Efficacy, Safety, and Tolerability of Sertraline in Patients with Late-Life Depression and Comorbid Medical Illness

Authors

  • Javaid I. Sheikh MD,

    1. From the *Stanford University School of Medicine, Stanford, CaliforniaVeterans Affairs Palo Alto Health Care System, Menlo Park, CaliforniaDuke University School of Medicine, Durham, North Carolina§Vanderbilt University School of Medicine, Nashville, TennesseeColumbia University, New York, New YorkUniversity of South Florida, Tampa, Florida#Pfizer, Inc., Brooklyn, New York**Columbia University College of Physicians and Surgeons, New York.
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  • Erin L. Cassidy PhD,

    1. From the *Stanford University School of Medicine, Stanford, CaliforniaVeterans Affairs Palo Alto Health Care System, Menlo Park, CaliforniaDuke University School of Medicine, Durham, North Carolina§Vanderbilt University School of Medicine, Nashville, TennesseeColumbia University, New York, New YorkUniversity of South Florida, Tampa, Florida#Pfizer, Inc., Brooklyn, New York**Columbia University College of Physicians and Surgeons, New York.
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  • P. Murali Doraiswamy MD,

    1. From the *Stanford University School of Medicine, Stanford, CaliforniaVeterans Affairs Palo Alto Health Care System, Menlo Park, CaliforniaDuke University School of Medicine, Durham, North Carolina§Vanderbilt University School of Medicine, Nashville, TennesseeColumbia University, New York, New YorkUniversity of South Florida, Tampa, Florida#Pfizer, Inc., Brooklyn, New York**Columbia University College of Physicians and Surgeons, New York.
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  • Ronald M. Salomon MD,

    1. From the *Stanford University School of Medicine, Stanford, CaliforniaVeterans Affairs Palo Alto Health Care System, Menlo Park, CaliforniaDuke University School of Medicine, Durham, North Carolina§Vanderbilt University School of Medicine, Nashville, TennesseeColumbia University, New York, New YorkUniversity of South Florida, Tampa, Florida#Pfizer, Inc., Brooklyn, New York**Columbia University College of Physicians and Surgeons, New York.
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  • Mady Hornig MD,

    1. From the *Stanford University School of Medicine, Stanford, CaliforniaVeterans Affairs Palo Alto Health Care System, Menlo Park, CaliforniaDuke University School of Medicine, Durham, North Carolina§Vanderbilt University School of Medicine, Nashville, TennesseeColumbia University, New York, New YorkUniversity of South Florida, Tampa, Florida#Pfizer, Inc., Brooklyn, New York**Columbia University College of Physicians and Surgeons, New York.
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  • Peter J. Holland MD,

    1. From the *Stanford University School of Medicine, Stanford, CaliforniaVeterans Affairs Palo Alto Health Care System, Menlo Park, CaliforniaDuke University School of Medicine, Durham, North Carolina§Vanderbilt University School of Medicine, Nashville, TennesseeColumbia University, New York, New YorkUniversity of South Florida, Tampa, Florida#Pfizer, Inc., Brooklyn, New York**Columbia University College of Physicians and Surgeons, New York.
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  • Francine S. Mandel PhD,

    1. From the *Stanford University School of Medicine, Stanford, CaliforniaVeterans Affairs Palo Alto Health Care System, Menlo Park, CaliforniaDuke University School of Medicine, Durham, North Carolina§Vanderbilt University School of Medicine, Nashville, TennesseeColumbia University, New York, New YorkUniversity of South Florida, Tampa, Florida#Pfizer, Inc., Brooklyn, New York**Columbia University College of Physicians and Surgeons, New York.
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  • Cathryn M. Clary MD,

    1. From the *Stanford University School of Medicine, Stanford, CaliforniaVeterans Affairs Palo Alto Health Care System, Menlo Park, CaliforniaDuke University School of Medicine, Durham, North Carolina§Vanderbilt University School of Medicine, Nashville, TennesseeColumbia University, New York, New YorkUniversity of South Florida, Tampa, Florida#Pfizer, Inc., Brooklyn, New York**Columbia University College of Physicians and Surgeons, New York.
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  • Tal Burt MD

    1. From the *Stanford University School of Medicine, Stanford, CaliforniaVeterans Affairs Palo Alto Health Care System, Menlo Park, CaliforniaDuke University School of Medicine, Durham, North Carolina§Vanderbilt University School of Medicine, Nashville, TennesseeColumbia University, New York, New YorkUniversity of South Florida, Tampa, Florida#Pfizer, Inc., Brooklyn, New York**Columbia University College of Physicians and Surgeons, New York.
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  • Research support for this study was courtesy of Pfizer Pharmaceuticals. Authors Mandel, Clary, and Burt are all employees of Pfizer, Inc. Authors Sheikh, Doraiswamy, and Holland have served as consultants to Pfizer Pharmaceuticals.

Address correspondence to Javaid I. Sheikh, MD, Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, 401 Quarry Road, Stanford CA, 94305. E-mail: sheikh@stanford.edu

Abstract

Objectives: To report on the efficacy, safety, and tolerability of sertraline in the treatment of elderly depres-sed patients with and without comorbid medical illness.

Setting: Multicenter.

Design: Randomized, double-blind, placebo-controlled study.

Participants: A total of 752 patients aged 60 and older with diagnosis of major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis.

Measurements: Outcome measures included the 17-item Hamilton Depression Scale (HAMD); the Clinical Global Depression—Severity/Improvement (CGI-S/CGI-I); efficacy and safety/adverse event assessments; Quality of Life, Enjoyment, and Satisfaction Questionnaire; and the Medical Outcomes Study 36-Item Short-Form Health Status Survey.

Results: In the overall sample, sertraline was superior to placebo on all three primary outcome measures, HAMD, and overall clinical severity and change (CGI-S/CGI-I). Furthermore, therapeutic response to sertraline was comparable in those with or without medical comorbidity, and there were no treatment-by–comorbidity group interactions. Sertraline was also associated with a faster time to response than placebo in the comorbid group (P<.006). Sertraline-treated patients in the comorbid group had similar adverse events and discontinuations when compared to those in the noncomorbid group.

Conclusion: Sertraline was efficacious in reducing depressive symptomatology, regardless of the presence of comorbid medical illness. Sertraline was safe and well tolerated by patients with or without medical illness.

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