A Randomised, Controlled, Open-Label Study of the Broader Efficacy of Atomoxetine Hydrochloride in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents

Eli Lilly and Company2 个研究点分布在 1 个国家目标入组 200 人开始时间: 2004年6月1日最近更新: 2007年3月2日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Eli Lilly and Company
入组人数: 200
试验地点: 2
主要终点: To test whether atomoxetine given for 10 weeks is superior to standard current therapy as measured by CHIP-CE (Child Health and Illness Profile - Child Edition)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To test the hypothesis that children/adolescents with ADHD, who are treated with atomoxetine hydrochloride in comparison to standard current therapies have greater improvements in their quality of life.

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: None

入排标准

年龄范围: 7 Years 至 15 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosis of ADHD

排除标准

•Patients who weigh less than 20kg at visit 1
•Have Bipolar Disorder/seizure disorder/taken anticonvulsants for seizures
•Judged to be at suicidal risk
•Taking psychotropic medication on a regular basis
•Hypertension

结局指标

主要结局

To test whether atomoxetine given for 10 weeks is superior to standard current therapy as measured by CHIP-CE (Child Health and Illness Profile - Child Edition)

次要结局

CHIP-CE total mean score after 4 weeks of treatment.
The domains of the CHIP-CE after 4 and 10 weeks of treatment.
The following are measured after both 4 and 10 weeks of treatment:
Family Buden of Illness
Harter Self Perception Profile
ADHD-RS
Clinical Global Impression- Severity
Clinical Global Impression -Improvement
To assess whether changes to the above scales are maintained over long term
Long-term safety of atomoxetine

研究者

发起方

Eli Lilly and Company

申办方类型

Industry

研究点 (2)

Loading locations...

相似试验

已完成

4 期

Study of Atomoxetine in Children With ADHD to Assess Symptomatic and Functional OutcomesAttention-Deficit/Hyperactivity Disorder

NCT00191633Eli Lilly and Company200

终止

4 期

Pilot Evaluation of Atomoxetine on Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Adolescents With Cannabis abusECannabis AbuseAttention Deficit Hyperactivity Disorder

NCT00687609Eli Lilly and Company7

已完成

2 期

Atomoxetine Versus Placebo in Children With Attention Deficit/Hyperactivity Disorder (ADHD)Attention Deficit Hyperactivity Disorder

NCT00191295Eli Lilly and Company240

已完成

4 期

Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional OutcomesAttention Deficit Hyperactivity Disorder

NCT00510276Eli Lilly and Company445

已完成

4 期

Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young ChildrenAttention Deficit Disorder With Hyperactivity

NCT00254462University of Nebraska93