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Exercise and Pharmacotherapy in Patients With Major Depression: One-Year Follow-Up of the SMILE Study

Hoffman, Benson M. PhD; Babyak, Michael A. PhD; Craighead, W. Edward PhD; Sherwood, Andrew PhD; Murali Doraiswamy, P. MD; Coons, Michael J. MA; Blumenthal, James A. PhD

doi: 10.1097/PSY.0b013e31820433a5
Original Articles

Objective: To examine a 1-year follow-up of a 4-month, controlled clinical trial of exercise and antidepressant medication in patients with major depressive disorder (MDD).

Methods: In the original study, 202 sedentary adults with MDD were randomized to: a) supervised exercise; b) home-based exercise; c) sertraline; or d) placebo pill. We examined two outcomes measured at 1-year follow-up (i.e., 16 months post randomization): 1) continuous Hamilton Depression Rating Scale score; and 2) MDD status (depressed; partial remission; full remission) in 172 available participants (85% of the original cohort). Regression analyses were performed to examine the effects of treatment group assignment, as well as follow-up antidepressant medication use and self-reported exercise (Godin Leisure-Time Exercise Questionnaire), on the two outcomes.

Results: In the original study, patients receiving exercise achieved similar benefits compared with those receiving sertraline. At the time of the 1-year follow-up, rates of MDD remission increased from 46% at post treatment to 66% for participants available for follow-up. Neither initial treatment group assignment nor antidepressant medication use during the follow-up period were significant predictors of MDD remission at 1 year. However, regular exercise during the follow-up period predicted both Hamilton Depression Rating Scale scores and MDD diagnosis at 1 year. This relationship was curvilinear, with the association concentrated between 0 minute and 180 minutes of weekly exercise.

Conclusion: The effects of aerobic exercise on MDD remission seem to be similar to sertraline after 4 months of treatment; exercise during the follow-up period seems to extend the short-term benefits of exercise and may augment the benefits of antidepressant use.

Trial Registration: Identifier: NCT00331305.

MDD = major depressive disorder; HAM-D = Hamilton Depression Rating Scale; SCID = Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Axis I Disorders; PSSS = Perceived Social Support Scale.


From the Department of Psychiatry and Behavioral Sciences (B.M.H., M.A.B., A.S., M.D., M.J.C., J.A.B.), Duke University Medical Center, Durham, North Carolina; and the Department of Psychology (W.E.C.), Emory University, Atlanta, Georgia.

Address correspondence and reprint requests to Benson M. Hoffman, PhD, Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Box 3119, Durham, NC 27710. E-mail:

Received for publication May 26, 2010; revision received October 6, 2010.

This study was supported, in part, by Grant MH 49679 (J.A.B.) from the National Institutes of Health and Grant M01-RR-30 from the General Clinical Research Center Program, National Center for Research Resources, National Institutes of Health (Principal Investigator: James A. Blumenthal). Medication and matched placebo pills were provided by a grant from Pfizer Pharmaceuticals, Inc.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal's Web site

Dr. Craighead receives support from the National Institutes of Health for his research, owns stock in NovaDel Pharma, and receives book royalties from John Wiley & Sons. He is an officer of Hugarheill enf, an Icelandic nonprofit company dedicated to the prevention of depression. Dr. Murali Doraiswamy has received research grants (through Duke) and honoraria from several pharmaceutical companies, and he owns stock in EnergyInside. The remaining authors did not disclose any potential conflicts of interest.

Copyright © 2011 by American Psychosomatic Society
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