Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome

Chonnam National University

Status and phase: Completed; Phase 4

Conditions: Coronary Disease; Depressive Disorder

Treatments: Drug: Placebo; Drug: Escitalopram

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00419471

LIIS-11592A

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

Escitalopram

Experimental group

Treatment:

Drug: Escitalopram

Placebo pill

Placebo Comparator group

Treatment:

Drug: Placebo