An Open-Label Study of Aripiprazole in Children and Adolescents With Autistic Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The Irritability subscale of the Aberrant Behavior Checklist (ABC)
研究概览
简要总结
The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment for individuals with Asperger's Disorder and Pervasive Developmental Disorder. This is an open-label investigation of aripiprazole in the management of the maladaptive behaviors of autistic disorder. We hypothesize that aripiprazole will be effective for reducing aggression and repetitive behavior.
详细描述
Pervasive developmental disorders (PDD) are characterized be severe impairments in social interaction and communication in addition to restricted patterns of interests and activities. Research suggests that a dysregulation of the dopamine and serotonin systems contributes to these interfering behaviors in individuals with PDD. After benefits of typical neuroleptics were reported in subjects with PDD's, research shifted to the atypical antipsychotics, which have been shown to be better tolerated and effective in this population. However, the atypical antipsychotics have also been associated with adverse effects. Thus there remains a need for a novel pharmacotherapy that would be safe and effective for children and adolescents with PDD's including Asperger's disorder and PDD Not Otherwise Specified (PDD NOS). We hypothesize that aripiprazole will be effective for reducing aggression and repetitive behavior. We also hypothesize that aripiprazole will be well tolerated, with low risk for extrapyramidal symptoms, hyperprolactinemia, weight gain, or corrected QT interval (QTc) prolongation. In addition, this open-label study will serve to stimulate more definitive, controlled research.
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
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mental age of 18 months
- •Diagnosis of Asperger's Disorder or Pervasive Developmental Disorder
- •Good health overall
- •Free of all psychotropic medication for 2 weeks
排除标准
- •Weight less than 15kg
- •Subjects who have received an adequate trial of aripiprazole
- •An active seizure disorder
- •A significant medical condition
- •History of neuroleptic malignant syndrome
- •Females with positive Beta human chorionic gonadotropin(HCG) pregnancy test
研究组 & 干预措施
Aripiprazole
Aripiprazole 5 mg per day for 2 weeks, then can be increased to 10mg per day if tolerated for 2 weeks, then can be increased to 15 mg per day for 4 weeks.
干预措施: aripiprazole (Drug)
结局指标
主要结局
The Irritability subscale of the Aberrant Behavior Checklist (ABC)
时间窗: Every 2 weeks
The Clinical Global Impression(CGI)Improvement Scale.
时间窗: Every 2 Weeks
次要结局
- The Vineland Maladaptive Behavior Subscale.(At baseline and endpoint)
- The Clinical Global Impression Severity Scale.(At baseline and endpoint)
- The Compulsion subscale of the Children's Yale-Brown Obsessive-Compulsive(CY-BOCS).(At baseline and endpoint)