NCT01174355已完成1 期
A Multicenter, Open Label, Escalating Dose Study to Assess the Tolerability and the Safety and to Explore the Efficacy and the Pharmacokinetics of ND0801 in Adult Patients With Attention Deficit/Hyperactivity Disorder (ADHD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Safety & Tolerability Evaluation
研究概览
简要总结
A multicenter, open label, escalating dose study to assess the tolerability and the safety and to explore the efficacy and the pharmacokinetics of ND0801 in adult patients with attention deficit/hyperactivity disorder (ADHD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients.
- •Men and women 18-55 years of age.
- •Primary DSM-IV diagnosis of adult ADHD confirmed by senior physician
- •Capable and willing to provide informed consent
- •Able to adhere to the treatment schedule, and withdrawal of ongoing pharmacotherapy for the treatment of ADHD prior to the beginning of the study treatment and during the study drug treatment.
- •Subjects must be able to read, hear, write and speak the local language.
- •Subject has signed a written informed consent to participate in the study.
排除标准
- •Unstable or significant medical disorder.
- •Current (within 12 months of baseline) primary or secondary depression.
- •History of substance abuse or dependence within the past 6 months
- •Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features
- •Bipolar disorder
- •Eating disorder
- •Obsessive compulsive disorder
- •Post-traumatic stress disorder
- •Current generalized anxiety disorder
- •Presence of a personality disorder
- •Individuals with a significant other neurological disorder.
- •Use of any investigational drug within 4 weeks of the randomization visit
- •Known or suspected pregnancy
- •Women who are breast-feeding
- •Women of childbearing potential and not using a medically accepted form of contraception
研究组 & 干预措施
ND0801
Experimental
干预措施: ND0801 (Drug)
结局指标
主要结局
Safety & Tolerability Evaluation
时间窗: 1 week
Safety and tolerability of ND0801 will be based on adverse events reporting by the subjects during the study.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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