NCT00564954已完成4 期
A Randomized, Multi-center, Double-blind, Cross-over Study Comparing the Efficacy and Safety of Focalin® XR 20 mg Versus Placebo at the 0.5 Hour Timepoint (Post-dose) in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change From Pre-dose (0 hr [Hour]) on the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) Rating Scale Combined Score at 0.5 Hour During the 8- Hour Laboratory Classroom Day
研究概览
简要总结
This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged 6-12 years, inclusive.
- •Subjects meeting the DSM-IV criteria for ADHD of any type, as established by the K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version). If a DSM-IV-defined ADHD diagnosis is difficult to establish due to possible co-morbidity, the subject will not be enrolled into the study.
- •Subjects should be on a stabilized total daily dose or nearest equivalent of 40-60 mg methylphenidate or 20-30 mg of d-methylphenidate for at least two weeks prior to screening visit (Concerta® 36 mg and 54 mg is allowable)
排除标准
- •Parent or guardian unable or unwilling to complete the Conner's ADHD/DSM-IV Scale for Parents (CADS-P) and the Daily Diary Card
- •Diagnosed with a tic disorder or Tourette's syndrome
- •History of seizure disorder
- •The presence of a known medical condition that would preclude the use of methylphenidate. A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease
- •ALT, AST, GGPT or serum creatinine greater then 2X the ULN at Screening
- •A history of psychiatric illness or substance use disorder (e.g., schizophrenia, bipolar disorder, autism, abuse or dependence, depression, severe Conduct Disorder or severe Oppositional defiant disorder)
- •Subjects who have participated in an investigational trial within the past 4 weeks (28 days) are excluded
- •Subjects who are currently taking antidepressants or other psychotropic medication
- •Subjects who have initiated psychotherapy during the three months prior to randomization
- •Subjects with a positive urine drug screen
- •Subjects who have a history of poor response or intolerance to methylphenidate or d-methylphenidate
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Dex-methylphenidate hydrochloride (Focalin XR)
Experimental
20 mg capsule orally once a day for 7 days
干预措施: Dex-methylphenidate hydrochloride extended-release (Focalin XR) (Drug)
Placebo
Placebo Comparator
orally once a day for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Pre-dose (0 hr [Hour]) on the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) Rating Scale Combined Score at 0.5 Hour During the 8- Hour Laboratory Classroom Day
时间窗: 0 hr and 0.5 hr post-dose
SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.
次要结局
- Change From Pre-dose (0 hr.) in Permanent Product Measure of Performance (PERMP) Math Test-Attempted Scores at All Timepoints (0.5, 1, 2, 4, 6, 8)(0, 0.5, 1, 2, 4, 6 and 8 hours)
- Change From Pre-dose (0 hr) in SKAMP Combined Score at All Times Excluding the 0.5 Hour Timepoint (Hours 1, 2, 4, 6, 8)(0, 1, 2, 4, 6, and 8 hr)
- Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)(0, 0.5, 1, 2, 4, 6, and 8 hours)
- Change From Pre-dose in SKAMP Deportment Score(0, 0.5, 1, 2, 4, 6 and 8 hours)
- Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test(0, 0.5, 1, 2, 4, 6 and 8 hours)
研究者
研究点 (1)
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