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

Javaid I. Sheikh, Erin L. Cassidy, P. Murali Doraiswamy, Ronald M. Salomon, Mady Hornig, Peter J. Holland, Francine S. Mandel, Cathryn M. Clary, Tal Burt

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OBJECTIVES: To report on the efficacy, safety, and tolerability of sertraline in the treatment of elderly depressed 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 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.

Original languageEnglish
Pages (from-to)86-92
Number of pages7
JournalJournal of the American Geriatrics Society
Issue number1
Publication statusPublished - 1 Jan 2004



  • Comorbid illness
  • Depression
  • Late-life

ASJC Scopus subject areas

  • Geriatrics and Gerontology

Cite this

Sheikh, J. I., Cassidy, E. L., Doraiswamy, P. M., Salomon, R. M., Hornig, M., Holland, P. J., Mandel, F. S., Clary, C. M., & Burt, T. (2004). Efficacy, Safety, and Tolerability of Sertraline in Patients with Late-Life Depression and Comorbid Medical Illness. Journal of the American Geriatrics Society, 52(1), 86-92. https://doi.org/10.1111/j.1532-5415.2004.52015.x