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Exercise to Treat Depression in Individuals With Coronary Heart Disease (UPBEAT)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00302068
First received: March 9, 2006
Last updated: December 14, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Depression
Heart Diseases
Behavioral: Supervised Aerobic Exercise
Drug: Sertraline
Drug: Placebo Pill.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Understanding the Prognostic Benefits of Exercise and Anti-depressant Therapy (UPBEAT)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: Measured at 16 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Heart Rate Variability [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Flow Mediated Dilation [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Blood Markers of Inflammation [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Platelet Aggregation [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: July 2006
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Drug: Sertraline
Sertraline (Zoloft), daily, for 16 weeks.
Placebo Comparator: 3
Placebo control, for 16 weeks.
Drug: Placebo Pill.
Placebo pill, daily, for 16 weeks.

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. 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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persistent depressive symptoms that may include the following: depressed mood; diminished interest or pleasure in activities; change in appetite; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue or loss of energy; feelings of worthlessness or inappropriate guilt; diminished ability to think or concentrate; or recurrent thoughts of death or suicidal ideations
  • Documented history of coronary heart disease (i.e., a prior heart attack, coronary artery bypass graft, or greater than 75% stenosis in at least one coronary artery)

Exclusion Criteria:

  • Experienced an acute heart attack or any revascularization procedure (i.e., CABG or percutaneous transluminal coronary angioplasty) within 60 days of study entry
  • Left ventricular ejection fraction <30% with labile ECG changes prior to testing
  • Currently using a pacemaker
  • Resting blood pressure greater than 160/100 mmHg
  • Left main disease >50%
  • Failure to meet our criteria for depression or achieve a score of ≥9 on the Beck Depression Inventory-II
  • Any other concurrent psychiatric intervention
  • Primary psychiatric diagnosis other than Major or Minor Depressive Episode
  • Primary diagnosis of the following psychiatric disorders: schizophrenia, bipolar disorder, schizoaffective disorder, other psychotic disorder, dementia, current delirium, current obsessive compulsive disorder
  • Experienced psychotic symptoms during the current depressive episode
  • Current abuse or dependence on alcohol or other drugs
  • Acute suicide risk
  • Patients who, during the course of the study, would likely require treatment with additional psychotherapeutic agents
  • Significant medical conditions that would make exercise or sertraline use medically inadvisable (e.g., unstable angina, heart attack within the 3 months prior to study entry, musculoskeletal problems, or congestive heart failure)
  • Abnormal thyroid-stimulating hormone (TSH) level and glucose level greater than or equal to 126 mg/dL
  • Patients who would not be able to be randomized to either the drug (e.g., adverse cardiac events such as prolonged QT interval, allergic responses) or exercise (e.g., musculoskeletal problems, abnormal cardiac response to exercise, such as exercise-induced VT, abnormal blood pressure response, etc.)
  • Currently using medications that would make exercise or sertraline use medically inadvisable (e.g., clonidine, dicumarol, warfarin, anticonvulsants, or MAO inhibitors)
  • Current uncontrolled medical condition that could be causing the depressive symptoms (e.g., thyroid dysfunction, anemia)
  • Pregnant, planning to get pregnant during the study period, or lactating
  • Herbal supplements with purported mood effects (e.g., St. John's wort, valerian, gingko)
  • Current use of antidepressant medication
  • Currently participating in psychotherapy
  • Currently participating in regular aerobic exercise
  • Documented failure to respond to sertraline therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302068

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Pfizer
Investigators
Principal Investigator: James A. Blumenthal, PhD Duke University
  More Information

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00302068     History of Changes
Other Study ID Numbers: Pro00011980, R01 HL080664-01A1
Study First Received: March 9, 2006
Results First Received: November 1, 2012
Last Updated: December 14, 2012
Health Authority: United States: Federal Government

Keywords provided by Duke University:
Exercise

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Depression
Depressive Disorder
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014