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  • Title: The oral dose-effect relationship for fluvoxamine: a fixed-dose comparison against placebo in depressed outpatients.
    Author: Walczak DD, Apter JT, Halikas JA, Borison RL, Carman JS, Post GL, Patrick R, Cohn JB, Cunningham LA, Rittberg B, Preskorn SH, Kang JS, Wilcox CS.
    Journal: Ann Clin Psychiatry; 1996 Sep; 8(3):139-51. PubMed ID: 8899132.
    Abstract:
    This 7- to 8-week, multicenter, randomized, double-blind, placebo-controlled study was performed to determine the dose-effect relationship and minimum effective dose for fluvoxamine maleate in a titrated fixed-dose study of major depressive disorder. Gradual titration over 2 weeks to fixed maintenance doses was employed to minimize dropout due to initial side effects. The study enrolled 600 outpatients, male and female, age 18-65, meeting DSM-III-R criteria for major depressive disorder. A 13-item subscore of the standard 21-Item Hamilton Depression Scale was used to minimize the possible contribution of known side effects from serotonin reuptake inhibitors to the overall HAM-D score. Secondary efficacy assessments included the HAM-D retardation factor, HAM-D depressed mood item, CGI-severity of illness item, and SCL depression factor. Fluvoxamine (50-150 mg/day) was therapeutically effective and well tolerated during 6 weeks of therapy. Based on the HAM-D depressed mood item, efficacy was dose dependent. The minimum effective dose was 50 mg/day. Fluvoxamine maleate shows dose-related effectiveness in the acute treatment of major depressive disorder.
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