A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning Using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder in Treatment-Naïve Children and Adolescents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 399
- 试验地点
- 1
- 主要终点
- Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain
研究概览
简要总结
The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder [ADHD]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.
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
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •6 to 16 years old
- •Diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM IV) confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (SADS PL)
- •Pharmacological naïve
- •Normal intelligence as assessed by investigator
- •Each patient (and/or legally authorized patient representative where required by local law) must understand the nature of the study and must sign an Informed Consent Document.
排除标准
- •Exclusion criteria
- •History of bipolar disorder, any history of psychosis or autism spectrum disorder
- •History of any seizure disorder
- •Significant prior or current medical conditions
- •History of alcohol or drug abuse within the past 3 months
- •Patients who are taking concurrently any of the excluded medications in the study.
研究组 & 干预措施
Atomoxetine
0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
干预措施: Atomoxetine (Drug)
OEST
Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
干预措施: Other standard therapy for ADHD (Drug)
结局指标
主要结局
Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain
时间窗: Baseline, 6 months
CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
次要结局
- Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain(Baseline, 4 months, 12 months)
- Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)(Baseline, 4 months, 6 months, 12 months)
- Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)(Baseline, 4 months, 6 months, 12 months)
- Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)(Baseline, 4 months, 6 months, 12 months)
- Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)(Baseline, 4 months, 6 months, 12 months)
- Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)(Baseline, 4 months, 6 months, 12 months)
- Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)(Baseline, 4 months, 6 months, 12 months)
- Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores(Baseline, 6 months)