A Randomized, Double-Blind Comparison of Atomoxetine Versus Placebo in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score
研究概览
简要总结
A three-arm, randomized, double-blind, placebo-controlled, Phase 4, multicenter study to compare the efficacy and safety of atomoxetine versus placebo in children and adolescents aged 6 through 17 years with attention-deficit/hyperactivity disorder (ADHD) and comorbid oppositional defiant disorder (ODD) who are treated as outpatients in Germany. After an initial 3- to 28-day screening and washout phase, participants will be assigned to double-blind treatment with atomoxetine or placebo. A 2 week up-titration period will be succeeded by a 7 week treatment period at the target dose. The primary efficacy measure will be the Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) ODD subscale score.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 or female outpatients who are at least 6 years of age, and who will not have reached their 18th birthday
- •Diagnosis of ADHD and presence of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria A through C for ODD (NOTE: diagnosis for conduct disorder not exclusionary)
- •Normal intelligence
- •Able to swallow capsules
排除标准
- •Weigh less than 20 kilogram (kg) or more than 90 kg at study entry
- •Prior treatment with atomoxetine
- •History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months
- •History of severe allergies or multiple adverse drug reactions
- •Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT (measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle) prolongation , inherited cardiac disorders
研究组 & 干预措施
Atomoxetine Fast Titration
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
干预措施: Atomoxetine (Drug)
Atomoxetine Slow Titration
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
干预措施: Atomoxetine (Drug)
Placebo
matching placebo daily dose taken orally
干预措施: Placebo (Drug)
结局指标
主要结局
Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score
时间窗: 9 weeks
The SNAP-IV, a 26-item scale, includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD. Each item is scored on a 0 to 3 scale (0=Not at All, 1=Just a Little, 2=Pretty Much, 3=Very Much). The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperact-ivity/Impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). SNAP-IV: ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54.
次要结局
- Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score(9 weeks)
- Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Score(9 weeks)
- Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score(9 weeks)
- Parent-Rated Attention-Deficit Scale (FBB-HKS), Total Score: Severity(9 weeks)
- Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity(9 weeks)
- Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score(9 weeks)
- Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score(9 weeks)
- Impact on Family Scale (FaBel), Total Impact Score(9 weeks)
- Clinical Global Impressions - Severity (CGI-S): ADHD Score(9 weeks)
- Clinical Global Impressions - Severity (CGI-S): ODD Score(9 weeks)
- Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores(9 weeks)
- German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score(9 weeks)
- German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score(9 weeks)
- German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score(9 weeks)
- German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score(9 weeks)
- German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score(9 weeks)
- German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score(9 weeks)
- German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score(9 weeks)
- Number of Participants Discontinuing Treatment(9 weeks)
- Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment(3 weeks)
- Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period(9 weeks)