Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome
NCT ID: NCT00419471
Last Updated: 2013-06-13
Study Results
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Basic Information
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COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2007-05-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Escitalopram
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.
Placebo pill
Placebo
Placebo medication will be provided as matched 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day.
Interventions
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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.
Placebo
Placebo medication will be provided as matched 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Chonnam National University Hospital
OTHER
Responsible Party
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Jae-Min Kim
Associate Professor
Principal Investigators
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Jin-Sang Yoon, MD & PhD
Role: PRINCIPAL_INVESTIGATOR
Chonnam National University Hospital
Jae-Min Kim, MD & PhD
Role: STUDY_DIRECTOR
Chonnam National University Hospital
Locations
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Chonnam National University Hospital
Gwangju, , South Korea
Countries
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References
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Choi W, Kim JW, Kang HJ, Kim HK, Kang HC, Lee JY, Kim SW, Hong YJ, Ahn Y, Jeong MH, Stewart R, Kim JM. Interaction effects of diabetes and brain-derived neurotrophic factor on suicidal ideation in patients with acute coronary syndrome. Sci Rep. 2022 Apr 22;12(1):6602. doi: 10.1038/s41598-022-10557-6.
Kim JW, Stewart R, Lee HJ, Kang HJ, Kim SW, Shin IS, Kim MC, Hong YJ, Ahn YK, Jeong MH, Yoon JS, Kim JM. Sleep problems associated with long-term mortality in acute coronary syndrome: Effects of depression comorbidity and treatment. Gen Hosp Psychiatry. 2020 Sep-Oct;66:125-132. doi: 10.1016/j.genhosppsych.2020.08.004. Epub 2020 Aug 13.
Kim JM, Stewart R, Kang HJ, Kim SY, Kim JW, Lee HJ, Lee JY, Kim SW, Shin IS, Kim MC, Shin HY, Hong YJ, Ahn Y, Jeong MH, Yoon JS. Long-term cardiac outcomes of depression screening, diagnosis and treatment in patients with acute coronary syndrome: the DEPACS study. Psychol Med. 2021 Apr;51(6):964-974. doi: 10.1017/S003329171900388X. Epub 2020 Jan 7.
Kim JW, Kang HJ, Bae KY, Kim SW, Shin IS, Yoon JS, Hong YJ, Ahn Y, Jeong MH, Kim JM. Social support deficit and depression treatment outcomes in patients with acute coronary syndrome: Findings from the EsDEPACS study. Int J Psychiatry Med. 2019 Jan;54(1):39-52. doi: 10.1177/0091217418791439. Epub 2018 Aug 4.
Kim JM, Stewart R, Lee YS, Lee HJ, Kim MC, Kim JW, Kang HJ, Bae KY, Kim SW, Shin IS, Hong YJ, Kim JH, Ahn Y, Jeong MH, Yoon JS. Effect of Escitalopram vs Placebo Treatment for Depression on Long-term Cardiac Outcomes in Patients With Acute Coronary Syndrome: A Randomized Clinical Trial. JAMA. 2018 Jul 24;320(4):350-358. doi: 10.1001/jama.2018.9422.
Kim JM, Stewart R, Kang HJ, Bae KY, Kim SW, Shin IS, Hong YJ, Ahn Y, Jeong MH, Yoon JS. BDNF methylation and depressive disorder in acute coronary syndrome: The K-DEPACS and EsDEPACS studies. Psychoneuroendocrinology. 2015 Dec;62:159-65. doi: 10.1016/j.psyneuen.2015.08.013. Epub 2015 Aug 17.
Kim JM, Stewart R, Bae KY, Kang HJ, Kim SW, Shin IS, Hong YJ, Ahn Y, Jeong MH, Yoon JS. Correlates and Escitalopram Treatment Effects on Sleep Disturbance in Patients with Acute Coronary Syndrome: K-DEPACS and EsDEPACS. Sleep. 2015 Jul 1;38(7):1105-11. doi: 10.5665/sleep.4822.
Kim JM, Stewart R, Bae KY, Kang HJ, Kim SW, Shin IS, Hong YJ, Ahn Y, Jeong MH, Yoon JS. Effects of depression co-morbidity and treatment on quality of life in patients with acute coronary syndrome: the Korean depression in ACS (K-DEPACS) and the escitalopram for depression in ACS (EsDEPACS) study. Psychol Med. 2015 Jun;45(8):1641-52. doi: 10.1017/S003329171400275X. Epub 2014 Nov 21.
Kim JM, Bae KY, Stewart R, Jung BO, Kang HJ, Kim SW, Shin IS, Hong YJ, Kim JH, Shin HY, Kang G, Ahn Y, Kim JK, Jeong MH, Yoon JS. Escitalopram treatment for depressive disorder following acute coronary syndrome: a 24-week double-blind, placebo-controlled trial. J Clin Psychiatry. 2015 Jan;76(1):62-8. doi: 10.4088/JCP.14m09281.
Other Identifiers
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LIIS-11592A
Identifier Type: -
Identifier Source: org_study_id
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