Efficacy, safety, and tolerability of sertraline in patients with late-life depression and comorbid medical illness.
OBJECTIVE
To report on the efficacy, safety, and tolerability of sertraline in the treatment of elderly depres-sed patients with and without comorbid medical illness.


METHODS
Multicenter.


METHODS
Randomized, double-blind, placebo-controlled study.


METHODS
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.


METHODS
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.


CONCLUSIONS
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.
Sheikh
Javaid I
JI
Stanford University School of Medicine, Stanford, California Veterans Affairs Palo Alto Health Care System, Menlo Park, California 94305, USA. sheikh@stanford.edu
Cassidy
Erin L
EL
Doraiswamy
P Murali
PM
Salomon
Ronald M
RM
Hornig
Mady
M
Holland
Peter J
PJ
Mandel
Francine S
FS
Clary
Cathryn M
CM
Burt
Tal
T
D000368:Aged; D000704:Analysis of Variance; D000928:Antidepressive Agents / Q000627:therapeutic use*; D015897:Comorbidity; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D020280:Sertraline / Q000627:therapeutic use*; D016896:Treatment Outcome
D000928:Antidepressive Agents; D020280:Sertraline