Single-blind comparison of the efficacy of fluvoxamine versus placebo in patients with depressive syndrome

This study reports the results obtained in 41 subjects with depressive syndrome treated with a new nontricyclic antidepressant drug, fluvoxamine. The study was conducted in two groups of patients, divided at random. One group was treated with fluvoxamine 100 mg/day for the first three days and 150 mg/day thereafter, and the other group was treated with placebo. The duration of treatment was four weeks. Utilizing the Hamilton Rating Scale for Depression (HRSD), the efficacy of flovoxamine appeared greater in comparison with placebo based on the global score. After seven days of treatment fluvoxamine also induced a significant reduction in the partial scores connected with anxiety and depression, a reduction that became greater during the course of treatment. On the contrary, in the first seven days placebo induced only a significant variation in the global score and in the partial score relative to anxiety. The reduction disappeared over the course of treatment. Much less significant was the reduction of the partial score relative to the depression. Tolerability of fluvoxamine was good overall, with nausea and vomiting as the prevalent side effects, which appeared only at the beginning of treatment. The frequency and seriousness of the anticholinergic side effects were extremely modest.