Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

January 5, 2007

Last Updated Date

July 31, 2009

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Score on the Hamilton Depression Rating Scale-17 item [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Score on the Hamilton Depression Rating Scale-17 item at 24 weeks

Change History

Complete list of historical versions of study NCT00419471 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Scores on the BDI, MADRS, CGI, WHOQOL, SOFAS, WHODAS [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Changes in electrocardiographic, echocardiographic, and angiographic variables [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Scores on the BDI, MADRS, CGI, WHOQOL, SOFAS, WHODAS at 24 weeks
Changes in electrocardiographic, echocardiographic, and angiographic variables

Descriptive Information

Brief Title ^ICMJE

Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome

Official Title ^ICMJE

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

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Depressive Disorder
Coronary Disease

Intervention ^ICMJE

Drug: Escitalopram
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

212

Estimated Completion Date

December 2011

Estimated Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jae-Min Kim, MD & PhD	82-62-2206143	jmkim@chonnam.ac.kr
Contact: Jin-Sang Yoon, MD & PhD	82-62-2206142	jsyoon@chonnam.ac.kr

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT ID ^ICMJE

NCT00419471

Responsible Party

Jin-Sang Yoon / Professor, Chonnam National University Hospital

Study ID Numbers ^ICMJE

LIIS-11592A

Study Sponsor ^ICMJE

Chonnam National University Hospital

Collaborators ^ICMJE

H. Lundbeck A/S

Investigators ^ICMJE

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

Information Provided By

Chonnam National University Hospital

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP