Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome - Full Text View

Sponsor:	Chonnam National University Hospital
Collaborator:	H. Lundbeck A/S
Information provided by:	Chonnam National University Hospital
ClinicalTrials.gov Identifier:	NCT00419471

Purpose

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

Condition	Intervention	Phase
Depressive Disorder Coronary Disease	Drug: Escitalopram Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Escitalopram in the Treatment of Depressive Patients With Acute Coronary Artery Syndrome: A Double-blind Placebo-controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Chonnam National University Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	212
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Escitalopram: Experimental	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.
Placebo pill: Placebo Comparator	Drug: Placebo Placebo medication will be provided as matched 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day.

Arms

Assigned Interventions

Escitalopram: Experimental

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.

Placebo pill: Placebo Comparator

Drug: Placebo

Placebo medication will be provided as matched 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day.

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419471

Contacts

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

Locations

Korea, Republic of
Chonnam National University Hospital	Recruiting
Gwangju, Korea, Republic of, 501-757
Contact: Jae-Min Kim, MD & PhD 82-62-2206143 jmkim@chonnam.ac.kr
Principal Investigator: Jin-Sang Yoon, MD & PhD
Sub-Investigator: Myung-Ho Jeong, MD & PhD
Sub-Investigator: Jae-Min Kim, MD & PhD

Sponsors and Collaborators

Chonnam National University Hospital

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

More Information

No publications provided

Responsible Party:	Chonnam National University Hospital ( Jin-Sang Yoon / Professor )
Study ID Numbers:	LIIS-11592A
Study First Received:	January 5, 2007
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00419471 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Chonnam National University Hospital:

Depression
Myocardial infarction
Angina, unstable

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Myocardial Ischemia
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Arteriosclerosis
Cholinergic Agents
Pathologic Processes
Mental Disorders
Syndrome

Therapeutic Uses
Cardiovascular Diseases
Antidepressive Agents, Second-Generation
Dexetimide
Antidepressive Agents
Arterial Occlusive Diseases
Heart Diseases
Depression
Disease
Vascular Diseases
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 09, 2009