Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome
Information source: Chonnam National University Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depressive Disorder; Coronary Disease
Intervention: Escitalopram (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Chonnam National University Hospital Official(s) and/or principal investigator(s):
Jin-Sang Yoon, MD & PhD, Principal Investigator, Affiliation: Chonnam National University Hospital
Jae-Min Kim, MD & PhD, Study Director, Affiliation: Chonnam National University Hospital
Overall contact:
Jae-Min Kim, MD & PhD, Phone: 82-62-2206143, Email: jmkim@chonnam.ac.kr
Summary
This study aimed to evaluate the efficacy and safety of escitalopram in the treatment of
depressive patients with acute coronary artery syndrome (CAS).
Clinical Details
Official title: Efficacy and Safety of Escitalopram in the Treatment of Depressive Patients With Acute Coronary Artery Syndrome: A Double-Blind Placebo-Controlled Trial
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Score on the Hamilton Depression Rating Scale-17 item
Secondary outcome: Scores on the BDI, MADRS, CGI, WHOQOL, SOFAS, WHODASChanges in electrocardiographic, echocardiographic, and angiographic variables
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
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Jae-Min Kim, MD & PhD, Phone: 82-62-2206143, Email: jmkim@chonnam.ac.kr
Chonnam National University Hospital, Gwangju 501-757, Korea, Republic of; Recruiting
Jae-Min Kim, MD & PhD, Phone: 82-62-2206143, Email: jmkim@chonnam.ac.kr
Jin-Sang Yoon, MD & PhD, Principal Investigator
Myung-Ho Jeong, MD & PhD, Sub-Investigator
Jae-Min Kim, MD & PhD, Sub-Investigator
Additional Information
Starting date: May 2007
Ending date: December 2011
Last updated: May 19, 2008
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