An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The Total Symptoms Scale Score (of ADHD) of the Connors Adult ADHD Rating Scale-Investigator Rating (CAARS-INV).
研究概览
简要总结
A 3-way cross-over trial of two weeks of treatment with three drug conditions. AZD3480 will be given in doses of (A) 5mg/day, (B) 50 mg/day and (C) placebo to 24 non-smoking adults with DSM-IV confirmed ADHD. Three week washout between each treatment period. CYP2D6 genotyping will be completed at screening and slow metabolisers will be excluded from participation in this study. Cognitive, ADHD symptom, safety and pharmacokinetic (PK) assessments will be made during each treatment period. Safety and tolerability assessments will be a major component of the trial and all serious adverse events (SAE) will be immediately (within 24 hours) reported to both Targacept and to AstraZenca.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of DSM-IV ADHD
- •Score of equal or more than 2 on at least six of nine items in at least one of the subscales of the Connor´s Adult ADHD Rating Scale (CAARS-INV)
- •Score of equal or more than 4 (at least moderate severity) on the Clinical Global Impressions-Severity (CGI-S) test
排除标准
- •Current DSM-IV Axis I psychiatric disorder (other than ADHD)
- •Current user of cigarettes or other nicotine-containing product.
- •Slow metabolizers as indicated by CYP2D6 genotyping.
- •Use of drugs affecting cognitive function within 8 weeks prior to enrollment visit or intended use during the study.
研究组 & 干预措施
1
干预措施: Placebo (Drug)
2
干预措施: AZD3480 (Drug)
3
干预措施: AZD3480 (Drug)
结局指标
主要结局
The Total Symptoms Scale Score (of ADHD) of the Connors Adult ADHD Rating Scale-Investigator Rating (CAARS-INV).
时间窗: Visit 1, 2, 3, 4, 5, 8, 9, 10,13, 14 and 15
次要结局
- Clinical Global Impressions Scales (NIMH 1985)(Visit 1, 2, 3, 4, 5, 8, 9, 10, 13, 14,15)
- CDR computerized cognitive battery(2, 3, 5, 8, 10, 13, 15)
- CNRU computerized cognitive battery(2, 3, 5, 8, 10, 13, 15)