Treatment of Dysthymia With Sertraline: A Double-Blind, Placebo-Controlled Trial in Dysthymic Patients Without Major Depression
J Clin Psychiatry 2000;61(11):821-827
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: The selective serotonin reuptake
inhibitor sertraline has been shown to be efficacious and well
tolerated for the treatment of major depressive disorder.
Relatively few trials, however, have examined the role of
pharmacotherapy in dysthymia without concurrent major depression.
The current investigation focuses on the use of sertraline for
the treatment of dysthymia.
Method: In this 12-week, multicenter,
double-blind study, 310 patients with a DSM-III-R diagnosis of
dysthymic disorder without concurrent major depression were
randomly assigned to receive either sertraline (N = 158) or
placebo (N = 152). Sertraline was initiated at a dose of 50 mg
daily, with titration permitted to a maximum of 200 mg daily. The
primary evaluation criteria were the Structured Interview Guide
for the Hamilton Depression Rating Scale, Seasonal Affective
Disorder Version (SIGH-SAD), the Montgomery-Asberg Depression
Rating Scale (MADRS), and the Clinical Global
Impressions-Severity of Illness (CGI-S) and -Improvement (CGI-I)
Results: Mean percentage reductions for the
intent-to-treat population in SIGH-SAD scores were 44.6% for the
sertraline-treated group and 33.2% for the placebo-treated group
(p = .03); MADRS scores, 43.6% and 33.0% (p = .02); and CGI-S
scores, 32.8% and 22.8% (p = .02). A significantly greater
proportion of the sertraline-treated group was classified as
responders (defined for HAM-D and MADRS scores as a 50% score
reduction and for CGI-I as a score of 1 or 2 by the final visit)
and remitters (SIGH-SAD score <= 8) relative to the
placebo-treated group by the final visit. In addition,
sertraline-treated patients experienced greater improvements in
all 9 domains of the Battelle Quality of Life Questionnaire than
placebo-treated patients did, with a significant difference
observed in favor of sertraline in 8 of the 9 domains. The life
satisfaction and social interaction quality of life domains
showed significantly greater response in sertraline responders
compared with placebo SIGH-SAD responders. Sertraline was well
tolerated. Thirteen percent of the sertraline-treated group
versus 8% of the placebo-treated group withdrew from therapy
owing to adverse events (p = .14).
Conclusion: Sertraline is efficacious and well
tolerated in the short-term treatment of dysthymia without
concurrent major depression.