Trial of Propranolol in Children and Youth With Autism Spectrum Disorder and Predictors of Response
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Change in General Social Outcomes Measure (GSOM) Assessment
研究概览
简要总结
The purpose of this study is to find out how the brain of people with autism is affected by Propranolol. Propranolol is not FDA approved for the treatment of autism. Propranolol is FDA approved for the treatment of heart conditions such as blood pressure
This research is being done because there are currently no drug treatment options for language impairments and social difficulties often experienced by people with autism.
详细描述
The specific aim of this study is to examine the effects of serial doses of propranolol on social interaction, and secondarily on language tasks, anxiety, adaptive behaviors, and global function in high functioning adults and adolescents with autism in a double-blinded, placebo-controlled trial. The investigators will also examine whether response to treatment can be predicted based upon markers of autonomic functioning, such as skin conductance, heart rate variability (HRV), and the pupillary light reflex (PLR), and whether anxiety can predict treatment response. The hypothesis is that social functioning and language abilities will benefit from serial doses of propranolol, and that those with the greatest degree of autonomic dysregulation, or the lowest functional connectivity, will demonstrate the greatest benefit from the drug.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 7 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Autism Spectrum Disorder diagnosis
- •intelligence quotient (IQ) >= 85 (if aged 15-24), >= 75 (if aged 7-14)
- •Native English speaker
- •Parent or caregiver must older than 18 years and be a native English speaker
排除标准
- •Taking Alpha 2 agonists
- •Non-autism learning disorder
- •Other major psychiatric disorders
- •Other neurological disorders
- •Major head trauma
- •Reaction to adhesives
- •Reactive airway disease
- •Thyroid disease
- •Bradyarrhythmias
- •Unexplained syncope
- •Pregnancy
- •Possible interacting drugs
- •Underweight (<20kg if aged 7-14 years)
- •Factors affecting ability to have an MRI (if aged 15-24 years)
研究组 & 干预措施
Propanolol and MRI
Participants will receive propranolol via oral capsule, crushed tablet, or liquid daily. The drug dosage will be titrated slowly to ensure the drug is tolerated well. Those aged 15-24 will have an MRI before starting drug.
干预措施: Propranolol (Drug)
Propanolol and MRI
Participants will receive propranolol via oral capsule, crushed tablet, or liquid daily. The drug dosage will be titrated slowly to ensure the drug is tolerated well. Those aged 15-24 will have an MRI before starting drug.
干预措施: Magnetic Resonance Imaging (MRI) (Device)
Placebo and MRI
Participants will receive placebo via oral capsule, crushed tablet, or liquid daily. Those aged 15-24 will have an MRI before starting drug.
干预措施: Placebo (Drug)
Placebo and MRI
Participants will receive placebo via oral capsule, crushed tablet, or liquid daily. Those aged 15-24 will have an MRI before starting drug.
干预措施: Magnetic Resonance Imaging (MRI) (Device)
结局指标
主要结局
Change in General Social Outcomes Measure (GSOM) Assessment
时间窗: Day 1, 6 weeks, 12 weeks
次要结局
- Change in Clinical Evaluation of Language Fundamentals (CELF-5) assessment(Day 1, 6 weeks, 12 weeks)
- Change in Vineland Adaptive Behavior Scales (VABS-2) assessment(Day 1, 6 weeks, 12 weeks)
- Change in score on Anagrams test(Day 1, 6 weeks, 12 weeks)
- Change in Social Responsiveness Scale (SRS-2)(Day 1, 6 weeks, 12 weeks)
- Change in Semantic fluency test results(Day 1, 6 weeks, 12 weeks)
- Change Clinical Global Impression surveys(Day 1, 6 weeks, 12 weeks)
- Change in Autism Impact Measure (AIM)(Day 1, 6 weeks, 12 weeks)
- Change in score on Aberrant Behavior Checklist (ABC)(Day 1, 6 weeks, 12 weeks)
- Change in gastrointestinal symptomology(Day 1, 1 week, 2 weeks, 6 weeks, 12 weeks)
研究者
David Beversdorf
Professor, Department of Radiology & Thompson Center for Autism & Neurodevelopmental Disorders
University of Missouri-Columbia