Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome

Phase 4

Completed

• Conditions: Coronary Disease; Depressive Disorder
• Interventions: Drug: Placebo; Drug: Escitalopram

• Registration Number: NCT00419471
• Lead Sponsor: Chonnam National University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2007-01-05
• Study First Submitted QC: 2007-01-05
• Study First Posted: 2007-01-08
• Study Start: 2007-05
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-11
• Last Update Posted: 2013-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo pill	Placebo	-
Escitalopram	Escitalopram	-

Primary Outcome Measures

Name	Time	Method
Score on the Hamilton Depression Rating Scale-17 item	24 weeks

Secondary Outcome Measures

Name	Time	Method
Scores on the Beck Depression Inventory	24 weeks
Changes in electrocardiographic, echocardiographic, and angiographic variables	24 weeks
Scores on the Montgomery Asberg Depression Rating Scale	24 weeks
Scores on the World Health Organization Disability Assessment Schedule	24 weeks
Scores on the Clinical Global Impression scale	24 weeks
Scores on the Social and Occupational Functioning Assessment Scale	24 weeks
Scores on the World Health Organization Quality of Life scale	24 weeks

Trial Locations

Locations (1)

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of