NCT00485550已完成3 期
A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride Augmented With Either Extended-Release Methylphenidate Hydrochloride (Concerta-TM) or Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) Who Have Not Responded to Stimulant Mono Therapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Assess the safety of atomoxetine and placebo compared to atomoxetine and methylphenidate in children aged 6 through 12 years with ADHD who have been identified as stimulant non-responders and have been exposed to acute treatment of atomoxetine.
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of atomoxetine alone versus atomoxetine plus low-dose, sustained-release MPH in children with treatment-resistant ADHD.
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
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be at least 6 years of age and not more than 12 years of age at visit 1
- •Patients must meet DSM-IV diagnostic criteria for ADHD
- •Patients must be retrospectively identified as stimulant non-responders
- •Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgment, to achieve a score of greater than or equal to 70 on an IQ test)
- •Patients must be able to swallow capsules
排除标准
- •Patients who weigh less than 22 kg or more than 60 kg at study entry
- •Patients who have a history of Bipolar I or Bipolar II Disorder, psychosis, or pervasive developmental disorder
- •Patients who meet DSM-IV criteria for anxiety disorder or autism
- •Patients with a history of any seizure disorder and/or Rolandic seizures (other than febrile seizures) or prior electroencephalogram (ECG) abnormalities in the absence of seizures, or patients who have taken (or are currently taking) anticonvulsants for seizure control
- •Patients with a history of severe allergies to more than one class of medication or multiple adverse drug reactions, including hypersensitivity to MPH
结局指标
主要结局
Assess the safety of atomoxetine and placebo compared to atomoxetine and methylphenidate in children aged 6 through 12 years with ADHD who have been identified as stimulant non-responders and have been exposed to acute treatment of atomoxetine.
次要结局
- Assess the safety of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children retrospectively identified as stimulant non-responders as measured by ECGs
- Assess the safety of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children retrospectively identified as stimulant non-responders as measured by clinical laboratory tests
- Assess the tolerability of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children retrospectively identified as stimulant non-responders as measured by spontaneously reported AEs
- Compare the efficacy of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODDOppositional Defiant DisorderAttention Deficit Hyperactivity DisorderNCT00191698Eli Lilly and Company226
已完成
4 期
Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents With Autism Spectrum DisorderAutistic DisorderAttention Deficit Disorder With HyperactivityNCT00380692Eli Lilly and Company97
已完成
2 期
Efficacy and Tolerability of Atomoxetine (Strattera) in Adult Patients With Generalized Social Anxiety DisorderGeneralized Social PhobiaNCT00260533University of California, San Diego27
已完成
3 期
Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With ADHDAttention Deficit Hyperactivity DisorderNCT00486083Eli Lilly and Company330
已完成
2 期
Effects of Atomoxetine in Mild Cognitive ImpairmentMild Cognitive ImpairmentNCT01522404Emory University39