Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: A Randomized, Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Change in Children's Yale Brown-Obsessive Compulsive Scale for Autism Spectrum Disorder (CYBOCS-ASD) at 12 weeks
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. This is a 12-week double-blind, randomized, placebo-controlled trial of NAC.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The placebo compound will match the active N-acetylcysteine in appearance, odor, taste, and packaging.
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
- •diagnosis of autism spectrum disorder confirmed with the Autism Diagnostic Interview- Revised and the Autism Diagnostic Observation Schedule-2, Brief Observation of Symptoms of Autism, or Childhood Autism Rating Scale
- •at least moderate severity of restricted and repetitive behaviors defined by a Children's Yale-Brown Obsessive Compulsive Scale for Autism Spectrum Disorder score ≥ 11
- •physical development indicative of prepubescence as defined by criteria for Tanner Stage 1
- •if home address is within 300 miles of the primary study site, participants must pass MR safety screening (e.g., no metal in the body) and attempt baseline neuroimaging (MRI or EEG), otherwise baseline neuroimaging is not required for participation
- •have stable medication regimens (≥ 30 days) and psychosocial treatments (≥ 60 days) prior to randomization with no anticipated changes during the trial
排除标准
- •presence of known genetic abnormalities associated with ASD (e.g. Fragile X)
- •current or life-time diagnosis of severe psychiatric disorder (e.g., schizophrenia)
- •presence of significant medical problems
- •the inability of at least one caregiver to speak and read English to a sufficient level
- •participants taking glutathione agents/prodrugs
- •history of any adverse effects to glutathione agents/prodrugs
- •the inability to drink a sample study compound dissolved in liquid
研究组 & 干预措施
Placebo
12 week administration of matched placebo
干预措施: Placebo (Drug)
N-acetylcysteine
12 week administration of active study compound
干预措施: N acetyl cysteine (Drug)
结局指标
主要结局
Change in Children's Yale Brown-Obsessive Compulsive Scale for Autism Spectrum Disorder (CYBOCS-ASD) at 12 weeks
时间窗: Screening and week 12
Severity of restricted and repetitive behaviors, higher scores indicate more severe behaviors
Change in Glutamatergic neurometabolites at 12 weeks
时间窗: Baseline and week 12
Glu and Glx measured by magnetic resonance imaging
次要结局
- Change in Gamma band activity at 12 weeks(Baseline and week 12)
- Change in Restricted and Repetitive Behavior Scale Revised (RBS-R) at 12 weeks(Baseline and week 12)
研究者
John Patrick Hegarty
Clinical Assistant Professor
Stanford University