Treating Refractory Childhood Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 3
- 主要终点
- Psychotic, manic, aggressive, and depressive symptoms
研究概览
简要总结
This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and adolescents who have failed standard antipsychotic treatment for schizophrenia.
详细描述
Schizophrenia is a devastating illness regardless of the age at which it presents. When this disorder occurs in childhood or adolescence, the consequences in terms of functional impairment, loss of developmental opportunities, and family and societal burden are particularly dramatic.
Evidence supports the improved efficacy and/or side effect profile of atypical antipsychotic medication in adults. Thus, it is essential to examine whether the potential benefits of these agents can be extended to children, particularly children who have failed standard treatment.
Patients are randomly assigned to receive either clozapine or olanzapine daily for 12 weeks. Patients meet with the study team once a week to discuss progress and record side effects. Three parent meetings take place during the study. During these meetings, questions are discussed and support and education about schizophrenia are given to parents. Various scales to measure psychotic, manic, aggressive, and depressive symptoms are used to assess patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Neurological or medical disorders that would contraindicate treatment with clozapine or olanzapine
- •IQ less than 70
- •DSM-IV criteria for substance (other than caffeine or nicotine) related disorder
- •Failure of an adequate trial of olanzapine or clozapine
研究组 & 干预措施
1
干预措施: Olanzapine (Drug)
2
干预措施: Clozapine (Drug)
结局指标
主要结局
Psychotic, manic, aggressive, and depressive symptoms
时间窗: Measured over 12 weeks
次要结局
未报告次要终点
