Treatment of Dysthymia With Sertraline: A Double-Blind, Placebo-Controlled Trial in Dysthymic Patients Without Major Depression

Background: The selective serotonin reuptakeinhibitor sertraline has been shown to be efficacious and welltolerated for the treatment of major depressive disorder.Relatively few trials, however, have examined the role ofpharmacotherapy in dysthymia without concurrent major depression.The current investigation focuses on the use of sertraline forthe treatment of dysthymia.

Method: In this 12-week, multicenter,double-blind study, 310 patients with a DSM-III-R diagnosis ofdysthymic disorder without concurrent major depression wererandomly assigned to receive either sertraline (N = 158) orplacebo (N = 152). Sertraline was initiated at a dose of 50 mgdaily, with titration permitted to a maximum of 200 mg daily. Theprimary evaluation criteria were the Structured Interview Guidefor the Hamilton Depression Rating Scale, Seasonal AffectiveDisorder Version (SIGH-SAD), the Montgomery-Asberg DepressionRating Scale (MADRS), and the Clinical GlobalImpressions-Severity of Illness (CGI-S) and -Improvement (CGI-I)scales.

Results: Mean percentage reductions for theintent-to-treat population in SIGH-SAD scores were 44.6% for thesertraline-treated group and 33.2% for the placebo-treated group(p = .03); MADRS scores, 43.6% and 33.0% (p = .02); and CGI-Sscores, 32.8% and 22.8% (p = .02). A significantly greaterproportion of the sertraline-treated group was classified asresponders (defined for HAM-D and MADRS scores as a 50% scorereduction and for CGI-I as a score of 1 or 2 by the final visit)and remitters (SIGH-SAD score <= 8) relative to theplacebo-treated group by the final visit. In addition,sertraline-treated patients experienced greater improvements inall 9 domains of the Battelle Quality of Life Questionnaire thanplacebo-treated patients did, with a significant differenceobserved in favor of sertraline in 8 of the 9 domains. The lifesatisfaction and social interaction quality of life domainsshowed significantly greater response in sertraline responderscompared with placebo SIGH-SAD responders. Sertraline was welltolerated. Thirteen percent of the sertraline-treated groupversus 8% of the placebo-treated group withdrew from therapyowing to adverse events (p = .14).

Conclusion: Sertraline is efficacious and welltolerated in the short-term treatment of dysthymia withoutconcurrent major depression.