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临床试验/NCT00048828
NCT00048828已完成4 期

Treating Refractory Childhood Schizophrenia

Northwell Health3 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2001年10月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: Olanzapine (Drug)

2

Active Comparator

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

研究者

申办方类型
Other

研究点 (3)

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