Exercise to Treat Depression in Individuals With Coronary Heart Disease - Full Text View

Sponsors and Collaborators:	National Heart, Lung, and Blood Institute (NHLBI) Pfizer
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00302068

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 III

MedlinePlus related topics: Antidepressants Coronary Artery Disease Depression Exercise and Physical Fitness Heart Diseases

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Understanding the Prognostic Benefits of Exercise and Anti-Depressant Therapy (UPBEAT)

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Heart rate variability [ Time Frame: Measured at 16 weeks ] [ Designated as safety issue: Yes ]
Flow-mediated dilation [ Time Frame: Measured at 16 weeks ] [ Designated as safety issue: Yes ]
Platelet aggregation [ Time Frame: Measured at 16 weeks ] [ Designated as safety issue: Yes ]
Blood markers of inflammation [ Time Frame: Measured at 16 weeks ] [ Designated as safety issue: Yes ]
Hamilton Depression Rating Scale [ Time Frame: Measured at 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	July 2006
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Supervised aerobic exercise, three times per week for 16 weeks.	Behavioral: Supervised Aerobic Exercise Supervised aerobic exercise, three times per week, for 16 weeks.
2: Active Comparator Sertraline (Zoloft), for 16 weeks.	Drug: Sertraline Sertraline (Zoloft), daily, for 16 weeks.
3: Placebo Comparator Placebo control, for 16 weeks.	Drug: Placebo Pill. Placebo pill, daily, for 16 weeks.

Detailed Description:

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 CHD (i.e., a prior heart attack, coronary artery bypass graft [CABG], 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 [PTCA]) 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 OCD
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

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

Contacts

Contact: James A. Blumenthal, PhD	919-684-3828	blume003@mc.duke.edu
Contact: Andrew Sherwood, PhD	919-684-8835	sherw002@mc.duke.edu

Locations

United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: James A. Blumenthal, PhD 919-684-3828 blume003@duke.edu
Contact: Lephuong Ong, PhD 919-681-3006 Lephuong.Ong@duke.edu
Principal Investigator: Andrew Sherwood, PhD
Sub-Investigator: Robert Waugh, MD
Sub-Investigator: Michael Babyak, PhD
Sub-Investigator: Murali Doraiswamy, MD
Sub-Investigator: Lana Watkins, PhD

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Pfizer

Investigators

Principal Investigator:

James A. Blumenthal, PhD

Duke University

More Information

Publications:

Babyak M, Blumenthal JA, Herman S, Khatri P, Doraiswamy M, Moore K, Craighead WE, Baldewicz TT, Krishnan KR. Exercise treatment for major depression: maintenance of therapeutic benefit at 10 months. Psychosom Med. 2000 Sep-Oct;62(5):633-8.

Blumenthal JA, Babyak MA, Moore KA, Craighead WE, Herman S, Khatri P, Waugh R, Napolitano MA, Forman LM, Appelbaum M, Doraiswamy PM, Krishnan KR. Effects of exercise training on older patients with major depression. Arch Intern Med. 1999 Oct 25;159(19):2349-56.

Blumenthal JA, Sherwood A, Babyak MA, Watkins LL, Waugh R, Georgiades A, Bacon SL, Hayano J, Coleman RE, Hinderliter A. Effects of exercise and stress management training on markers of cardiovascular risk in patients with ischemic heart disease: a randomized controlled trial. JAMA. 2005 Apr 6;293(13):1626-34.

Dunn AL, Trivedi MH, Kampert JB, Clark CG, Chambliss HO. Exercise treatment for depression: efficacy and dose response. Am J Prev Med. 2005 Jan;28(1):1-8.

Dunn AL, Trivedi MH, Kampert JB, Clark CG, Chambliss HO. The DOSE study: a clinical trial to examine efficacy and dose response of exercise as treatment for depression. Control Clin Trials. 2002 Oct; 23(5): 584-603.

Lett HS, Blumenthal JA, Babyak MA, Sherwood A, Strauman T, Robins C, Newman MF. Depression as a risk factor for coronary artery disease: evidence, mechanisms, and treatment. Psychosom Med. 2004 May-Jun;66(3):305-15. Review.

Responsible Party:	Duke University Medical Center ( James A. Blumenthal, PhD )
Study ID Numbers:	373, R01 HL080664-01A1
Study First Received:	March 9, 2006
Last Updated:	February 10, 2009
ClinicalTrials.gov Identifier:	NCT00302068 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Exercise

Study placed in the following topic categories:

Neurotransmitter Agents
Heart Diseases
Depression
Myocardial Ischemia
Psychotropic Drugs
Vascular Diseases
Ischemia
Depressive Disorder
Serotonin Uptake Inhibitors

Serotonin
Behavioral Symptoms
Coronary Disease
Mental Disorders
Mood Disorders
Sertraline
Coronary Artery Disease
Antidepressive Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Physiological Effects of Drugs
Vascular Diseases
Psychotropic Drugs
Depressive Disorder
Serotonin Uptake Inhibitors

Pharmacologic Actions
Behavioral Symptoms
Coronary Disease
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Sertraline
Cardiovascular Diseases
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 07, 2009