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Sponsored by: |
Duke University |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00574847 |
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 |
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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) |
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 |
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1: Experimental
Escitalopram treatment
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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.
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2: Placebo Comparator
Placebo
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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.
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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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shelby N Ladd, B.A. | 919-668-3647 | shelby.ladd@duke.edu |
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. |
Principal Investigator: | Wei Jiang, M.D. | Duke University |
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 |
Health Authority: | United States: Institutional Review Board |
ischemic heart disease mental stress-induced myocardial ischemia escitalopram |
Heart Diseases Myocardial Ischemia Stress, Psychological Vascular Diseases Stress |
Ischemia Dexetimide Citalopram Serotonin |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents Serotonin Uptake Inhibitors |
Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Pathologic Processes Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |