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Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome

Primary Purpose

Depressive Disorder, Coronary Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Escitalopram
Placebo
Sponsored by
Chonnam National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Depression, Myocardial infarction, Angina, unstable

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chonnam National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Escitalopram

Placebo pill

Arm Description

Outcomes

Primary Outcome Measures

Score on the Hamilton Depression Rating Scale-17 item

Secondary Outcome Measures

Scores on the Beck Depression Inventory
Changes in electrocardiographic, echocardiographic, and angiographic variables
Scores on the Montgomery Asberg Depression Rating Scale
Scores on the Clinical Global Impression scale
Scores on the World Health Organization Quality of Life scale
Scores on the Social and Occupational Functioning Assessment Scale
Scores on the World Health Organization Disability Assessment Schedule

Full Information

First Posted
January 5, 2007
Last Updated
June 11, 2013
Sponsor
Chonnam National University Hospital
Collaborators
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00419471
Brief Title
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

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital
Collaborators
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Coronary Disease
Keywords
Depression, Myocardial infarction, Angina, unstable

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Escitalopram
Arm Type
Experimental
Arm Title
Placebo pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro, Cipralex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo medication will be provided as matched 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day.
Primary Outcome Measure Information:
Title
Score on the Hamilton Depression Rating Scale-17 item
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Scores on the Beck Depression Inventory
Time Frame
24 weeks
Title
Changes in electrocardiographic, echocardiographic, and angiographic variables
Time Frame
24 weeks
Title
Scores on the Montgomery Asberg Depression Rating Scale
Time Frame
24 weeks
Title
Scores on the Clinical Global Impression scale
Time Frame
24 weeks
Title
Scores on the World Health Organization Quality of Life scale
Time Frame
24 weeks
Title
Scores on the Social and Occupational Functioning Assessment Scale
Time Frame
24 weeks
Title
Scores on the World Health Organization Disability Assessment Schedule
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Sang Yoon, MD & PhD
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae-Min Kim, MD & PhD
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
35459929
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.
Results Reference
derived
PubMed Identifier
32836109
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.
Results Reference
derived
PubMed Identifier
31907104
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.
Results Reference
derived
PubMed Identifier
30079814
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.
Results Reference
derived
PubMed Identifier
30043065
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. Erratum In: JAMA. 2018 Nov 27;320(20):2154.
Results Reference
derived
PubMed Identifier
26313133
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.
Results Reference
derived
PubMed Identifier
25581916
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.
Results Reference
derived
PubMed Identifier
25412614
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.
Results Reference
derived
PubMed Identifier
25375836
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.
Results Reference
derived

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Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome

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