Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Jae-Min Kim, Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT00419471
First received: January 5, 2007
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Depressive Disorder
Coronary Disease
Drug: Escitalopram
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Chonnam National University Hospital:

Primary Outcome Measures:
  • Score on the Hamilton Depression Rating Scale-17 item [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scores on the Beck Depression Inventory [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in electrocardiographic, echocardiographic, and angiographic variables [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Scores on the Montgomery Asberg Depression Rating Scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Scores on the Clinical Global Impression scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Scores on the World Health Organization Quality of Life scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Scores on the Social and Occupational Functioning Assessment Scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Scores on the World Health Organization Disability Assessment Schedule [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: May 2007
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419471

Locations
Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of, 501-757
Sponsors and Collaborators
Chonnam National University Hospital
H. Lundbeck A/S
Investigators
Principal Investigator: Jin-Sang Yoon, MD & PhD Chonnam National University Hospital
Study Director: Jae-Min Kim, MD & PhD Chonnam National University Hospital
  More Information

No publications provided

Responsible Party: Jae-Min Kim, Associate Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT00419471     History of Changes
Other Study ID Numbers: LIIS-11592A
Study First Received: January 5, 2007
Last Updated: June 11, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chonnam National University Hospital:
Depression
Myocardial infarction
Angina, unstable

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Depressive Disorder
Depression
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on April 17, 2014