Coronary Disease, Depressive Disorder
Conditions
Keywords
Depression, Myocardial infarction, Angina, unstable
Brief summary
This study aimed to evaluate the efficacy and safety of escitalopram in the treatment of depressive patients with acute coronary artery syndrome (CAS).
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.
Interventions
DRUGEscitalopram
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.
DRUGPlacebo
Placebo medication will be provided as matched 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day.
Sponsors
H. Lundbeck A/S
Chonnam National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score on the Hamilton Depression Rating Scale-17 item | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Scores on the Beck Depression Inventory | 24 weeks |
| Changes in electrocardiographic, echocardiographic, and angiographic variables | 24 weeks |
| Scores on the Montgomery Asberg Depression Rating Scale | 24 weeks |
| Scores on the World Health Organization Disability Assessment Schedule | 24 weeks |
| Scores on the World Health Organization Quality of Life scale | 24 weeks |
| Scores on the Social and Occupational Functioning Assessment Scale | 24 weeks |
| Scores on the Clinical Global Impression scale | 24 weeks |
Countries
South Korea
Outcome results
None listed