Efficacy of fluvoxamine in severe depression.

The therapeutic efficacy of fluvoxamine has been demonstrated in large numbers of patients participating in comparative double-blind placebo-controlled studies using imipramine as the active reference compound. Overall, patients treated with fluvoxamine for 4 to 6 weeks had significant amelioration of their depression compared with placebo-treated patients. More importantly, the response rate in patients with severe depression was greater than in patients with mild or moderate depression. However, several investigators have observed high placebo response rates, and in some studies there has been a similar response rate to imipramine and placebo treatment. While the high placebo response rate may have resulted from methodological problems, the issue does raise some questions that can only be resolved by further investigation.