Background
The present study evaluated the effectiveness and safety of clozapine versus “high-dose”
olanzapine in treatment-refractory adolescents with schizophrenia.
Methods
Children, ages 10–18 years, who met DSM-IV criteria for schizophrenia and who were
resistant or intolerant to at least two antipsychotic drugs were randomized to receive
12 weeks of double-blind flexibly dosed treatment with clozapine (n = 18) or “high-dose” olanzapine (up to 30 mg/day) (n = 21). The primary efficacy measure was response (improvement), defined as a decrease
of 30% or more in total Brief Psychiatric Rating Scale score from baseline and a Clinical
Global Impression Scale improvement rating of “1” (very much improved) or “2” (much
improved).
Results
Significantly more clozapine-treated adolescents met response criteria (66%) compared
with olanzapine-treated subjects (33%). Clozapine was superior to olanzapine in terms
of reduction of the psychosis cluster scores and negative symptoms from baseline to
end point. However, both treatments were associated with significant weight-gain and
related metabolic abnormalities.
Conclusions
This double-blind randomized comparison of two second-generation antipsychotic drugs
for treatment-refractory adolescents with schizophrenia supports clozapine as the
agent of choice. The development of interventions to limit weight gain and metabolic
side effects are needed to enhance the risk-benefit profile for both study treatments.
Key Words
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Article info
Publication history
Published online: July 28, 2007
Accepted:
April 24,
2007
Received in revised form:
March 27,
2007
Received:
December 1,
2006
Identification
Copyright
© 2008 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.