiatric illnesses such as dementia, Parkinson's disease, brain tumor, psychoses, alcoholism, and other substance dependence * Pregnancy

Locations (1)

Chonnam National University Hospital

Gwangju, South Korea

Outcomes

Primary Outcomes

Score on the Hamilton Depression Rating Scale-17 item

Time frame: 24 weeks

Secondary Outcomes

Scores on the Beck Depression Inventory

Time frame: 24 weeks

Changes in electrocardiographic, echocardiographic, and angiographic variables

Time frame: 24 weeks

Scores on the Montgomery Asberg Depression Rating Scale

Time frame: 24 weeks

Scores on the Clinical Global Impression scale

Time frame: 24 weeks

Scores on the World Health Organization Quality of Life scale

Time frame: 24 weeks

Scores on the Social and Occupational Functioning Assessment Scale

Time frame: 24 weeks

Scores on the World Health Organization Disability Assessment Schedule

Time frame: 24 weeks

Data from ClinicalTrials.gov

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