Official Title: “Efficacy and Safety of Escitalopram in the Treatment of Depressive Patients With Acute Coronary Artery Syndrome: A Double-Blind Placebo-Controlled Trial”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2011

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.

Intervention(s) in this Clinical Trial

• Drug: Escitalopram
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Score on the Hamilton Depression Rating Scale-17 item
  • Time Frame: 24 weeks
    Safety Issue?: No

Secondary Measures

• Scores on the BDI, MADRS, CGI, WHOQOL, SOFAS, WHODAS
  • Time Frame: 24 weeks
    Safety Issue?: No
• Changes in electrocardiographic, echocardiographic, and angiographic variables
  • Time Frame: 24 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Chonnam National University Hospital

Overall Clinical Trial Officials and Contacts

Jin-Sang Yoon, MD & PhD Principal Investigator Chonnam National University Hospital  

Overall Contact: Jae-Min Kim, MD & PhD 82-62-2206143 jmkim@chonnam.ac.kr

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00419471

Study ID Number: LIIS-11592A

ClinicalTrials.gov Identifier: NCT00419471

Health Authority: Korea: Food and Drug Administration