NCT00640185已完成2 期
A Pilot, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety, Tolerability and Efficacy of 40 mg QD and 80 mg QD ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD)
AbbVie (prior sponsor, Abbott)12 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 12
- 主要终点
- CAARS: Inv Total Score
研究概览
简要总结
The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have voluntarily signed an informed consent form.
- •Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with subject.
- •Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
- •Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
- •Male subjects must agree to comply with applicable contraceptive requirements.
- •Subject is able to keep required appointments for clinic visits and all tests, including blood draws and examinations.
排除标准
- •Subject has a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder.
- •Current diagnosis of major depressive disorder, generalized anxiety disorder, PTSD or has a sleep disorder requiring treatment of any kind.
- •Subject has a history of, or ongoing, serious medical problem.
- •Subject has a history of significant allergic reaction to any drug.
- •Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD.
- •Subject requires ongoing treatment with any psychiatric medication.
研究组 & 干预措施
1
Placebo Comparator
干预措施: Placebo (Drug)
2
Experimental
干预措施: Placebo (Drug)
3
Experimental
干预措施: Placebo (Drug)
2
Experimental
干预措施: ABT-089 (Drug)
1
Placebo Comparator
干预措施: ABT-089 (Drug)
3
Experimental
干预措施: ABT-089 (Drug)
结局指标
主要结局
CAARS: Inv Total Score
时间窗: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56
次要结局
- CAARS Inattentive and Hyperactive/Impulsivity Sub-scale scores, CAARS ADHD Index, CGI-ADHD-S, AISRS, CAARS:Self(Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56)
- TASS, AAQoL, WPAI(Day -1, Day 28, Day 56)
- BRIEF-A, FTND(Day-1, Day 56)
- QSU-Brief, Number of Cigarettes smoked per day(Day -1, Day 7, Day 14, Day 28, Day 42, Day 56)
研究者
研究点 (12)
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