A Controlled Study of Olanzapine in Children With Autism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Children's Psychiatric Rating Scale
研究概览
简要总结
This is a 12-week study which investigates the use of olanzapine to decrease disruptive behaviors sometimes associated with Autism in children, aged 3 to 12 years old. The first six weeks of the study are double-blind and placebo controlled, meaning that patients receive either placebo or olanzapine, and that neither the researchers nor the patients know whether or not they are receiving placebo or olanzapine. In the second six weeks all of the patients receive olanzapine. The purpose in using placebo is that it is otherwise impossible to know how effective the drug is or whether or not the drug causes side effects. Patients treated with placebo can have improvement and can have side effects. In the study patients receive a psychiatric evaluation, physical examination, laboratory tests, and study medication (olanzapine or placebo), free of charge.
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
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, Aged between 3 and 12 years.
- •Autistic disorder - DSM-IV criteria.
- •A score of at least moderately impaired on the CGI-Severity item.
- •Clinical judgment that medication treatment for autism is indicated.
排除标准
- •Rett's disorder, childhood disintegrative disorder, Asperger's disorder, and PDD, NOS.
- •Psychotic disorder (DSM-IV) (including schizophreniform disorder and schizophrenia).
- •Major depressive disorder (DSM-IV).
- •Bipolar disorder (DSM-IV).
- •History of psychoactive drug in the previous 2 weeks prior to phase
- •A history of treatment with olanzapine for a cumulative period of greater than 2 weeks prior to entering phase
- •Systemic diseases such as cardiac, renal, thyroid diseases, uncontrolled seizure disorder (seizure disorder that is not controlled by anti-epileptic medication - a child who is seizure free for a period of 6 months on a stable dose of antiepileptic drug would be considered controlled), or diabetes mellitus.
- •Children with a known medical cause for autistic disorder.
- •Abnormal fasting blood glucose or history of diabetes.
- •Baseline body mass index (BMI) greater than the 90th percentile for age and gender (CDC growth charts, Kuczmarski et al, 2000) (because of risk of weight gain).
- •Baseline QTc >450 msec. Note: Historically, patients we evaluate do not have QTc values >
- •Dyskinesias at baseline (per the criteria of Schooler and Kane, 1982).
研究组 & 干预措施
1
Treatment with olanzapine
干预措施: olanzapine (Zyprexa) (Drug)
2
Matching placebo treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Children's Psychiatric Rating Scale
时间窗: Weekly
次要结局
- Aberant Behavior Checklist(Weekly)
- Abnormal Involuntary Movement Scale(Weekly)
- Clinical Global Impressions(Weekly)
- Olanzapine Untoward Effects Checklist(Weekly)
- Treatment Emergent Symptoms Scale(Weekly)
- Neurological Rating Scale(Weekly)