Exercise Training Versus Drug Therapy for Treating Depression in Older Adults

NCT00331305 | Completed Phase 3 DMC

• 3 other identifiers: Pro00010275R01MH049679DSIR GT-GS
• Study Type: interventional
• Target: 457
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

Exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Interventions

Supervised Exercise BEHAVIORAL

Home-Based Exercise BEHAVIORAL

Sertraline (Zoloft) DRUG

Placebo Pill DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Duke University Medical Center, Department of Psychiatry and Behavioral Sciences

Durham, North Carolina, 27710, United States

Location

Related Publications (5)

• 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

• Barbour KA, Blumenthal JA. Exercise training and depression in older adults. Neurobiol Aging. 2005 Dec;26 Suppl 1:119-23. doi: 10.1016/j.neurobiolaging.2005.09.007. Epub 2005 Oct 11.

  PMID: 16223547 BACKGROUND

• Sherwood A, Blumenthal JA, Smith PJ, Watkins LL, Hoffman BM, Hinderliter AL. Effects of Exercise and Sertraline on Measures of Coronary Heart Disease Risk in Patients With Major Depression: Results From the SMILE-II Randomized Clinical Trial. Psychosom Med. 2016 Jun;78(5):602-9. doi: 10.1097/PSY.0000000000000301.

  PMID: 26867076 DERIVED

• Hoffman BM, Babyak MA, Craighead WE, Sherwood A, Doraiswamy PM, Coons MJ, Blumenthal JA. Exercise and pharmacotherapy in patients with major depression: one-year follow-up of the SMILE study. Psychosom Med. 2011 Feb-Mar;73(2):127-33. doi: 10.1097/PSY.0b013e31820433a5. Epub 2010 Dec 10.

  PMID: 21148807 DERIVED

• Blumenthal JA, Babyak MA, Doraiswamy PM, Watkins L, Hoffman BM, Barbour KA, Herman S, Craighead WE, Brosse AL, Waugh R, Hinderliter A, Sherwood A. Exercise and pharmacotherapy in the treatment of major depressive disorder. Psychosom Med. 2007 Sep-Oct;69(7):587-96. doi: 10.1097/PSY.0b013e318148c19a. Epub 2007 Sep 10.

  PMID: 17846259 DERIVED

MeSH Terms

Conditions

Depression; Motor Activity

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• James A. Blumenthal, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2006
• First Posted: May 29, 2006
• Study Start: August 1, 1999
• Study Completion: May 1, 2007
• Last Updated: August 29, 2013

Record last verified: 2007-12

Locations

US (1)