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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 Inventory

Changes 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

Page last updated: August 23, 2015

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