The oral dose-effect relationship for fluvoxamine: a fixed-dose comparison against placebo in depressed outpatients.
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.
CNS Division, Solvay Pharmaceuticals, Inc., Marietta, Georgia 30062, USA.
D D
DD
Walczak
J T
JT
Apter
J A
JA
Halikas
R L
RL
Borison
J S
JS
Carman
G L
GL
Post
R
R
Patrick
J B
JB
Cohn
L A
LA
Cunningham
B
B
Rittberg
S H
SH
Preskorn
J S
JS
Kang
C S
CS
Wilcox
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D003866:Depressive Disorder / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D016666:Fluvoxamine / Q000008:administration & dosage*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010352:Patient Dropouts; D011569:Psychiatric Status Rating Scales; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage*; D012720:Severity of Illness Index; D013997:Time Factors
D016666:Fluvoxamine; D017367:Selective Serotonin Reuptake Inhibitors