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Trial record 1 of 1 for:    NCT00419471
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Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00419471
Recruitment Status : Completed
First Posted : January 8, 2007
Last Update Posted : June 13, 2013
H. Lundbeck A/S
Information provided by (Responsible Party):
Jae-Min Kim, Chonnam National University Hospital

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).

Condition or disease Intervention/treatment Phase
Depressive Disorder Coronary Disease Drug: Escitalopram Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2007
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Escitalopram 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.
Other Names:
  • Lexapro
  • Cipralex

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

Primary Outcome Measures :
  1. Score on the Hamilton Depression Rating Scale-17 item [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00419471

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Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of, 501-757
Sponsors and Collaborators
Chonnam National University Hospital
H. Lundbeck A/S
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Principal Investigator: Jin-Sang Yoon, MD & PhD Chonnam National University Hospital
Study Director: Jae-Min Kim, MD & PhD Chonnam National University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Jae-Min Kim, Associate Professor, Chonnam National University Hospital Identifier: NCT00419471    
Other Study ID Numbers: LIIS-11592A
First Posted: January 8, 2007    Key Record Dates
Last Update Posted: June 13, 2013
Last Verified: June 2013
Keywords provided by Jae-Min Kim, Chonnam National University Hospital:
Myocardial infarction
Angina, unstable
Additional relevant MeSH terms:
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Coronary Disease
Depressive Disorder
Mood Disorders
Mental Disorders
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs