Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome
Information source: Chonnam National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depressive Disorder; Coronary Disease
Intervention: Escitalopram (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
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
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Score on the Hamilton Depression Rating Scale-17 item
Secondary outcome: Scores on the Beck Depression InventoryChanges in electrocardiographic, echocardiographic, and angiographic variables Scores on the Montgomery Asberg Depression Rating Scale Scores on the Clinical Global Impression scale Scores on the World Health Organization Quality of Life scale Scores on the Social and Occupational Functioning Assessment Scale Scores on the World Health Organization Disability Assessment Schedule
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
Chonnam National University Hospital, Gwangju 501-757, Korea, Republic of
Additional Information
Starting date: May 2007
Last updated: June 11, 2013
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