The oral dose-effect relationship for fluvoxamine: A fixed-dose comparison against placebo in depressed outpatients

Donna D. Walczak, Jeffrey T. Apter, James A. Halikas, Richard L. Borison, John S. Carman, Gary L. Post, Roger Patrick, Jay B. Cohn, Lynn A. Cunningham, Barry Rittberg, Sheldon H. Preskorn, Jasbir S. Kang, Charles S. Wilcox

Research output: Contribution to journalArticle

45 Scopus citations

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, aged 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 5O mg/day. Fluvoxamine maleate shows dose-related effectiveness in the acute treatment of major depressive disorder.

Original languageEnglish (US)
Pages (from-to)139-151
Number of pages13
JournalAnnals of Clinical Psychiatry
Volume8
Issue number3
DOIs
StatePublished - Sep 1996

Keywords

  • Depression
  • Dose-response
  • Efficacy
  • Fluvoxamine
  • Side effects

Fingerprint Dive into the research topics of 'The oral dose-effect relationship for fluvoxamine: A fixed-dose comparison against placebo in depressed outpatients'. Together they form a unique fingerprint.

  • Cite this

    Walczak, D. D., Apter, J. T., Halikas, J. A., Borison, R. L., Carman, J. S., Post, G. L., Patrick, R., Cohn, J. B., Cunningham, L. A., Rittberg, B., Preskorn, S. H., Kang, J. S., & Wilcox, C. S. (1996). The oral dose-effect relationship for fluvoxamine: A fixed-dose comparison against placebo in depressed outpatients. Annals of Clinical Psychiatry, 8(3), 139-151. https://doi.org/10.3109/10401239609147751