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Sponsors and Collaborators: |
Chonnam National University Hospital H. Lundbeck A/S |
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Information provided by: | Chonnam National University Hospital |
ClinicalTrials.gov Identifier: | NCT00419471 |
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 |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Escitalopram in the Treatment of Depressive Patients With Acute Coronary Artery Syndrome: A Double-Blind Placebo-Controlled Trial |
Estimated Enrollment: | 212 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
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.
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2: Placebo Comparator |
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.
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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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jae-Min Kim, MD & PhD | 82-62-2206143 | jmkim@chonnam.ac.kr |
Contact: Jin-Sang Yoon, MD & PhD | 82-62-2206142 | jsyoon@chonnam.ac.kr |
Korea, Republic of | |
Chonnam National University Hospital | Recruiting |
Gwangju, Korea, Republic of, 501-757 | |
Contact: Jae-Min Kim, MD & PhD 82-62-2206143 jmkim@chonnam.ac.kr | |
Principal Investigator: Jin-Sang Yoon, MD & PhD | |
Sub-Investigator: Myung-Ho Jeong, MD & PhD | |
Sub-Investigator: Jae-Min Kim, MD & PhD |
Principal Investigator: | Jin-Sang Yoon, MD & PhD | Chonnam National University Hospital |
Study Director: | Jae-Min Kim, MD & PhD | Chonnam National University Hospital |
Responsible Party: | Chonnam National University Hospital ( Jin-Sang Yoon / Professor ) |
Study ID Numbers: | LIIS-11592A |
Study First Received: | January 5, 2007 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00419471 |
Health Authority: | Korea: Food and Drug Administration |
Depression Myocardial infarction Angina, unstable |
Arterial Occlusive Diseases Depression Heart Diseases Myocardial Ischemia Angina Pectoris Vascular Diseases Ischemia Arteriosclerosis Depressive Disorder Citalopram |
Serotonin Behavioral Symptoms Coronary Disease Mental Disorders Mood Disorders Dexetimide Infarction Myocardial Infarction Angina, Unstable Coronary Artery Disease |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents Serotonin Uptake Inhibitors |
Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |