Efficacy, Safety and Tolerability of Zolpidem in the Treatment of Children Aged 6 to 17 Years With ADHD-Associated Insomnia. A Multicentre, Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Latency to persistent sleep (LPS) measured by polysomnography
研究概览
简要总结
There has been an increased interest in the association between ADHD and sleep disorders over the past years. A high incidence of sleep disturbance, ranging from 10% to 70%, has been identified in ADHD children regardless of whether or not they are receiving stimulant therapy. This study will assess the safety and efficacy of zolpidem in children with ADHD associated insomnia.
详细描述
The study is being conducted in the United States. It consists of 3 segments:
- Segment A: 2 to 21 day screening period
- Segment B: 8-week double-blind treatment period
- Segment C: 1-week follow-up period
Subjects will have a polysomnography in a sleep lab two times during the study (at baseline and between visit 4-5) and also be required to wear an actigraphy monitoring tool. There will be several questionnaires completed throughout the study: CGI-child, CGI-parent/legal guardian, ADHD Rating Scale-IV, and the Pediatric Daytime Sleepiness Scale.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the ages of 6 and 17 years, inclusive
- •Children with diagnosed ADHD (as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision [DSM-IV-TR] criteria)
- •Complaint of childhood insomnia as defined by repeated difficulty with sleep initiation or consolidation that occurs despite adequate age, appropriate time, and opportunity for sleep
- •The sleep disturbance must not be attributable to either the direct physiologic effect of drug abuse or misuse of a prescribed medication.
- •Subjects should be stabilized on all long-term therapy, including treatment of ADHD, for at least one month prior to study entry.
- •Subjects, if females of childbearing potential (as determined by the initiation of menses), must have confirmed negative pregnancy test prior to randomization and be using a recognized effective method of birth control (oral, implant, depot or transdermal oestroprogestatives, intrauterine device, double-barrier with spermicide). Abstinence is an acceptable method of birth control for this study.
排除标准
- •Mental retardation
- •Autistic spectrum disorder
- •A history of sleep apnea
- •A history of bipolar disorder, conduct disorder, major depression, or generalized anxiety disorder (not obsessive compulsive disorder), as determined by clinical interview and DSM-IV-TR criteria
- •Current history of substance abuse/dependence
- •Known hypersensitivity to zolpidem or previous adverse experience with zolpidem
- •Pregnant or breast-feeding
- •Current use of hypnotics, antihistamines, melatonin, herbal products, or other sleep aids
结局指标
主要结局
Latency to persistent sleep (LPS) measured by polysomnography
次要结局
- Clinical Global Impression (CGI) Severity and Global Improvement item scores (from child and parent/legal guardian scales)
- Actigraphy measures of sleep characteristics
- ADHD Rating Scale-IV
- School tardiness/Attendance Reports
- Adverse events
- PE, lab