Exercise to Treat Depression in Individuals With Coronary Heart Disease

NCT00302068 | Completed Phase 3 Results DMC

• 2 other identifiers: Pro00011980R01HL080664-01A1
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Heart Diseases

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale

  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.

  Measured at 16 weeks

Secondary Outcomes (6)

• Heart Rate Variability (HRV)

  Baseline, 16 weeks

• Percent Change in Flow Mediated Dilation (FMD)

  Baseline, 16 weeks

• C-reactive Protein (CRP)

  Baseline, 16 weeks

• Platelet Factor 4

  Baseline, 16 weeks

• Baroreflex Sensitivity (BRS)

  Baseline, 16 weeks

Study Arms (3)

1

EXPERIMENTAL

Supervised aerobic exercise, three times per week for 16 weeks.

Behavioral: Supervised Aerobic Exercise

2

ACTIVE COMPARATOR

Sertraline (Zoloft), for 16 weeks.

Drug: Sertraline

3

PLACEBO COMPARATOR

Placebo control, for 16 weeks.

Drug: Placebo Pill.

Interventions

Supervised Aerobic Exercise BEHAVIORAL

Supervised aerobic exercise, three times per week, for 16 weeks.

1

Sertraline DRUG

Sertraline (Zoloft), daily, for 16 weeks.

2

Placebo Pill. DRUG

Placebo pill, daily, for 16 weeks.

3

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Pfizer: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (7)

• 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. doi: 10.1097/00006842-200009000-00006.

  PMID: 11020092 BACKGROUND

• 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. doi: 10.1001/archinte.159.19.2349.

  PMID: 10547175 BACKGROUND

• 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. doi: 10.1001/jama.293.13.1626.

  PMID: 15811982 BACKGROUND

• 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. doi: 10.1016/j.amepre.2004.09.003.

  PMID: 15626549 BACKGROUND

• 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. doi: 10.1016/s0197-2456(02)00226-x.

  PMID: 12392873 BACKGROUND

• 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. doi: 10.1097/01.psy.0000126207.43307.c0.

  PMID: 15184688 BACKGROUND

• Blumenthal JA, Sherwood A, Babyak MA, Watkins LL, Smith PJ, Hoffman BM, O'Hayer CV, Mabe S, Johnson J, Doraiswamy PM, Jiang W, Schocken DD, Hinderliter AL. Exercise and pharmacological treatment of depressive symptoms in patients with coronary heart disease: results from the UPBEAT (Understanding the Prognostic Benefits of Exercise and Antidepressant Therapy) study. J Am Coll Cardiol. 2012 Sep 18;60(12):1053-63. doi: 10.1016/j.jacc.2012.04.040. Epub 2012 Aug 1.

  PMID: 22858387 BACKGROUND

MeSH Terms

Conditions

Depression; Heart Diseases; Motor Activity

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Relatively small sample size. Participants had to be willing to accept the condition to which they were randomly assigned, and patients who were not interested in exercise or taking an antidepressant were unlikely to have volunteered.

Results Point of Contact

• Title: Dr. James Blumenthal
• Organization: DukeUMC

blume003@mc.duke.edu

919-684-3969

Study Officials

• James A. Blumenthal, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2006
• First Posted: March 13, 2006
• Study Start: July 1, 2006
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 29, 2015
• Results First Posted: January 24, 2013

Record last verified: 2015-05

Locations

US (1)