NCT00152022已完成3 期
A Phase III, Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-Group, Safety and Efficacy Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 412
- 主要终点
- The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects the participants sleep and how they perceive their quality of life.
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
- Double
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
- •Primary diagnosis of ADHD
- •Baseline ADHD-RS-IV score >= 32
- •Non-pregnant females of childbearing potential must comply with contraceptive restrictions.
排除标准
- •Significantly underweight or morbidly obese
- •Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Axis I disorders
- •History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder
- •Females who are pregnant or lactating
结局指标
主要结局
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
时间窗: Week 6
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
次要结局
- Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits(Baseline visit and weeks 1, 2, 3, 4, 5, & 6)
- Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits.(Baseline visit and weeks 1, 2, 3, 4, 5, & 6)
- Pittsburgh Sleep Quality Index (PSQI) - taken at every visit from Baseline to study completion.(Baseline visit and weeks 1, 2, 3, 4, 5, & 6)
- Clinical Global Impression of Improvement scale (CG(-I) - assessed at visits 1 through 6/Early Termination (ET)(Weeks 1, 2, 3, 4, 5, & 6)
研究者
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