Methylphenidate Efficacy and Safety in ADHD Preschoolers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 6
研究概览
简要总结
This research focuses on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in very young children. The medication being used is methylphenidate (Ritalin); it is being studied to determine its safety and how well it works to treat ADHD in preschool-age children (3-5.5 year olds).
详细描述
Young children age 3-5.5 years will be studied. The study includes treatment with different doses of methylphenidate and placebo; all children will receive active medication during the study. Prior to treatment, each child will receive a thorough psychiatric evaluation and each guardian will complete a 10-week workshop (2 hours/week). Throughout the study, parents and teachers will complete forms that report on the child's behavior and possible side effects. Participants will be monitored by regular visits with a study physician. Most participants will be involved in the study for up to 16 months to ensure optimal evaluation, dosing, and monitoring
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boys and girls who are:
- •Between the ages of 3-5.5 years
- •Qualified as having ADHD by our diagnostic evaluations and clinical staff
- •Otherwise generally healthy
- •Willing, and have parents that are willing, to attend all visits required by the study
- •Enrolled in some type of day-program: day care, preschool, nursery school, kindergarten, for at least 2 half days/week
- •In classrooms with teachers that are willing to participate by completing rating scale
排除标准
- 未提供
研究者
Laurence Greenhill
Professor of Clinical Child and Adolescent Psychiatry
New York State Psychiatric Institute