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Efficacy, Safety, and Tolerability of Sertraline in Patients with Late‐Life Depression and Comorbid Medical Illness
Author(s) -
Sheikh Javaid I.,
Cassidy Erin L.,
Doraiswamy P. Murali,
Salomon Ronald M.,
Hornig Mady,
Holland Peter J.,
Mandel Francine S.,
Clary Cathryn M.,
Burt Tal
Publication year - 2004
Publication title -
journal of the american geriatrics society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.992
H-Index - 232
eISSN - 1532-5415
pISSN - 0002-8614
DOI - 10.1111/j.1532-5415.2004.52015.x
Subject(s) - sertraline , tolerability , medicine , hamd , comorbidity , placebo , depression (economics) , psychiatry , adverse effect , major depressive disorder , randomized controlled trial , clinical trial , antidepressant , alternative medicine , anxiety , mood , macroeconomics , pathology , economics
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.