A Double-Blind Placebo Controlled Study of Atomoxetine Hydrochloride for the Treatment of ADHD in Children and Adolescents With ADHD and Comorbid Dyslexia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 1
- 主要终点
- Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint
研究概览
简要总结
This study will evaluate the effect of atomoxetine in treating Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children and adolescents with ADHD and comorbid reading disability (dyslexia)
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
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD)
- •patients must achieve a score of 80 or more on the Full Scale Intelligence Quotient
- •child or adolescent patients must be 10 to 16 years old
- •must be able to communicate in English
- •must be able to swallow capsules
- •be reliable to keep appointments for clinic visits and all related tests
排除标准
- •patients who weigh less than 25 Kg or greater than 70 Kg
- •patients with a history of alcohol or drug abuse on a repeated basis within the past 3 months
- •patients with documented history of autism, Asperger's syndrome or pervasive developmental disorder
- •females who are pregnant or breastfeeding
- •patients with a history of severe allergy to more than one class of medications
- •patients with documented history of bipolar I or bipolar II disorder, or psychosis
研究组 & 干预措施
Atomoxetine
Atomoxetine will be administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning. All eligible patients who complete the double-blind study period will have the option of participating in a 16-week open-label extension period in which patients will be treated with atomoxetine
干预措施: Atomoxetine (Drug)
Placebo
Placebo will be packaged in the same way as experimental drug to enforce double-blind study design. Placebo will be administered orally once daily in the morning. All eligible patients who complete the double-blind study period will have the option of participating in a 16-week open-label extension period in which patients will be treated with atomoxetine.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint
时间窗: Baseline, 16 weeks
Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0-54. Least Square mean of change from baseline in ADHDRS is from a restricted maximum likelihood-based, mixed model repeated measures analysis which includes the effects of treatment, investigative site, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
次要结局
- Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint(Baseline, 32 weeks)