Viewing Study NCT00302068



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Last Modification Date: 2024-10-26 @ 9:23 AM
Study NCT ID: NCT00302068
Status: COMPLETED
Last Update Posted: 2015-06-29
First Post: 2006-03-09

Brief Title: Exercise to Treat Depression in Individuals With Coronary Heart Disease
Sponsor: Duke University
Organization: Duke University

Study Overview

Official Title: Understanding the Prognostic Benefits of Exercise and Anti-depressant Therapy UPBEAT
Status: COMPLETED
Status Verified Date: 2015-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: UPBEAT
Brief Summary: Some individuals with coronary heart disease CHD suffer from depression and use antidepressant medications to reduce symptoms However preliminary research has shown that exercise may be a more effective way to treat depression in these individuals The purpose of this study is to evaluate the effects of exercise in reducing depression and improving heart function in individuals with CHD
Detailed Description: Coronary heart disease CHD is caused by a narrowing of the small blood vessels that supply blood and oxygen to the heart It is the leading cause of death in the United States Recent evidence has suggested that depression is a significant risk factor for individuals with CHD and may place additional strain on the heart Selective serotonin reuptake inhibitors SSRIs a type of antidepressant medication have been shown to be especially effective at reducing depression symptoms particularly for individuals with CHD However many people fail to benefit from medication alone or they experience negative side effects Therefore a need exists to identify alternative approaches for treating depression in individuals with CHD Preliminary research has shown that exercise may be an effective way to improve mood and treat depression More research however is needed to confirm the benefits of exercise in individuals with CHD The purpose of this study is to compare the effectiveness of a supervised exercise program antidepressant treatment and placebo in reducing depression and improving heart function in individuals with CHD

This 16-week study will enroll adults with a history of CHD and depression Participants will be randomly assigned to an aerobic exercise program antidepressant medication or placebo At study entry standardized psychological questionnaires will be completed and depression levels and exercise tolerance will be assessed Participants heart function will be evaluated through measures of flow-mediated vasodilatation inflammation platelet function baroreflex and heart rate variability Participants assigned to the exercise program will be required to engage in structured aerobic exercise Participants assigned to antidepressant medication will receive sertraline an SSRI or placebo The treating psychiatrist will be blinded to pill condition and will use supportive measures to help manage medication side effects Outcome assessors will be unaware of patients treatment assignments and only the research pharmacist will be aware of which patients are assigned to sertraline or to placebo

At Week 16 participants will return to the clinic for repeat assessments of baseline measures A follow-up evaluation will occur six months following the end of treatment and participants depression levels and clinical status will be assessed

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HL080664-01A1 NIH None httpsreporternihgovquickSearchR01HL080664-01A1