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Completed

NCT Number: NCT00419471

Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome

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

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Key information

Conditions

Depressive Disorder Angina Pectoris Angina, Unstable Behavior Behavioral Symptoms Cardiovascular Diseases Chest Pain Coronary Disease Depression Heart Diseases Infarction Ischemia Mental Disorders Mood Disorders Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chonnam National University Hospital

Gwangju, 501-757, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escitalopram

Drug

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.

Other names: Lexapro, Cipralex

Placebo

Drug

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

Primary outcomes

  1. Score on the Hamilton Depression Rating Scale-17 item

    Time frame: 24 weeks

Secondary outcomes

  1. Scores on the Beck Depression Inventory

    Time frame: 24 weeks

  2. Changes in electrocardiographic, echocardiographic, and angiographic variables

    Time frame: 24 weeks

  3. Scores on the Montgomery Asberg Depression Rating Scale

    Time frame: 24 weeks

  4. Scores on the Clinical Global Impression scale

    Time frame: 24 weeks

  5. Scores on the World Health Organization Quality of Life scale

    Time frame: 24 weeks

  6. Scores on the Social and Occupational Functioning Assessment Scale

    Time frame: 24 weeks

  7. Scores on the World Health Organization Disability Assessment Schedule

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Collaborators

  • H. Lundbeck A/S

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jan 8, 2007
Registry last updated
Jun 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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