DepressionPhase 3UPBEATNCT00302068
Exercise to Treat Depression in Individuals With Coronary Heart Disease
A Phase 3 study testing Supervised Aerobic Exercise and Sertraline in people with Depression and Heart Diseases, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Depression, Heart Diseases
- What is being tested?
- Supervised Aerobic Exercise and Sertraline
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Dec 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Understanding the Prognostic Benefits of Exercise and Anti-depressant Therapy (UPBEAT)
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.
Read the 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.
- Conditions
- Depression, Heart Diseases
- Being tested
- Supervised Aerobic Exercise, Sertraline, Placebo Pill.
- Keywords
- Exercise
- Medical subject headings
- Depression, Heart Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Aerobic ExerciseBehavioural
Supervised aerobic exercise, three times per week, for 16 weeks.
SertralineDrug
Sertraline (Zoloft), daily, for 16 weeks.
Placebo Pill.Drug
Placebo pill, daily, for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Supervised aerobic exercise, three times per week for 16 weeks. Receives: Behavioral: Supervised Aerobic Exercise |
| 2 | Active comparator | Sertraline (Zoloft), for 16 weeks. Receives: Drug: Sertraline |
| 3 | Placebo comparator | Placebo control, for 16 weeks. Receives: Drug: Placebo Pill. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at 16 weeks
Secondary outcomes (6)
Heart Rate Variability (HRV)
HRV is the variation in the time interval between heart beats. ECG was recorded for 24 hours on a 3-channel digital compact ash Holter recorder. During the recording period, patients engaged in their normal patterns of activity. ECG data were downloaded and edited using the Pathfinder digital ambulatory ECG analyzer (DelMar Reynolds, lrvine, California) and HRV was estimated from the standard deviation of all normal R-R intervals (SDNN)
Measured: Baseline, 16 weeks
Percent Change in Flow Mediated Dilation (FMD)
Endothelial function assessed by flow mediated dilation (FMD). Brachial artery FMD was assessed following overnight fasting. Longitudinal B-mode ultrasound images of the brachial artery, 4-6 cm proximal to the antecubital crease, were obtained using an Aeuson (Mountain View, California) Aspen ultrasoundplatformwith an 11MHZ linear array transducer. lmages were obtained after 10 min of supine relaxation and during reactive hyperemia, induced following in ation of a forearm pneumatic occlusion cuff to supra-systolic pressure (~200 mmHg) for 5 minutes. FMD was defined as the maximum percent change inarterial diameter relative to restingbaseline from 10-120 sec post-deflation of the occlusion cuff.
Measured: Baseline, 16 weeks
C-reactive Protein (CRP)
Measured: Baseline, 16 weeks
Platelet Factor 4
Measured: Baseline, 16 weeks
Baroreflex Sensitivity (BRS)
Measured: Baseline, 16 weeks
Interleuken 6 (IL-6)
Measured: Baseline, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2006 (estimated)
- Study startJul 2006
- Primary completionJul 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- James A. Blumenthal, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302068
- Sponsor's protocol ID
- Pro00011980
- Other IDs
- R01HL080664-01A1
- Acronym
- UPBEAT
- Status last verified
- May 2015
- First submitted
- 9 Mar 2006
- Last updated
- 29 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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. doi: 10.1097/00006842-200009000-00006.
PubMed 11020092Blumenthal 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.
PubMed 10547175Blumenthal 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.
PubMed 15811982Dunn 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.
PubMed 15626549Dunn 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.
PubMed 12392873Lett 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.
PubMed 15184688Blumenthal 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.
PubMed 22858387
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Prognostic Benefits of Exercise and Anti-depressant Therapy (UPBEAT)
- ClinicalTrials.gov ID
- NCT00302068
- Acronym / sponsor ID
- UPBEAT / Pro00011980
- Conditions
- Depression, Heart Diseases
- Keywords
- Exercise
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jul 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Mar 2006 (estimated)
- Results
- Posted 24 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Supervised Aerobic ExerciseSupervised aerobic exercise, three times per week for 16 weeks. |
| 2 | Active comparator | Drug: SertralineSertraline (Zoloft), for 16 weeks. |
| 3 | Placebo comparator | Drug: Placebo Pill.Placebo control, for 16 weeks. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (24 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Aerobic ExerciseSupervised aerobic exercise, three times per week, for 16 weeks. | Behavioural | 1 |
| SertralineSertraline (Zoloft), daily, for 16 weeks. | Drug | 2 |
| Placebo Pill.Placebo pill, daily, for 16 weeks. | Drug | 3 |
Primary outcome
Hamilton Depression Rating Scale
Time frame: Measured at 16 weeks
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.
6 secondary outcomes
Heart Rate Variability (HRV)
Time frame: Baseline, 16 weeks
Percent Change in Flow Mediated Dilation (FMD)
Time frame: Baseline, 16 weeks
C-reactive Protein (CRP)
Time frame: Baseline, 16 weeks
Platelet Factor 4
Time frame: Baseline, 16 weeks
Baroreflex Sensitivity (BRS)
Time frame: Baseline, 16 weeks
Interleuken 6 (IL-6)
Time frame: Baseline, 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11020092Babyak 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.
- Background: PubMed 10547175Blumenthal 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.
- Background: PubMed 15811982Blumenthal 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.
- Background: PubMed 15626549Dunn 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.
- Background: PubMed 12392873Dunn 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.
- Background: PubMed 15184688Lett 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.
- Background: PubMed 22858387Blumenthal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A. Blumenthal, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Supervised Aerobic Exercise and Sertraline in people with Depression and Heart Diseases, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (time frame: Measured at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00302068, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.