Exercise to Treat Depression in Individuals With Coronary Heart Disease
Condition: Depression; Heart Diseases
MeSH terms: Heart Diseases; Depression; Depressive Disorder
Intervention: Supervised Aerobic Exercise; Sertraline; Placebo Pill.
Intervention description: Supervised aerobic exercise, three times per week, for 16 weeks.; Sertraline (Zoloft), daily, for 16 weeks.; Placebo pill, daily, for 16 weeks.
Intervention MeSH terms: Sertraline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Exercise

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.
    

Eligibility 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