Quillivant XR in Children With Attention Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD): A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- ADHD Rating Scale - IV
研究概览
简要总结
The purpose of this study is to determine whether Quillivant XR is effective in the treatment of ADHD in children with Autism Spectrum Disorder (ASD).
详细描述
To evaluate the safety and tolerability of low to moderate dose effects of Quillivant XR (liquid methylphenidate) and to observe changes in ADHD symptoms and functional outcomes in children with ASD and ADHD. The investigators propose to investigate the low to moderate dose range of methylphenidate compared with a very low dose with a gradual dose escalation schedule because children with ASD have been found to be more sensitive to the adverse effects of methylphenidate (especially in medium to high doses) than children without ASD.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of Autistic disorder or Asperger's disorder by DSM-IV or Autism Spectrum Disorder by DSM-V.
- •A DSM-V diagnosis of ADHD based upon the K-SADS-P.
- •Clinical Global Impressions - Severity for ADHD (CGI-S-ADHD) rating >
- •Findings on physical exam, labs and ECG are judged to be normal for age with pulse and blood pressure within 95% of age and gender mean.
- •Informed consent by a parent or legal guardian, and assent for children with developmental age 7 years or older.
- •At least one parent fluent in English
排除标准
- •History of Seizure disorder (Febrile seizures are non-exclusionary).
- •History of Intellectual Disability (IQ< 70)
- •Treatment with MAO Inhibitor (or within 14 days following discontinuation of MAO Inhibitor).
- •Other psychotropic medication other than stable dose of Selective Serotonin Reuptake Inhibitors, which is permitted)
- •Known to be hypersensitive to methylphenidate, or other components of Quillivant XR
- •Cardiac or other medical contraindications for stimulant trial (e.g., family history of heart attack at age younger than 40 years, personal history of heart disease, history of fainting while exercising, structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac problems. If any doubt, children will be referred to a cardiologist for a cardiac clearance.
- •Raynaud's disease
- •Pregnancy or Breast-feeding.
研究组 & 干预措施
Very Low Dose Quillivant XR
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.
干预措施: Very Low Dose Quillivant XR (Drug)
Low Dose Quillivant XR
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.
干预措施: Low Dose Quillivant XR (Drug)
Moderate dose Quillivant XR
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.
干预措施: Moderate Dose Quillivant XR (Drug)
结局指标
主要结局
ADHD Rating Scale - IV
时间窗: once a week for 6 weeks
Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.
次要结局
- Clinical Global Impressions-ADHD - Severity(once a week for 6 weeks)
- Clinical Global Impression - Improvement (CGI-I)(once a week for 6 weeks)
研究者
Mark Stein
Director of ADHD/Related Disorders Program
Seattle Children's Hospital