Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Baseline to 2 Weeks ADHD Rating Scale
研究概览
简要总结
Primary: We hypothesize a clinically significant improvement in sleep latency, sleep-onset and total sleep time measures in adults with ADHD when given a trial of Ramelteon compared to placebo. Secondary:We expect that Ramelteon will show statistically significant improvements vs. placebo in measures of daytime sleepiness and with no decrement in daytime functioning, including such specific items as focus and social and occupational functioning.
详细描述
Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in adult ADHD subjects who suffer from initial insomnia.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ADHD and insomnia-
- •19-65 years of age
- •In good general health
- •Negative pregnancy test
排除标准
- •Current primary psychiatric diagnosis other than ADHD
- •Positive urine drug screen for any sedative hypnotic or drugs of abuse
- •Unstable medical condition
- •HIV positive
- •Seizure disorder
- •Known hypersensitivity to Ramelteon
研究组 & 干预措施
Ramelteon then placebo
8 mg tablets every night for 2 weeks, then a 2 week washout,then crossover to placebo tablets for 2 weeks.
干预措施: Ramelteon (Drug)
Placebo then Ramelteon
placebo tablets for every night for 2 weeks, then a 2 week washout, followed by 8 mg tablets every night for 2 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Baseline to 2 Weeks ADHD Rating Scale
时间窗: day 1 to day 14 of study drug
It is an 18 item scale with 9 symptoms of inattention and 9 symptoms of Impulsivity and Hyperactivity. This scale is the gold standard in assessment of ADHD. Scores range from 0-54. There must be a score of 6 or more in either category to be diagnosed with ADHD. Severity ranges: 6-18 mild, 19-36 moderate, 37-54 severe. The outcome measure is the percentage difference between the total day 1 score for all subjects and the total 14 day score for all subjects.
次要结局
- Change in Clinical Global Impression (CGI)(day 1 to day 14 of study drug)
研究者
Rachel Fargason, MD
Associate Professosr
University of Alabama at Birmingham