Fluvoxamine prevents recurrence of depression: results of a long-term, double-blind, placebo-controlled study.

ABSTRACT

This double-blind placebo-controlled study specifically tested the efficacy of fluvoxamine, at a dose of 100 mg a day, in reducing the risk of new episodes of depression. Out of 436 patients treated openly with fluvoxamine 283 patients fulfilled stringent criteria to define responders at 6 weeks. A total of 204 patients maintained their remission throughout a continuation treatment period of 18 weeks and then entered the prophylactic study. They were randomly assigned to receive either fluvoxamine 100 mg a day or placebo for 1 year. There were significantly fewer recurrences of new episodes of depression in the fluvoxamine group compared with the placebo group (p < 0.001). The significant advantage for fluvoxamine was also seen in the Kaplan-Meier analysis of time to recurrence (p < 0.001). The clear-cut efficacy of 100 mg of fluvoxamine and the good tolerability and side-effect profile demonstrated in this study support the view that fluvoxamine is particularly suitable for maintenance or prophylactic treatment.