NCT00940693已完成2 期
Pilot Study of the Efficacy of Duloxetine in Treating Adults With Attention Deficit Hyperactivity Disorder: a Randomized, Controlled Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Impact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Observer Report:Screening Version (CAARS-O:SV) in adult ADHD subjects.
研究概览
简要总结
The purpose of this study is to determine whether duloxetine is an effective treatment of attention deficit disorder in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of ADHD of at least moderate intensity
- •Able to give consent
- •Able to swallow capsules
排除标准
- •Allergic or do not tolerate duloxetine
- •Under psychotherapy for ADHD
- •Taking a medication that interacts with duloxetine, including all psychotropic medication
- •Treated with medication for ADHD
- •Unstable medical condition
- •Severe renal insufficiency
- •Liver insufficiency
- •Substance/alcool abuse or dependency in the last 6 months
- •Pregnancy, nursing or inadequate contraceptive methods
- •Suicide or homicide risk
- •Organic brain syndrome
- •Any diagnosis of lifetime bipolar disorder or psychotic disorder, and any actual diagnosis of anxious disorder or major depressive disorder
研究组 & 干预措施
duloxetine
Active Comparator
干预措施: duloxetine (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Impact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Observer Report:Screening Version (CAARS-O:SV) in adult ADHD subjects.
时间窗: baseline and week 6
次要结局
- Impact of duloxetine on the Clinical Global Impression Scale in ADHD adults(baseline and week 6)
- Impact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report : Long Version(44) (CAARS-S:L), in adult ADHD subjects.(baseline and week 6)
- Impact of duloxetine on anxious and depressive symptoms in adult ADHD subjects.(baseline and week 6)
- Impact of duloxetine on Quality of life in adults with ADHD(baseline and week 6)
- Impact of duloxetine on executive functions and cognitive performances in adults with ADHD(baseline and week 6)
研究者
研究点 (1)
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