Department of Psychiatry,
University of Texas Southwestern Medical Center at
Dallas, USA.
BACKGROUND: This report presents
results from the acute treatment phase of a clinical
trial designed to confirm efficacy of a fixed dose
of 20 mg of Fluoxetine in children and adolescents
with major depressive disorder (MDD). METHOD: After
a 3-week screening period, 122 children and 97 adolescents
with MDD ( ) were randomly assigned to placebo or
Fluoxetine. After a 1-week placebo lead-in, Fluoxetine-treated
patients received Fluoxetine 10 mg/day for 1 week,
then Fluoxetine 20 mg/day for 8 weeks. RESULTS: Fluoxetine
was associated with greater mean improvement in Children's
Depression Rating Scale-Revised (CDRS-R) score than
placebo after 1 week ( <.05) and throughout the
study period. Significantly more Fluoxetine-treated
patients (41%) met the prospectively defined criteria
for remission than did placebo-treated patients (20%)
( <.01). More Fluoxetine- (65%) than placebo-treated
(53%) patients met the prospectively defined response
criterion of > or =30% decrease in CDRS-R score,
but this difference was not significant ( =.093).
Significantly more Fluoxetine-than placebo-treated
patients completed acute treatment ( =.001). There
were no significant differences between treatment
groups in discontinuations due to adverse events (
=.408). CONCLUSION: Fluoxetine 20 mg daily appears
to be well tolerated and effective for acute treatment
of MDD in child and adolescent outpatients. Fluoxetine
is the only antidepressant that has demonstrated efficacy
in two placebo-controlled, randomized clinical trials
of pediatric depression.
