Clozapine and "high-dose" olanzapine in refractory early-onset schizophrenia: A 12-week randomized and double-blind comparison
Clozapine and "high-dose" olanzapine in refractory early-onset schizophrenia: A 12-week randomized and double-blind comparison
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DOI：
10.1016/j.biopsych.2007.04.043
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发表时间：
2008-03-01
影响因子：
10.6
通讯作者：
Kane, John M.
中科院分区：
文献类型：
--
作者：
Kumra, Sanjiv;Kranzler, Harvey;Kane, John M.
背景资料：本研究评价了氯氮平与“大剂量”奥氮平治疗难治性青少年精神分裂症的有效性和安全性。10-18岁儿童，符合DSM-IV精神分裂症诊断标准且对至少两种抗精神病药物耐药或不耐受的患者被随机分配接受12周的氯氮平（n = 18）或“高剂量”奥氮平（高达30 mg/天）（n = 21）。主要疗效指标是反应（改善），定义为减少30%或更多的总简明精神病评定量表评分从基线和临床总体印象量表改善评级为“1”（非常改善）或“2”（大大改善）。结果：显着更多的氯氮平治疗的青少年符合反应标准（66%）相比，奥氮平治疗的受试者（33%）。从基线到终点，氯氮平在减少精神病群集评分和阴性症状方面上级奥氮平。然而，这两种治疗都与显着的体重增加和相关的代谢abnormals.Conclusions：这两个第二代抗精神病药物治疗难治性青少年精神分裂症的双盲随机比较支持氯氮平作为代理的选择。需要开发限制体重增加和代谢副作用的干预措施，以增强两种研究治疗的风险-获益特征。
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.