Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Exercise to Treat Depression in Individuals With Coronary Heart Disease (UPBEAT)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00302068
First received: March 9, 2006
Last updated: December 14, 2012
Last verified: November 2012
Results First Received: November 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depression
Heart Diseases
Interventions: Behavioral: Supervised Aerobic Exercise
Drug: Sertraline
Drug: Placebo Pill.

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment began in June 2006 and ended in September 2010. Participants were recruited from physician referrals, community-based screenings, and mass media advertisements.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Supervised Aerobic Exercise Supervised aerobic exercise: Patients in the exercise condition attended 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients were assigned training ranges equivalent to 70 to 85 percent of maximal heart rate reserve. Each aerobic session consisted of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
Sertraline (Zoloft) Sertraline (Zoloft): Participants in the 2 pill conditions were given the selective serotonin reuptake inhibitor sertraline or a matching placebo. Medications were taken once daily; the dosage depended on the clinical response, but usually, each patient started at 50 mg (1 pill) of drug or placebo and progressed up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects. The treating psychiatrist was blinded to pill condition and used supportive measures to help manage medication side effects. Outcome assessors were unaware of patients' treatment assignments, and only the research pharmacist was aware of which patients were assigned to sertraline or to placebo. The primary endpoint was the HAM-D score at the end of 4 months. Secondary endpoints included remission of depression, defined as no Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of MDD (33) and a HAM-D score 8 (34), and cardiovascular biomarkers.
Placebo Control Placebo control: Participants in the 2 pill conditions were given the selective serotonin reuptake inhibitor sertraline or a matching placebo. Medications were taken once daily; the dosage depended on the clinical response, but usually, each patient started at 50 mg (1 pill) of drug or placebo and progressed up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects. The treating psychiatrist was blinded to pill condition and used supportive measures to help manage medication side effects. Outcome assessors were unaware of patients' treatment assignments, and only the research pharmacist was aware of which patients were assigned to sertraline or to placebo. The primary endpoint was the HAM-D score at the end of 4 months. Secondary endpoints included remission of depression, defined as no Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of MDD (33) and a HAM-D score 8 (34), and cardiovascular biomarkers

Participant Flow:   Overall Study
    Supervised Aerobic Exercise     Sertraline (Zoloft)     Placebo Control  
STARTED     37     40     24  
COMPLETED     36     36     23  
NOT COMPLETED     1     4     1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Supervised Aerobic Exercise Supervised aerobic exercise: Patients in the exercise condition attended 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients were assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session consisted of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
Sertraline (Zoloft) Sertraline (Zoloft)- Participants in the 2 pill conditions were given the selective serotonin reuptake inhibitor sertraline or a matching placebo. Medications were taken once daily, the dosage depended on the clinical response, but usually, each patient started at 50 mg (1 pill) of drug or placebo and progressed up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects. The treating psychiatrist was blinded to pill condition and used supportive measures to help manage medication side effects. Outcome assessors were unaware of patients treatment assignments, and only the research pharmacist was aware of which patients were assigned to sertraline or to placebo. The primary endpoint was the HAM-D score at the end of 4 months. Secondary endpoints included remission of depression, defined as no Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of MDD (33) and a HAM-D score 8 (34), and cardiovascular biomarkers.
Placebo Control Placebo control- Participants in the 2 pill conditions were given the selective serotonin reuptake inhibitor sertraline or a matching placebo. Medications were taken once daily; the dosage depended on the clinical response, but usually, each patient started at 50 mg (1 pill) of drug or placebo and progressed up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects. The treating psychiatrist was blinded to pill condition and used supportive measures to help manage medication side effects. Outcome assessors were unaware of patients treatment assignments, and only the research pharmacist was aware of which patients were assigned to sertraline or to placebo. The primary endpoint was the HAM-D score at the end of 4 months. Secondary endpoints included remission of depression, defined as no Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of MDD (33) and a HAM-D score 8 (34), and cardiovascular biomarkers
Total Total of all reporting groups

Baseline Measures
    Supervised Aerobic Exercise     Sertraline (Zoloft)     Placebo Control     Total  
Number of Participants  
[units: participants]
  37     40     24     101  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     22     24     14     60  
>=65 years     15     16     10     41  
Age  
[units: years]
Mean ± Standard Deviation
  64.7  ± 11.0     63.4  ± 10.2     63.5  ± 11.4     63.9  ± 11  
Gender  
[units: participants]
       
Female     13     15     4     32  
Male     24     25     20     69  
Region of Enrollment  
[units: participants]
       
United States     37     40     24     101  



  Outcome Measures

1.  Primary:   Hamilton Depression Rating Scale   [ Time Frame: Measured at 16 weeks ]

2.  Secondary:   Heart Rate Variability   [ Time Frame: 16 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Flow Mediated Dilation   [ Time Frame: 16 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Blood Markers of Inflammation   [ Time Frame: 16 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Platelet Aggregation   [ Time Frame: 16 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. James Blumenthal
Organization: DukeUMC
phone: 919-684-3969
e-mail: blume003@mc.duke.edu


Publications:


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00302068     History of Changes
Other Study ID Numbers: Pro00011980, R01 HL080664-01A1
Study First Received: March 9, 2006
Results First Received: November 1, 2012
Last Updated: December 14, 2012
Health Authority: United States: Federal Government