Exercise to Treat Depression in Individuals With Coronary Heart Disease (UPBEAT)
|Depression Heart Diseases||Behavioral: Supervised Aerobic Exercise Drug: Sertraline Drug: Placebo Pill.||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Understanding the Prognostic Benefits of Exercise and Anti-depressant Therapy (UPBEAT)|
- Hamilton Depression Rating Scale [ Time Frame: Measured at 16 weeks ]The Hamilton Depression Rating Scale ranges from 0 to 52, with lower scores reflecting lower levels of depression and higher scores greater severity of depression.
- Heart Rate Variability (HRV) [ Time Frame: Baseline, 16 weeks ]HRV is the variation in the time interval between heart beats. ECG was recorded for 24 hours on a 3-channel digital compact ash Holter recorder. During the recording period, patients engaged in their normal patterns of activity. ECG data were downloaded and edited using the Pathfinder digital ambulatory ECG analyzer (DelMar Reynolds, lrvine, California) and HRV was estimated from the standard deviation of all normal R—R intervals (SDNN)
- Percent Change in Flow Mediated Dilation (FMD) [ Time Frame: Baseline, 16 weeks ]Endothelial function assessed by flow mediated dilation (FMD). Brachial artery FMD was assessed following overnight fasting. Longitudinal B-mode ultrasound images of the brachial artery, 4-6 cm proximal to the antecubital crease, were obtained using an Aeuson (Mountain View, California) Aspen ultrasoundplatformwith an 11MHZ linear array transducer. lmages were obtained after 10 min of supine relaxation and during reactive hyperemia, induced following in ation of a forearm pneumatic occlusion cuff to supra-systolic pressure (~200 mmHg) for 5 minutes. FMD was defined as the maximum percent change inarterial diameter relative to restingbaseline from 10-120 sec post-deflation of the occlusion cuff.
- C-reactive Protein (CRP) [ Time Frame: Baseline, 16 weeks ]
- Platelet Factor 4 [ Time Frame: Baseline, 16 weeks ]
- Baroreflex Sensitivity (BRS) [ Time Frame: Baseline, 16 weeks ]
- Interleuken 6 (IL-6) [ Time Frame: Baseline, 16 weeks ]
|Study Start Date:||July 2006|
|Study Completion Date:||December 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Supervised aerobic exercise, three times per week for 16 weeks.
Behavioral: Supervised Aerobic Exercise
Supervised aerobic exercise, three times per week, for 16 weeks.
Active Comparator: 2
Sertraline (Zoloft), for 16 weeks.
Sertraline (Zoloft), daily, for 16 weeks.
Placebo Comparator: 3
Placebo control, for 16 weeks.
Drug: Placebo Pill.
Placebo pill, daily, for 16 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302068
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||James A. Blumenthal, PhD||Duke University|