Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome

June 11, 2013 updated by: Jae-Min Kim, Chonnam National University Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Gwangju, Korea, Republic of, 501-757
        • Chonnam National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Escitalopram
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.
Other Names:
  • Cipralex
  • Lexapro
Placebo Comparator: Placebo pill
Drug: Placebo
Placebo medication will be provided as matched 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score on the Hamilton Depression Rating Scale-17 item
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonnam National University Hospital

Collaborators

H. Lundbeck A/S

Investigators

  • Principal Investigator: Jin-Sang Yoon, MD & PhD, Chonnam National University Hospital
  • Study Director: Jae-Min Kim, MD & PhD, Chonnam National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 5, 2007

First Submitted That Met QC Criteria

January 5, 2007

First Posted (Estimate)

January 8, 2007

Study Record Updates

Last Update Posted (Estimate)

June 13, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIIS-11592A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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