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

J Am Geriatr Soc. 2004 Jan;52(1):86-92. doi: 10.1111/j.1532-5415.2004.52015.x.

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Analysis of Variance
  • Antidepressive Agents / therapeutic use*
  • Comorbidity
  • Depressive Disorder / drug therapy*
  • Depressive Disorder / psychology
  • Double-Blind Method
  • Female
  • Health Status Indicators
  • Humans
  • Male
  • Middle Aged
  • Quality of Life
  • Sertraline / therapeutic use*
  • Treatment Outcome

Substances

  • Antidepressive Agents
  • Sertraline