Clinical trial NCT00419471: Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depressive Disorder
Coronary Disease
Keywords: Depression
Myocardial infarction
Angina, unstable
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2007-01-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Score on the Hamilton Depression Rating Scale-17 item
timeFrame: 24 weeks
Secondary outcomes:
measure: Scores on the Beck Depression Inventory
timeFrame: 24 weeks
measure: Changes in electrocardiographic, echocardiographic, and angiographic variables
timeFrame: 24 weeks
measure: Scores on the Montgomery Asberg Depression Rating Scale
timeFrame: 24 weeks
measure: Scores on the Clinical Global Impression scale
timeFrame: 24 weeks
measure: Scores on the World Health Organization Quality of Life scale
timeFrame: 24 weeks
measure: Scores on the Social and Occupational Functioning Assessment Scale
timeFrame: 24 weeks
measure: Scores on the World Health Organization Disability Assessment Schedule
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Jin-Sang Yoon, MD & PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Jae-Min Kim, MD & PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.