NCT00391729已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
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
- Abbott
- 入组人数
- 221
- 主要终点
- Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score
研究概览
简要总结
The objective of this study is to compare the safety and efficacy of five doses of ABT-089 (2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD and 40 mg BID) to placebo in adults with ADHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet criteria for attention deficit hyperactivity disorder
- •Have voluntarily signed an informed consent form
- •Are between 18 and 60 years of age
- •Will use contraceptive methods during the study
- •Women must not be pregnant or breast-feeding
- •Must be in generally good health
- •Are fluent in English
排除标准
- •They have a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder or mental retardation
- •They have a current diagnosis of major depressive episode, generalized anxiety disorder (GAD), or post-traumatic stress disorder (PTSD) or have a clinically significant sleep disorder requiring treatment
- •They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants or mood stabilizers
- •They failed to respond to two or more adequate trials of FDA-approved ADHD medication
- •They have violent, homicidal or suicidal ideation
- •They have a significant history of medical diagnoses, seizure disorder, Tourette's syndrome or a central nervous system (CNS) disease, excluding ADHD
- •They have a urine drug screen that is positive for alcohol or drugs of abuse
- •They have a history of substance or alcohol disorder (abuse/dependence) during the last 3 months
研究组 & 干预措施
1
Placebo Comparator
干预措施: Placebo (Drug)
2
Experimental
干预措施: ABT-089 (Drug)
结局指标
主要结局
Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score
时间窗: at the final evaluation of each 4-week treatment period
次要结局
- CAARS Inattentive and Hyperactive/Impulsive Sub scales Scores(at the final evaluation of each 4-week treatment period)
- CAARS ADHD Index, CAARS:Self(at the final evaluation of each 4-week treatment period)
- CGI-ADHD-S, AISRS, TASS, FTND(at the final evaluation of each 4-week treatment period)
- QSU-Brief, CANTAB cognitive battery(at the final evaluation of each 4-week treatment period)
研究者
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