Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome

NCT00419471 | Completed Phase 4 DMC

• 1 other identifier: LIIS-11592A
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Depressive Disorder; Coronary Disease

Keywords

Depression; Myocardial infarction; Angina, unstable

Outcome Measures

Primary Outcomes (1)

• Score on the Hamilton Depression Rating Scale-17 item

  24 weeks

Secondary Outcomes (7)

• Scores on the Beck Depression Inventory

  24 weeks

• Changes in electrocardiographic, echocardiographic, and angiographic variables

  24 weeks

• Scores on the Montgomery Asberg Depression Rating Scale

  24 weeks

• Scores on the Clinical Global Impression scale

  24 weeks

• Scores on the World Health Organization Quality of Life scale

  24 weeks

Study Arms (2)

Escitalopram

EXPERIMENTAL

Drug: Escitalopram

Placebo pill

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Escitalopram DRUG

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.

Also known as: Lexapro, Cipralex

Escitalopram

Placebo DRUG

Placebo medication will be provided as matched 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day.

Placebo pill

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonnam National University Hospital: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

Chonnam National University Hospital

Gwangju, 501-757, South Korea

Location

Related Publications (9)

• 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.

  PMID: 35459929 DERIVED

• 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.

  PMID: 32836109 DERIVED

• 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.

  PMID: 31907104 DERIVED

• 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.

  PMID: 30079814 DERIVED

• 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. doi: 10.1001/jama.2018.15103.

  PMID: 30043065 DERIVED

• 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.

  PMID: 26313133 DERIVED

• 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.

  PMID: 25581916 DERIVED

• 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.

  PMID: 25412614 DERIVED

• 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.

  PMID: 25375836 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Coronary Disease; Depression; Myocardial Infarction; Angina, Unstable

Interventions

Escitalopram; Dexetimide

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavioral Symptoms; Behavior; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jin-Sang Yoon, MD & PhD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

• Jae-Min Kim, MD & PhD

  Chonnam National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 5, 2007
• First Posted: January 8, 2007
• Study Start: May 1, 2007
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 13, 2013

Record last verified: 2013-06

Locations

KR (1)