NCT00332241已完成3 期
A Multicenter Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Otsuka Pharmaceutical Development & Commercialization, Inc.18 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2006年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 18
- 主要终点
- Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score
研究概览
简要总结
This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
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
- Double (Participant, Investigator)
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
- •Meets current Diagnostic and Statistical Manual for Mental Disorders-Fourth Edition (DSM-IV) diagnostic criteria for AD and demonstrates serious behavioral problems. Diagnosis confirmed by Autism Diagnostic Interview- Revised (ADI-R)
- •CGI score > = 4 AND and Aberrant Behavior Checklist (ABC) Irritability/Agitation subscale score > = 18 at screening and baseline (randomization)
- •Mental age of at least 18 months
- •Male or female 6 to 17 years of age, inclusive, at the time of randomization
排除标准
- •Patients considered treatment resistant to neuroleptic medication based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each.
- •Patients previously treated and not responding to aripiprazole treatment
- •The patient is currently diagnosed with another disorder on the autism spectrum, including PDD-NOS, Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or Childhood Disintegrative Disorder
- •Current diagnosis of bipolar disorder, psychosis, or schizophrenia, or major depression
- •A seizure in the past year
- •History of severe head trauma or stroke
- •Patients undergoing non-pharmacologic therapies (e.g., psychotherapy, behavioral modification) must have started at least 2 months prior to the initial screening visit and must remain in a consistent treatment program for the duration of the study.
研究组 & 干预措施
A2
Placebo Comparator
干预措施: Placebo (Drug)
A1
Experimental
Active Abilify
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score
时间窗: Week 8
The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement.
次要结局
- Mean Clinical Global Impressions Improvement Scale (CGI-I) Score(Week 8)
- Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)(Week 8)
- Change From Baseline in Body Weight(Week 8)
- Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores(Week 8)
- Summary of Safety(continuous throughout the study)
- Number of Participants With Response at Week 8(Week 8)
- Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)(Week 8)
研究者
研究点 (18)
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