FLUVOXAMINE MALEATE IN THE TREATMENT OF DEPRESSION - A SINGLE-CENTER,DOUBLE-BLIND, PLACEBO-CONTROLLED COMPARISON WITH IMIPRAMINE IN OUTPATIENTS

The efficacy and safety of fluvoxamine maleate, a selective serotonin reuptake inhibitor, was compared with placebo and imipramine in patien ts with major depressive disorder. Previous Literature has cited a dos e range of 100 to 300 mg/day of fluvoxamine maleate for the treatment of major depression; however, this study demonstrates that a dose rang e of 50 to 150 mg/day is as effective as imipramine (80-240 mg/day). A fter a 1- to 2-week, single-blind, placebo washout phase, 150 depresse d outpatients were randomized to double-blind treatment with fluvoxami ne maleate (50-150 mg/day), imipramine (80-240 mg/day), or placebo for 6 weeks. Fluvoxamine produced a significant therapeutic benefit over placebo (p less than or equal to 0.05) as assessed by the total score on the Hamilton Rating Scale for Depression; imipramine (80-240 mg/day ) produced similar results. The secondary outcome variables (i.e., Cli nical Global Impression severity of illness item and 56-Item Hopkins S ymptom Checklist depression factor) also showed significant difference s between fluvoxamine maleate and placebo during three of the four fin al weeks of the study. Both fluvoxamine maleate and imipramine appeare d to be safe and well tolerated by the majority of patients. As expect ed horn the pharmacology of these agents, the imipramine groups report ed more anticholinergic effects (dry mouth, dizziness, and urinary ret ention) and electrocardiographic effects, whereas the fluvoxamine grou p reported more nausea, somnolence, and abnormal ejaculation. The majo rity of these adverse events were mild to moderate and, with the excep tion of dry mouth (imipramine) and abnormal ejaculation (fluvoxamine), were transient. The data clearly demonstrate the antidepressant activ ity and tolerability of fluvoxamine maleate (50-150 mg/day) as compare d with placebo; it is also as effective as the tricyclic antidepressan t imipramine (80-240 mg/day) in patients with major depressive disorde r.