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A Randomized, Placebo-Controlled Trial of Sertraline for Prophylactic Treatment of Highly Recurrent Major Depressive Disorder

OBJECTIVE: Previous antidepressant maintenance trials have used the same medication from acute through maintenance phases, confounding the interpretation of prophylactic effects. The purpose of this study was to determine whether sertraline prevents the recurrence of major depressive disorder among patients with recurrent depression who had been treated to remission with medications other than sertraline. METHOD: Patients who had experienced at least three documented episodes of major depressive disorder within the last 4 years and who were currently in full remission were eligible. The last episode must have been treated for at least 4 months with any antidepressant except sertraline. For the initial single-blind placebo lead-in phase, 371 patients were included; 288 were included in the analyses for the 18-month double-blind phase in which patients were randomly assigned to sertraline (50 or 100 mg) or placebo (two capsules per day). Recurrence was defined as a depressive episode that fulfilled DSM-IV criteria or the appearance of symptoms that required the administration of another antidepressant treatment. RESULTS: Sixty-one patients discontinued before the double-blind phase, including 33 who experienced a relapse. Out of the 288 who entered the double-blind prophylactic phase, 123 discontinued, including 65 for recurrences. Recurrences were significantly lower in the sertraline groups compared with placebo (sertraline, 50 mg: 16 [16.8%] of 95; sertraline, 100 mg: 16 [17.0%] of 94; placebo: 33 [33.3%] of 99). Patients treated with sertraline also had a significantly longer time until recurrence compared with placebo-treated patients. CONCLUSIONS: Among remitted patients with a history of multiple depressive episodes, sertraline at a dose of either 50 or 100 mg/day prevented recurrences significantly more than did placebo.

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