A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Incomplete Block, Two-period, Crossover Clinical Trial to Study the Safety and Efficacy of MK0249, 10 mg, for Adult Patients, Ages 18 to 55, With Attention Deficit Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of an investigational treatment for Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.
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
- Double (Participant, Investigator)
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
- •Patient is between 18 and 55 years of age (inclusive)
- •Patient is an adult with a current DSM-IV diagnosis of ADHD of inattentive or combined subtype, as assessed via a structured interview using the ACDS and AISRS
- •Females of child-bearing potential must use acceptable methods of birth control during the study and for 1 month post-therapy
排除标准
- •Patient has a history of a neurological disorder resulting in ongoing impairment
- •Patient has a lifetime history of a psychotic disorder, bipolar disorder, or post-traumatic stress disorder
- •Patient has evidence of ongoing depression
- •Patient is sensitive or allergic to methylphenidate
- •Patient has glaucoma
- •Patient has a previous history of narrowing or blockage of the GI tract
- •Patient has a history of a sleep disorder (e.g., insomnia, sleep apnea, nightmares, or night terrors) within 6 months prior to screening
- •Patient has a history of a cardiovascular disorder within 6 months prior to screening
- •Patient has moderate or severe persistent asthma
- •Patient has a history of substance abuse or dependence not in sustained full remission for at least one year according to DSM-IV
- •Patient has taken part in a research study within the past 30 days of signing informed consent
研究组 & 干预措施
MK-0249
Total time in the study will be ~10 weeks.
干预措施: MK0249 (Drug)
Concerta
Total time in the study will be ~10 weeks.
干预措施: Concerta (methylphenidate) (Drug)
Placebo
Total time in the study will be ~10 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment
时间窗: after 4 weeks of treatment
The AISRS total score consists of 18 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which were derived based on Diagnostic and Statistical Manual-4 (DSM-IV) criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.
次要结局
- >/= 30% AISRS Total Score Responder Rate After 4 Weeks of Treatment;(after 4 weeks of treatment)
- Mean Change From Baseline in the AISRS Hyperactive/Impulsive Subscale Score(4 weeks of treatment)
- Mean Change From Baseline in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O:SV) Total ADHD Symptom Score.(4 weeks of treatment)
- >/=1-point Improvement in the CGI-S Score(4 weeks of treatment)
- Mean Change From Baseline in the Clinical Global Impressions-severity of Illness Scale(CGI-S) Score(4 weeks of treatment)
- Mean Change From Baseline in the AISRS Inattentive Subscale Score After 4 Weeks of Treatment(after 4 weeks of treatment)