Exercise Training Versus Drug Therapy for Treating Depression in Older Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00331305
First received: May 26, 2006
Last updated: August 28, 2013
Last verified: December 2007
  Purpose

This study will evaluate the effectiveness of both center-based and home-based exercise versus the antidepressant drug sertraline in treating depression in middle-aged and older adults.


Condition Intervention Phase
Depression
Behavioral: Supervised Exercise
Behavioral: Home-Based Exercise
Drug: Sertraline (Zoloft)
Drug: Placebo Pill
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Exercise Training and Depression in Older Adults II

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Measured at Week 16 and Months 6 and 12 post-treatment: Post-treatment recovery from MDD
  • Post-treatment depression scores on the Hamilton Depression Rating Scale

Secondary Outcome Measures:
  • Measured at Week 16 and Months 6 and 12 post-treatment: Quality of life (MOS SF 36)
  • Anxiety (State Trait Anxiety Inventory)
  • Cognitive Functioning (selected subtests from the Wechsler Memory Scale-R and WAIS-III; Digit Vigilance; Trail Making Test; Finger Tapping Test; Controlled Oral Word Association)
  • Cardiovascular biomarkers, including flow mediated dilation, heart rate variability, and baroreflex sensitivity

Enrollment: 457
Study Start Date: August 1999
Study Completion Date: May 2007
Detailed Description:

The combination of an aging population and the increased prevalence of chronic diseases among the elderly presents a major public health concern. Depression acts as both a cause and a consequence of disability, and with major depressive disorder (MDD) affecting up to 25% of women and 12% of men during their lifetimes, effective treatments for people of all ages must be made available. Although antidepressant medications are available as treatments for MDD, they sometimes either do not adequately relieve depressive symptoms, or do relieve depressive symptoms, but cause undesirable side effects. These side effects may become more common or more problematic as people age. Alternative approaches to treating depression, therefore, are necessary. Research suggests that exercise positively affects the levels of certain mood-enhancing neurotransmitters in the brain. This study will evaluate the effectiveness of both center-based and home-based exercise versus the antidepressant drug sertraline in treating depression in middle-aged and older adults.

Participants in this double-blind study will be randomly assigned to one of the following four treatments for 16 weeks: supervised aerobic exercise; home-based aerobic exercise; drug therapy; or placebo. All participants assigned to an exercise condition will report to the study site for a baseline exercise stress test. Participants assigned to supervised aerobic exercise will attend study visits 3 times per week for an exercise session. Each session will entail 10 minutes of warm-up exercises, followed by 30 to 35 minutes of continuous walking, biking, or jogging, and 10 to 15 minutes of cool-down exercises. Participants assigned to home-based aerobic exercise will attend one introductory session with an exercise physiologist, who will prescribe an exercise regimen and provide instruction on how to self-monitor pulse rate. They will also receive written information about their exercise plan, tips for maintaining progress and relapse prevention, and daily activity logs. The exercise prescription will be adjusted on a bi-weekly basis. Participants will be expected to exercise 3 times per week on their own, and will perform 10 minutes of warm-up exercises, followed by 30 to 35 minutes of continuous walking, biking, or jogging, and 10 to 15 minutes of cool-down exercises. In addition, they will mail in daily activity logs weekly for the first 6 weeks and biweekly for the remaining 10 weeks. Brief telephone contacts will be made to monitor progress, answer questions, and provide individualized feedback. Additionally, the exercise physiologist will conduct home visits at Weeks 4 and 8. Participants assigned to receive sertraline or placebo will receive their medication in pill-form at baseline and Weeks 2, 4, 8, 12, and 16 study visits. All participants will receive several phone calls to assess treatment response and suicide risk. These calls will take place weekly for the first 4 weeks and biweekly for the remainder of the study. Follow-up visits will occur at Months 6 and 12 post-treatment, and will include participating in psychological interviews and filling out questionnaires.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of major depressive disorder (MDD)
  • Score of greater than 11 on the Beck Depression Inventory (BDI)

Exclusion Criteria:

  • Primary psychiatric diagnosis other than major depressive disorder (e.g., bipolar disorder)
  • Any of the following DSM-IV diagnoses: dementia or delirium; obsessive compulsive disorder (OCD); schizophrenia, schizoaffective, or other psychotic disorder; psychotic features, including any delusions or hallucinations during the current depressive episode; current alcohol or other substance abuse disorder; acute risk for suicide (e.g., score of greater than 2 on the suicide item on the HAM-D) or acute risk for homicide
  • May require treatment with additional psychotherapeutic agents (other than chloral hydrate for sleep) during the course of the study
  • Significant medical conditions that may cause an increased risk for a significant adverse experience during the course of the trial (e.g., unstable angina, myocardial infarction within 3 months of study entry, etc.)
  • Unable to be randomly assigned to the study drug due to a risk for adverse cardiac events, such as prolonged QT interval, use of other medications that would be counterindicated for use with sertraline, or other conditions that may make study participation unsafe
  • Unable to be randomly assigned to an exercise condition due to medical conditions such as musculoskeletal problems or abnormal cardiac response to exercise (e.g., exercise-induced ventricular tachycardia, abnormal blood pressure response, etc.)
  • Currently receiving antidepressant medication or actively engaged in psychotherapy
  • Currently exercising regularly
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331305

Locations
United States, North Carolina
Duke University Medical Center, Department of Psychiatry and Behavioral Sciences
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: James A. Blumenthal, PhD Duke University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00331305     History of Changes
Other Study ID Numbers: Pro00010275, R01MH049679, DSIR GT-GS
Study First Received: May 26, 2006
Last Updated: August 28, 2013
Health Authority: United States: Federal Government

Keywords provided by Duke University:
Exercise

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014