Open-Label Treatment Trial to Assess the Short-Term Tolerability, Safety, and Efficacy of Methylphenidate Hydrochloride Extended-Release Liquid Formulation in High-Functioning Autism Spectrum Disorder Adults With Attention-Deficit/Hyperactivity Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Adult ADHD Investigator Symptom Report Scale (AISRS) Score
研究概览
简要总结
The purpose of this study is to determine whether methylphenidate hydrochloride extended release liquid formulation is safe and effective in the treatment of attention-deficit/hyperactivity disorder (ADHD) in high-functioning adults with autism spectrum disorders (ASD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Methylphenidate extended-release liquid
Methylphenidate extended-release liquid formulation
干预措施: Methylphenidate extended-release liquid formulation (Drug)
结局指标
主要结局
Change in Adult ADHD Investigator Symptom Report Scale (AISRS) Score
时间窗: Baseline to 6 weeks
The Adult ADHD Investigator Symptom Report Scale (AISRS) assesses each of the 18 individual symptoms of ADHD in DSM-IV on a Likert scale from 0 (not present) to 3 (severe), with a total possible score of 54. The change in AISRS score from baseline to endpoint (6 weeks) was calculated as the later time point score minus the earlier time point score.
次要结局
未报告次要终点
研究者
Gagan Joshi
Assistant professor of Psychiatry, Harvard Medical School; Director, Autism Spectrum Disorder Clinical & Research Program, Pediatric Psychopharmacology
Massachusetts General Hospital