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A Randomized Trial

Kurt Kroenke, MD; Suzanne L. West, PhD; Ralph Swindle, PhD; Alicia Gilsenan, PhD; George J. Eckert, MAS; Rowena Dolor, MD; Paul Stang, PhD; Xiao-Hua Zhou, PhD; Ron Hays, PhD; Morris Weinberger, PhD

JAMA. 2001;286:2947-2955.

Context  Selective serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed class of antidepressant, yet it is not known whether one SSRI is more effective than another.

Objective  To compare the effectiveness of 3 SSRIs (paroxetine, fluoxetine, and sertraline) in depressed primary care patients.

Design  Open-label, randomized, intention-to-treat trial, with patient enrollment occurring in April-November 1999.

Setting  Thirty-seven clinics in 2 US primary care research networks.

Patients  A total of 573 depressed adult patients for whom their primary care physician thought that antidepressant therapy was warranted and who completed a baseline interview.

Interventions  Patients were randomly assigned to receive paroxetine (n = 189), fluoxetine (n = 193), or sertraline (n = 191) for 9 months. Primary care physicians were allowed to switch patients to a different SSRI or non-SSRI antidepressant if they did not adequately respond to or tolerate the initial SSRI.

Main Outcome Measures  The primary outcome measure was change in the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component Summary score (range, 0-100), compared across treatment groups at 1, 3, 6, and 9 months. Secondary outcomes included other depression and psychological measures, multiple measures of social and work functioning, and other domains of health-related quality of life, such as physical functioning, concentration and memory, vitality, bodily pain, sleep, and sexual functioning.

Results  Follow-up interviews were successfully completed in 94% of patients at 1 month, 87% at 3 months, 84% at 6 months, and 79% at 9 months. Responses to the 3 SSRIs were comparable on all measures and at all time points. The mean change in the SF-36 Mental Component Summary score at 9 months was + 15.8 in the paroxetine group, + 15.1 in the fluoxetine group, and + 17.4 in the sertraline group. The drugs were also associated with similar incidences of adverse effects and discontinuation rates.

Conclusions  The SSRI antidepressants paroxetine, fluoxetine, and sertraline were similar in effectiveness for depressive symptoms as well as multiple domains of health-related quality of life over the entire 9 months of this trial.

Author Affiliations: Regenstrief Institute for Health Care and Department of Medicine, Indiana University School of Medicine (Drs Kroenke, Zhou, and Weinberger and Mr Eckert), Eli Lilly & Co (Dr Swindle), and Center for Health Services Research, Roudebush Veterans Affairs Medical Center (Dr Weinberger), Indianapolis; Department of Psychology, Indiana University, Bloomington (Dr Swindle); Research Triangle Institute (Drs West and Gilsenan), and Duke University School of Medicine and Duke Primary Care Research Consortium, Durham, NC (Dr Dolor); Primary Care Network, and Galt Associates, Philadelphia, Pa (Dr Stang); RAND Health Program and Department of Medicine, School of Medicine, University of California, Los Angeles (Dr Hays); and University of North Carolina, Chapel Hill (Drs West and Stang).

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