EUCTR2017-000740-18-Outside-EU/EEA进行中(未招募)1 期
Evaluation of Academic Performance in Asian Children Aged 8 to 11 Years With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine Hydrochloride
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female outpatients between 8 and 11 years of age at study entry
- •Attention-Deficit/Hyperactivity Disorder (ADHD) meeting the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) disease diagnostic criteria
- •Patients who have never received medications psychotropic medications specifically to treat ADHD, or if they have received medication, that the trial of the psychotropic medication(s) was of less than 1 month duration, and occurred more than 6 months prior to study entry
- •Normal intelligence in the judgment of the investigator
- •Must be able to swallow capsules
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 228
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Current or past history of bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or conduct disorder
- •History of seizure disorder or currently taking anticonvulsants for seizure control
- •Serious suicidal risk as determined by investigator
- •Cardiovascular disease; current or past history of hypertension
- •Previous treatment with atomoxetine
研究者
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