Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419471
• Other study ID #: LIIS-11592A
• Status: Completed
• Phase: Phase 4
• First received: January 5, 2007
• Last updated: June 11, 2013
• Start date: May 2007
• Est. completion date: March 2013

Study information

• Verified date: June 2013
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju

Sponsors (2)

Lead Sponsor	Collaborator
Chonnam National University Hospital	H. Lundbeck A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the Hamilton Depression Rating Scale-17 item		24 weeks	No
Secondary	Scores on the Beck Depression Inventory		24 weeks	No
Secondary	Changes in electrocardiographic, echocardiographic, and angiographic variables		24 weeks	Yes
Secondary	Scores on the Montgomery Asberg Depression Rating Scale		24 weeks	No
Secondary	Scores on the Clinical Global Impression scale		24 weeks	No
Secondary	Scores on the World Health Organization Quality of Life scale		24 weeks	No
Secondary	Scores on the Social and Occupational Functioning Assessment Scale		24 weeks	No
Secondary	Scores on the World Health Organization Disability Assessment Schedule		24 weeks	No