EUCTR2015-001084-39-Outside-EU/EEA进行中（未招募）不适用
Efficacy and learning skill after OROS Methylphenidate treatment in adolescents with Attention-Deficit/Hyperactivity Disorder: A 12-week, multi-center, open-label study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 125
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
- •- Participants must meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for Attention Deficit Hyperactivity Disorder (ADHD) and are considered to require medication therapy
- •- Participants that agreed to observe visit schedules and willingly complete the evaluation defined by participant (possibly to be completed by parents/guardians) during the treatment period
- •- Participants and parents/guardians that are able to understand the participation procedures of the research and spontaneously request the discontinuation therein at any time
- •- Participants that offered spontaneous consent for participation
- •- Participants whose guardian/legal representative provided spontaneous written consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 115
- •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
- •- Hypersensitivity to methylphenidate HCl
- •- Participants diagnosed with major depression or anxiety disorders according to DSM-IV Diagnostic criteria and who requires drug therapy
- •- Participants with a history of bipolar disorder, psychotic disorder, and substance abuse disorder ordiagnosed with an overall developmental disorder, organic brain disorder, seizure (sudden, uncontrolled muscle spasms and loss of consciousness resulting from abnormal brain function) disorder, movement disorder requiring the medication therapy, or with a family history of Tourette's syndrome (a neuropsychological disorder that causes marked distress or significant impairment in social, occupational, or other important areas of functioning)
- •- Taken Osmotic Release Oral System (OROS) Methylphenidate within 3 months prior to screening
- •- Currently taking alpha-2 adrenergic receptor agonist, antidepressant, antipsychotic, benzodiazepines, modafinil, anticonvulsant (drug used to stop seizures) or health food supplements that may have a central nervous system activity
研究者
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