Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Clinical Global Impression Improvement (CGI-AD)
研究概览
简要总结
Hypothesis: (1) Aripiprazole treatment will be superior to placebo in reducing aggression and irritability in autistic individuals as shown by reductions in the Aberrant Behavior Checklist-irritability subscale.
(2) Aripiprazole treatment will be superior to placebo in the acute treatment of global autism severity.
The purpose of this study is to examine the possible benefit of the medication Aripiprazole in autistic individuals.
详细描述
Aripiprazole is an atypical antipsychotic medication which is currently approved for the treatment of schizophrenia in adults. Multiple clinical trials in both children and adults have shown the effectiveness in the treatment of autism with medications like Aripiprazole. This study aims at assessing the effect of aripiprazole vs. placebo treatment on symptoms of irritability and aggression associated with autism, as well as the effect on the global severity of child and adolescent autistic disorder. Children or adolescent outpatients, with age ranges from 5-17, will be enrolled into an 8-week placebo controlled, double blind treatment study. During the 8 weeks, patients will be monitored by the treating psychiatrist. Study assessments will be administered at designated time points.
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
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets DSM-IV, ADI-R criteria for autistic disorder.
- •Age 5-17 years.
- •Outpatients
- •Parent or legal guardian willing to sign informed consent.
排除标准
- •Subject has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression).
- •Subject has caused visible harm to him/herself.
- •Subject has an active seizure disorder or epilepsy (seizures within the past year).
- •Subject has an unstable medical illness, including heart disease.
- •Subject has experienced brain injury.
- •Subject has a history of diabetes.
- •Subject reports significant improvement of autism symptoms and behaviors to current medication or other therapies.
- •Subject has a history of prior treatment with Aripiprazole of 5 mg/day or higher for 6 weeks.
- •Subject lives in a far away area and/or does not have regular access to transportation to the clinical facility.
- •Subject is a pregnant female or unwilling to use acceptable contraception if sexually active.
研究组 & 干预措施
Aripiprazole
Subjects in the experimental group will receive Aripiprazole
干预措施: Aripiprazole (Drug)
Placebo
Subjects in the control group will receive sugar pill
干预措施: Placebos (Drug)
结局指标
主要结局
Clinical Global Impression Improvement (CGI-AD)
时间窗: Administered weekly, initial and week 8 reported
Clinical Global Impression Improvement (CGI)-AD (Guy, 1976). This is a standard rating scale with 7-point global severity and change scales which has been modified for Autistic Disorder. A rating of 2 is given when there is a substantial reduction in symptoms so that a treating clinician would be unlikely to change treatment. A rating of 1 is reserved for patients who become virtually symptom-free. A rating of 3 (minimally improved) on the CGI is defined as slight symptomatic improvement that is not deemed clinically significant. Administration time is approximately 2 minutes. Minimum is 1 and maximum is 5. A lower score indicates improvement, whereas a higher score indicates worsening.
次要结局
- Aberrant Behavior Checklist(Administered biweekly, initial and week 8 reported)
研究者
Sherie Novotny, M.D.
Assistant Professor
Rutgers, The State University of New Jersey