Exercise Training Versus Drug Therapy for Treating Depression in Older Adults

Depression Clinical Trial

Official title:

Exercise Training and Depression in Older Adults II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00331305
• Other study ID #: Pro00010275
• Secondary ID: R01MH049679DSIR
• Status: Completed
• Phase: Phase 3
• First received: May 26, 2006
• Last updated: August 28, 2013
• Start date: August 1999
• Est. completion date: May 2007

Study information

• Verified date: December 2007
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 457
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Supervised Exercise

• Home-Based Exercise

Drug:
• Sertraline (Zoloft)

• Placebo Pill

Locations

Country	Name	City	State
United States	Duke University Medical Center, Department of Psychiatry and Behavioral Sciences	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Barbour KA, Blumenthal JA. Exercise training and depression in older adults. Neurobiol Aging. 2005 Dec;26 Suppl 1:119-23. Epub 2005 Oct 11. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measured at Week 16 and Months 6 and 12 post-treatment: Post-treatment recovery from MDD
Primary	Post-treatment depression scores on the Hamilton Depression Rating Scale
Secondary	Measured at Week 16 and Months 6 and 12 post-treatment: Quality of life (MOS SF 36)
Secondary	Anxiety (State Trait Anxiety Inventory)
Secondary	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)
Secondary	Cardiovascular biomarkers, including flow mediated dilation, heart rate variability, and baroreflex sensitivity