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Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome

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ClinicalTrials.gov Identifier: NCT00419471
Recruitment Status : Completed
First Posted : January 8, 2007
Last Update Posted : June 13, 2013
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Jae-Min Kim, Chonnam National University Hospital

Tracking Information
First Submitted Date  ICMJE January 5, 2007
First Posted Date  ICMJE January 8, 2007
Last Update Posted Date June 13, 2013
Study Start Date  ICMJE May 2007
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2007)
Score on the Hamilton Depression Rating Scale-17 item [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2007)
Score on the Hamilton Depression Rating Scale-17 item at 24 weeks
Change History Complete list of historical versions of study NCT00419471 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2013)
  • Scores on the Beck Depression Inventory [ Time Frame: 24 weeks ]
  • Changes in electrocardiographic, echocardiographic, and angiographic variables [ Time Frame: 24 weeks ]
  • Scores on the Montgomery Asberg Depression Rating Scale [ Time Frame: 24 weeks ]
  • Scores on the Clinical Global Impression scale [ Time Frame: 24 weeks ]
  • Scores on the World Health Organization Quality of Life scale [ Time Frame: 24 weeks ]
  • Scores on the Social and Occupational Functioning Assessment Scale [ Time Frame: 24 weeks ]
  • Scores on the World Health Organization Disability Assessment Schedule [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2007)
  • Scores on the BDI, MADRS, CGI, WHOQOL, SOFAS, WHODAS at 24 weeks
  • Changes in electrocardiographic, echocardiographic, and angiographic variables
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome
Official Title  ICMJE Efficacy and Safety of Escitalopram in the Treatment of Depressive Patients With Acute Coronary Artery Syndrome: A Double-blind Placebo-controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depressive Disorder
  • Coronary Disease
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Placebo medication will be provided as matched 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day.
Study Arms  ICMJE
  • Experimental: Escitalopram
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo pill
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2013)
300
Original Enrollment  ICMJE
 (submitted: January 5, 2007)
212
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00419471
Other Study ID Numbers  ICMJE LIIS-11592A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jae-Min Kim, Chonnam National University Hospital
Study Sponsor  ICMJE Chonnam National University Hospital
Collaborators  ICMJE H. Lundbeck A/S
Investigators  ICMJE
Principal Investigator: Jin-Sang Yoon, MD & PhD Chonnam National University Hospital
Study Director: Jae-Min Kim, MD & PhD Chonnam National University Hospital
PRS Account Chonnam National University Hospital
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP