NCT00485849已完成4 期
An Open Label Pilot Study of Atomoxetine for Attention Deficit and Hyperactive/Impulsive Behavior Problems in Children and Adolescents With Autistic Spectrum Disorders
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Test whether atomoxetine is effective in reducing symptoms of inattention and overactivity/impulsivity as measured by the AHDHRS-IV-Parent:Inv scale in pediatric outpatients with ASD accompanied by ADHD behavior problems
研究概览
简要总结
The primary purpose of this study is to evaluate the tolerability and effectiveness of atomoxetine in the treatment of attention problems, hyperactivity, and impulsivity in children with ASD, and secondarily, to evaluate the possible response to atomoxetine on the core symptoms of ASD
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Male and female outpatients between the ages of at least 6 years of age and not more than 17 years of age at visit 1
- •Autistic Spectrum Disorder (DSM-IV TR) diagnosis of Autistic disorder or Asperger syndrome or PDDNOS
- •Clinically significant symptoms of ADHD (i.e. inattention, impulsiveness, and hyperactivity) that have been present for at least six months (for subjects older than 8 years, the onset of symptoms must be before the age of 7 years)
- •Medication-free for at least two weeks for all psychotropic medications (four weeks for fluoxetine or depot-neuroleptics)
- •Patients must also be able to swallow capsules
排除标准
- •Patients who weigh less than 20 kg or greater than 60 kg at visit 2
- •DSM-IV TR diagnosis of a Pervasive Developmental Disorder other than Autistic Disorder, PDD-NOS, Asperger's Disorder (e.g. Rett's Disorder, Childhood Disintegrative Disorder)
- •Patients who have a history of Bipolar I or II disorder, schizophrenia, psychosis
- •Patients who have a current diagnosis of Major Depression (with or without psychotic features), PTSD
- •Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control
结局指标
主要结局
Test whether atomoxetine is effective in reducing symptoms of inattention and overactivity/impulsivity as measured by the AHDHRS-IV-Parent:Inv scale in pediatric outpatients with ASD accompanied by ADHD behavior problems
次要结局
- To assess whether atomoxetine will be effective in reducing symptoms of inattention and overactivity/impulsivity
- To assess whether atomoxetine will be effective for improving social functioning and personal sufficiency in children and adolescents with ASD+ADHD
- To assess whether atomoxetine has a positive or negative effect on frequently associated symptoms as impulsive aggression, agitation, self-injurious behavior, troublesome repetitive behavior and poor motor coordination
- To assess whether atomoxetine has a positive or negative effect on neuropsychological functioning
- To assess the overall influence on functioning and burden on the family
- To monitor clinical safety and side effects as assessed by adverse events elicited during open-ended questioning
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHDAttention-Deficit/Hyperactivity DisorderComorbid DyslexiaNCT00191048Eli Lilly and Company105
已完成
2 期
Atomoxetine Phase 2 Study in Japanese Adult Patients With Attention Deficit/Hyperactivity Disorder (ADHD)Attention Deficit Hyperactivity DisorderNCT00530335Eli Lilly and Company45
已完成
3 期
A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and AdolescentsAttention Deficit Hyperactivity DisorderNCT00447278Eli Lilly and Company399
终止
4 期
Pilot Evaluation of Atomoxetine on Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Adolescents With Cannabis abusECannabis AbuseAttention Deficit Hyperactivity DisorderNCT00687609Eli Lilly and Company7
已完成
2 期
Atomoxetine Asian Study in Adult Subjects With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention Deficit Hyperactivity DisorderNCT00636818Eli Lilly and Company45