Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: an Open Label Extension
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Change in restricted and repetitive behaviors as measured by Children's Yale Brown Obsessive Compulsive Scale - Autism Spectrum Disorder (CYBOCS-ASD)
研究概览
简要总结
The goal of this study is to target the neurobiology of restricted and repetitive behaviors in children with autism spectrum disorder using N-acetylcysteine (NAC), a well-tolerated nutritional supplement that has shown promise for reducing symptom severity in recent small-scale trials. The findings from this research will shed light on the mechanisms of action underlying the clinical benefits of NAC and the effects of NAC on altering restricted and repetitive behavior symptom severity in children with autism spectrum disorder.
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
- 3 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participation in an associated single-dose (IRB-54931, NCT04278898) or randomized, controlled trial of NAC (IRB- 68353, NCT05664789).
- •stable medication regimens (≥ 30 days) with no anticipated changes during the trial.
排除标准
- •the presence of significant medical problems that reduce medical stability.
研究组 & 干预措施
N-Acetylcysteine
干预措施: N-acetylcysteine (Drug)
结局指标
主要结局
Change in restricted and repetitive behaviors as measured by Children's Yale Brown Obsessive Compulsive Scale - Autism Spectrum Disorder (CYBOCS-ASD)
时间窗: Screening, Week 8, week 12
Higher scores on the Children's Yale Brown Obsessive Compulsive Scale - Autism Spectrum Disorder mean higher levels of restricted and repetitive behaviors (Raw Score Total Range: 0-20)
Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI)
时间窗: Baseline and Week 12 of treatment
次要结局
- Change in restricted repetitive behavior subtypes as measured by the Restricted Behavior Scale - Revised (RBS-R)(Baseline, week 8, week 12)
- Change in Gamma band amplitude and synchronization measured by electroencephalography (EEG)(Baseline, Week 12)
研究者
John Patrick Hegarty
Instructor
Stanford University