Efficacy, safety, and tolerability of sertraline in patients with late-life depression and comorbid medical illness.

Journal Article (Clinical Trial;Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • Sheikh, JI; Cassidy, EL; Doraiswamy, PM; Salomon, RM; Hornig, M; Holland, PJ; Mandel, FS; Clary, CM; Burt, T

Published Date

  • January 2004

Published In

Volume / Issue

  • 52 / 1

Start / End Page

  • 86 - 92

PubMed ID

  • 14687320

International Standard Serial Number (ISSN)

  • 0002-8614

Digital Object Identifier (DOI)

  • 10.1111/j.1532-5415.2004.52015.x


  • eng

Conference Location

  • United States