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The oral dose-effect relationship for fluvoxamine: a fixed-dose comparison against placebo in depressed outpatients.
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.
Afiliación
  • Walczak DD; CNS Division, Solvay Pharmaceuticals, Inc., Marietta, Georgia 30062, USA.
Ann Clin Psychiatry ; 8(3): 139-51, 1996 Sep.
Article en En | MEDLINE | ID: mdl-8899132
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.
Asunto(s)
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fluvoxamina / Inhibidores Selectivos de la Recaptación de Serotonina / Trastorno Depresivo Tipo de estudio: Clinical_trials / Observational_studies Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Ann Clin Psychiatry Asunto de la revista: PSIQUIATRIA Año: 1996 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fluvoxamina / Inhibidores Selectivos de la Recaptación de Serotonina / Trastorno Depresivo Tipo de estudio: Clinical_trials / Observational_studies Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Ann Clin Psychiatry Asunto de la revista: PSIQUIATRIA Año: 1996 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos