NCT00191698已完成3 期
A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride and Placebo in Child and Adolescent Outpatients With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Mean reduction in ODD symptoms using the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV), atomoxetine vs placebo
研究概览
简要总结
The purpose of this trial is to test the effectiveness of atomoxetine in treating symptoms of ODD in children with ADHD and ODD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients are male or female outpatients who are at least 6 years of age and not more than 12 years of age at study entry.
- •Patients must meet DSM-IV diagnostic criteria for ADHD and ODD.
- •If other comorbid conditions are present, either the ADHD or the ODD diagnosis must be the patient's primary diagnosis.
- •Patients must have laboratory results, including serum chemistries, hematology, and urinalysis showing no significant abnormalities.
- •Patients must have an ECG performed at study entry that is absent of any abnormality that, in the opinion of the physician, should exclude the patient.
排除标准
- •Patients who weigh less than 20 kg or greater than 60 kg at study entry.
- •Patients who have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder.
- •Patients who have a current diagnosis of Major Depressive Disorder ([MDD]; with or without psychotic features), PTSD, or CDRS-R total raw score >40 at study entry.
- •Patients with a history of any seizure disorder.
- •Patients determined by the investigator to be at serious suicidal risk.
研究组 & 干预措施
A
Experimental
Atomoxetine is administered at 1.2 mg/kg/day, PO for 8 weeks, followed by 1.2 or 2.4 mg/kg/day, PO for 4 weeks, open label administration can continue for up to one year
干预措施: atomoxetine hydrochloride (Drug)
B
Placebo Comparator
Placebo is administered by mouth, daily for 8 weeks. After 8 weeks, those randomized to placebo may be titrated to 1.2 mg/kg/day atomoxetine for the remainder of the study up to one year
干预措施: placebo (Drug)
结局指标
主要结局
Mean reduction in ODD symptoms using the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV), atomoxetine vs placebo
时间窗: over 8 weeks
次要结局
- Adverse events (AEs)(over 1 year)
- Mean change in the investigator-rated SNAP-IV ADHD subscales, atomoxetine vs placebo(over 8 weeks)
- Mean change in ratings on the Oppositional subscale of the SNAP-IV(over 8 weeks)
- Mean change in ADHD symptoms by ADHD subscales of the SNAP-IV, 2.4 mg/kg/day vs 1.2 mg/kg/day.(over 4 weeks)
- Mean change in ratings on the Clinical Global Impressions-Severity (CGI-S).(over 8 weeks)
- Psychosocial functioning as measured by the total score on the Attention Deficit Hyperactivity Disorder Impact Module (AIM).(over 8 weeks)
- Environmental stress exacerbation of ODD symptoms by Social Readjustment Rating Scale (SRRS).(8 weeks, 12 weeks)
研究者
研究点 (1)
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