Exercise to Treat Depression in Individuals With Coronary Heart Disease

NCT00302068

Last updated date
Study Location
Duke University Medical Center
Durham, North Carolina, 27710, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Depression, Heart Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Depression, Heart DiseasesExercise to Treat Depression in Individuals With Coronary Heart Disease
NCT00302068
  1. Durham, North Carolina
ALL GENDERS
35 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Exercise to Treat Depression in Individuals With Coronary Heart Disease
Official Title  ICMJE Understanding the Prognostic Benefits of Exercise and Anti-depressant Therapy (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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Heart Diseases
Intervention  ICMJE
  • Behavioral: Supervised Aerobic Exercise
    Supervised aerobic exercise, three times per week, for 16 weeks.
  • Drug: Sertraline
    Sertraline (Zoloft), daily, for 16 weeks.
  • Drug: Placebo Pill.
    Placebo pill, daily, for 16 weeks.
Study Arms  ICMJE
  • Experimental: 1
    Supervised aerobic exercise, three times per week for 16 weeks.
    Intervention: Behavioral: Supervised Aerobic Exercise
  • Active Comparator: 2
    Sertraline (Zoloft), for 16 weeks.
    Intervention: Drug: Sertraline
  • Placebo Comparator: 3
    Placebo control, for 16 weeks.
    Intervention: Drug: Placebo Pill.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2012)
101
Original Enrollment  ICMJE
 (submitted: March 9, 2006)
200
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00302068
Other Study ID Numbers  ICMJE Pro00011980
R01HL080664-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:James A. Blumenthal, PhDDuke University
PRS Account Duke University
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP