TY - JOUR
T1 - Clozapine and "High-Dose" Olanzapine in Refractory Early-Onset Schizophrenia
T2 - A 12-Week Randomized and Double-Blind Comparison
AU - Kumra, Sanjiv
AU - Kranzler, Harvey
AU - Gerbino-Rosen, Ginny
AU - Kester, Hana M.
AU - DeThomas, Courtney
AU - Kafantaris, Vivian
AU - Correll, Christoph U.
AU - Kane, John M.
PY - 2008/3/1
Y1 - 2008/3/1
N2 - 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.
AB - 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.
KW - Adolescents
KW - clozapine
KW - double-blind randomized clinical trial
KW - olanzapine
KW - schizophrenia
UR - http://www.scopus.com/inward/record.url?scp=38949096818&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=38949096818&partnerID=8YFLogxK
U2 - 10.1016/j.biopsych.2007.04.043
DO - 10.1016/j.biopsych.2007.04.043
M3 - Article
C2 - 17651705
AN - SCOPUS:38949096818
SN - 0006-3223
VL - 63
SP - 524
EP - 529
JO - Biological Psychiatry
JF - Biological Psychiatry
IS - 5
ER -