A Long-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 86
- 主要终点
- Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score
研究概览
简要总结
The objective of this study is to investigate the safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient meets Autistic disorder diagnostic criteria defined in DSM-IV-TR.
- •The patient has completed the 031-11-002 study (the patient has visited the hospital during week8)
- •Inpatient or outpatient status
排除标准
- •The patient is currently diagnosed with another disorder on the autism spectrum in DSM-IV-TR, including Asperger's, Rett's Disorder, PDD-NOS, Childhood Disintegrative Disorder, or Fragile-X Syndrome.
- •Patients who fall under a contraindication listed in the ABILIFY package insert
研究组 & 干预措施
Aripiprazole
administered orally once daily
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score
时间窗: Baseline, the final administration
The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition.
次要结局
未报告次要终点