R. Bruce Lydiard, PhD, MD; Philip Perera, MD; Evan Batzar, MS; and Cathryn M. Clary, MD
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Background: New medications that enter the
marketplace have been tested almost exclusively in controlled
clinical trials conducted in specialty research settings. There
is some concern that these carefully selected patient samples may
not provide information generalizable to the "real
world" clinical population. The purpose of this
investigation was to compare results from a large, open-label
study of sertraline in the treatment of major depression in the
clinical practice setting with pooled results from 2 multicenter,
double-blind, placebo-controlled studies conducted in specialty
research settings.
Method: Clinical practice patients (N = 1482),
aged 21 to 65 years, from 228 psychiatric clinical practice sites
across the United States participated in the open-label treatment
study (Clinical Practice sample). Patients who met DSM-III-R
criteria for moderate-to-severe unipolar major depression (i.e.,
had pretreatment Hamilton Rating Scale for Depression [HAM-D]
scores >= 18) were treated for 8 weeks with sertraline in a
flexible dosing fashion (50-200 mg daily). Outcomes on the HAM-D
and Clinical Global Impressions-Improvement scale (CGI-I) were
compared with the pooled results from 2 previously published
placebo-controlled, multicenter treatment studies of sertraline
in outpatients with major depression (N = 280). The overall
response to sertraline in the Clinical Practice sample was
compared with the outcome from the research study patient sample
(Clinical Research sample). Additionally, comparison of outcomes
of patients with common depressive subtypes (double depression,
anxious depression, and melancholic ["endogenous"]
depression) were examined.
Results: The percentage of sertraline-treated
patients rated as responders on the CGI-I was significantly
higher in the Clinical Practice sample compared with the Clinical
Research sample (87% vs. 73%; p < .001). Sertraline was also
much better tolerated in the Clinical Practice sample than in the
Clinical Research sample as evidenced by significantly lower
overall reports of adverse events (9.4% vs. 13.2%; p < .05)
and lower patient dropout rates (17.5% vs. 34.3%; p < .01).
Among clinical practice patients, sertraline was found to be
equally effective in treating endogenous/melancholic and anxious
subtypes and only mildly less effective in achieving a response
in patients with double depression (chronic low-grade depression
with a superimposed major depression). A regression analysis
identified older age and double depression as being predictors of
a slower time to response. More than 70% of patients who reported
nonresponse to previous treatment with fluoxetine or a tricyclic
antidepressant responded to sertraline.
Conclusion: The effectiveness and tolerability
of sertraline treatment was found to be significantly better in
the Clinical Practice sample, suggesting that the results from
controlled studies in research settings may represent an
underestimate of the benefits of a drug. More effectiveness
research is needed to confirm and extend these findings.
Prim Care Companion J Clin Psychiatry 1999;1(5):154-162
https://doi.org/10.4088/PCC.v01n0504
© Copyright 1999 Physicians Postgraduate Press, Inc.