NCT00485875已完成4 期
An Open-Label, Multicenter, Pilot Study of the Safety and Efficacy of Transitioning From a Stimulant Medication to Atomoxetine in Pediatric and Adolescent Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder (ADHD)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Assess the change in ADHD symptoms when switching from stimulant medication to atomoxetine among patients who cannot tolerate or do not respond to stimulants and require a medication change
研究概览
简要总结
The purpose of this study is to assess changes in ADHD symptoms and tolerability of medication in children and adolescents switching from a stimulant to atomoxetine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients must be at least 6 years of age and not yet be 18 years of age at the completion of visit 6
- •Patients must meet DSM-IV diagnostic criteria for ADHD (any subtype)
- •Patients must have laboratory results showing no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation)
- •Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgment, to achieve a score of greater than or equal to 70 on a IQ test)
- •Patients must be able to swallow capsules
排除标准
- •Patients who weigh less than 22 kg or more than 70 kg at study entry
- •Patients who have a history of Bipolar I or Bipolar II Disorder, psychosis, or a pervasive developmental disorder
- •Patients with a history of any seizure disorder (other than febrile seizures) or prior EEG abnormalities related to epilepsy, or patients who have taken (or are currently taking) anticonvulsants for seizure control
- •Patients with a history of severe allergies to more than one class of medication, or multiple adverse drug reactions
- •Patients who have glaucoma
结局指标
主要结局
Assess the change in ADHD symptoms when switching from stimulant medication to atomoxetine among patients who cannot tolerate or do not respond to stimulants and require a medication change
次要结局
- Assess whether there are statistically significant differences in ADHD symptom measures after a patient changes from a stimulant medication to atomoxetine
- Assess the safety and tolerability of atomoxetine alone compared with stimulant medications alone and during the time of switch (stimulant plus atomoxetine) as assessed by AEs elicited during open-ended questioning.
- Compare atomoxetine and stimulant medications on other secondary measures, including parent preference
- Assess whether there is a significant change in problem behaviors related to ADHD after switching from stimulant medication to atomoxetine
- Assess the change in inattentive and hyperactive symptoms among these same patients
研究者
研究点 (2)
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