Responses of Myocardial Ischemia to Escitalopram Treatment - Full Text View

Sponsor:	Duke University
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00574847

Purpose

Depression is commonly seen in patients with cardiovascular disorders. In recent studies it has been shown that mild to moderate depression symptoms were associated with increased likelihood of mental stress-induced myocardial ischemia (MSIMI), which is a risk factor of poor cardiac outcome. In this project, the investigators aim to assess the treatment of mental stress-induced myocardial ischemia in ischemic heart disease patients with mild to moderate depressive symptoms. This study is a six-week double-blind placebo controlled study to examine the effects of escitalopram on mental stress-induced myocardial ischemia. This study will look to show that patients with ischemic heart disease who are treated with escitalopram will exhibit a significant improvement of MSIMI at the end of week 6 compared to patients receiving placebo.

Condition	Intervention	Phase
Myocardial Ischemia	Drug: Escitalopram Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	Responses of Myocardial Ischemia to Escitalopram Treatment (REMIT Trial)

Resource links provided by NLM:

MedlinePlus related topics: Depression Heart Diseases Stress

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Patients with IHD treated with escitalopram will exhibit a significant improvement of MSIMI at the end of week 6 compared to patients receiving placebo [ Time Frame: 5 year study - 6 weeks of treatment for each patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Treatment of escitalopram will significantly reduce cardiovascular reactivity during mental stress testing as compared to placebo. Treatment of escitalopram will significantly reduce depression symptoms as compared to placebo [ Time Frame: 5 year study - 6 weeks of treatment for each patient ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Escitalopram treatment	Drug: Escitalopram Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
2: Placebo Comparator Placebo	Drug: Placebo Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.

Detailed Description:

The goals of this project are to investigate the response of mental stress-induced myocardial ischemia (MSIMI) to escitalopram, an SSRI; to determine whether MSIMI will be reduced by the treatment, and whether the modification of MSIMI is related to improvement of depression symptoms, and/or the reduction of platelet aggregation, and/or the reduction of cardiovascular reactivity. This is a randomized study using escitalopram versus placebo for stable ischemic heart disease patients with MSIMI. This study will also explore the role of platelet activity in occurrence with MSIMI and other characteristics of MSIMI, such as systolic and diastolic function of the left ventricle during mental stress testing as compared to exercise testing.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 21 or greater
Stable ischemic heart disease
BDI score greater than 4

Exclusion Criteria:

Recent myocardial infarction, coronary artery bypass graft surgery, or other revascularization procedures (less than 3 months ago)
LVEF (left ventricular ejection fraction) < 15% measured by echocardiography, RNV, or cardiac catheterization
Life threatening arrhythmia or arrhythmia interrupting the interpretation of ischemia
Unable to withdraw from anti-anginal medications during ischemic assessment phase
Unable to perform exercise testing
Pregnancy
Current or previous history of bipolar disorder, cyclothymia, schizophrenia, schizoaffective or schizophreniform disorder, or other psychotic disorders
Active suicidal ideation
Current substance abuse or history of substance abuse in the previous 6 months
Significant cardiac, pulmonary, metabolic, renal, hepatic disease, or malignancy, interfering with patient's participation in this study
Seizure (history and/or present) with/without treatment
Currently taking antidepressants that cannot be discontinued

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574847

Contacts

Contact: Shelby N Ladd, B.A.

919-668-3647

shelby.ladd@duke.edu

Locations

United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Shelby N Ladd, B.A. 919-668-3647 shelby.ladd@duke.edu
Contact: Jennifer Wilson 919-681-4367 jennifer.wilson@duke.edu
Principal Investigator: Wei Jiang, M.D.

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:

Wei Jiang, M.D.

Duke University

More Information

No publications provided

Responsible Party:	Duke University Medical Center ( Wei Jiang, MD )
Study ID Numbers:	8640-07-8R1ER, R01 HL085704-01
Study First Received:	December 12, 2007
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00574847 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

ischemic heart disease
mental stress-induced myocardial ischemia
escitalopram

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Myocardial Ischemia
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases

Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Heart Diseases
Vascular Diseases
Ischemia
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009