Efficacy and Safety of Escitalopram in the Treatment of Depressive Patients With Acute Coronary Artery Syndrome: A Double-blind Placebo-controlled Trial

Chonnam National University Hospital1 site in 1 country300 target enrollmentMay 2007

ConditionsDepressive Disorder Coronary Disease

InterventionsEscitalopram Placebo

DrugsEscitalopram Placebo

Overview

Phase: Phase 4
Intervention: Escitalopram
Conditions: Depressive Disorder
Sponsor: Chonnam National University Hospital
Enrollment: 300
Locations: 1
Primary Endpoint: Score on the Hamilton Depression Rating Scale-17 item
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2007

End Date

March 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chonnam National University Hospital

Responsible Party

Principal Investigator

Jae-Min Kim

Associate Professor

Chonnam National University Hospital

Eligibility Criteria

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

Arms & Interventions

Escitalopram

Intervention: Escitalopram

Placebo pill

Intervention: Placebo

Outcomes

Primary Outcomes

Score on the Hamilton Depression Rating Scale-17 item

Time Frame: 24 weeks

Secondary Outcomes

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)