NCT04278898招募中2 期
Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: a Single-dose Challenge Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI)
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children between 3 years and 12 years 11 months at the time of consent
- •diagnosis of Autism Spectrum Disorder confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-2 (ADOS-2), or Brief Observation of Symptoms of Autism (BOSA), or Childhood Autism Rating Scale- Second Edition (CARS-2).
- •at least moderate Restricted and Repetitive Behaviors severity defined by a Children's Yale-Brown Obsessive Compulsive Scale for children with autism spectrum disorder score ≥ 11,
- •physical development indicative of prepubescence as defined by the criteria for Tanner Stage 1,
- •medically stable,
- •passes MR safety screening (e.g., no metal in the body).
排除标准
- •presence of known genetic abnormalities associated with Autism Spectrum Disorder (e.g. Fragile X),
- •current or life-time diagnosis of severe psychiatric disorder (e.g., schizophrenia),
- •presence of significant medical problems that would interfere with participation,
- •the inability of at least one caregiver to speak/read English to a sufficient level to complete study requirements and materials,
- •individuals taking antioxidant agents and glutathione prodrugs, or
- •the inability/unwillingness to swallow an agent during the screening visit.
研究组 & 干预措施
N-acetylcysteine then Placebo
Experimental
干预措施: N-Acetylcysteine (Drug)
Placebo then N-acetylcysteine
Experimental
干预措施: N-Acetylcysteine (Drug)
结局指标
主要结局
Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI)
时间窗: 1 hour after single dose
次要结局
- Change in Gamma band amplitude and synchronization measured by electroencephalography(1 hour after single dose)
研究者
John Patrick Hegarty
Instructor
Stanford University
研究点 (2)
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