Journal
BIOLOGICAL PSYCHIATRY
Volume 63, Issue 5, Pages 524-529Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.biopsych.2007.04.043
Keywords
adolescents; clozapine; double-blind randomized clinical trial; olanzapine; schizophrenia
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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.
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