A Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Controlled-Release Fluvoxamine in Patients With Obsessive-Compulsive Disorder
J Clin Psychiatry 2003;64(6):640-647
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Objective: The aim of this 12-week,
double-blind, flexible-dose, placebo-controlled, parallel-arm,
multicenter trial was to determine the safety and efficacy of
fluvoxamine in a controlled-release (CR) formulation in adult
outpatients with obsessive-compulsive disorder (OCD).
Method: 253 adult outpatients with DSM-IV OCD
were randomly assigned to receive 100 to 300 mg of fluvoxamine CR
(N = 127) or placebo (N = 126) once daily for 12 weeks.
Intent-to-treat analyses of efficacy assessments with the
Yale-Brown Obsessive Compulsive Scale (YBOCS), Clinical Global
Impressions-Severity of Illness scale (CGI-S), and Clinical
Global Impressions-Improvement scale (CGI-I) were conducted.
Results: Fluvoxamine CR was significantly (p
< .05) superior to placebo in decreasing YBOCS total score
beginning at week 2. This early response was sustained at all
subsequent visits. At endpoint, there was a mean decrease of 8.5
± 0.7 (31.7%) in the YBOCS total score compared with baseline in
the fluvoxamine CR treatment group versus a mean decrease of 5.6
± 0.7 (21.2%) in the placebo group (p = .001). Fluvoxamine CR
was also significantly superior to placebo in lowering the
severity of illness (CGI-S, p = .002) and in producing clinical
improvement (CGI-I, p < .01). At endpoint, significantly
greater percentages of the fluvoxamine CR treatment group were
responders (p = .002) and remitters (p = .019) compared with the
Conclusion: Over 12 weeks, fluvoxamine CR
treatment was associated with a statistically significant and
clinically relevant reduction in OCD severity and was found to be
safe and well tolerated. The early onset of therapeutic effect,
starting from week 2, was of particular interest.