Status:
COMPLETED
Exercise to Treat Depression in Individuals With Coronary Heart Disease
Lead Sponsor:
Duke University
Collaborating Sponsors:
Pfizer
Conditions:
Depression
Heart Diseases
Eligibility:
All Genders
35+ years
Phase:
PHASE3
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 eff...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00302068
Start Date
July 1 2006
End Date
December 1 2011
Last Update
June 29 2015
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710