Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change From Baseline in Social Responsiveness Scale (SRS) Total Raw Score
研究概览
简要总结
The primary aim of this study is to examine the efficacy and tolerability of short-term omega-3 fatty acids monotherapy in youth with Autism Spectrum Disorders (ASD). The investigators hypothesize that Omega-3 fatty acids will be efficacious in improving the core and associated features of ASD in youth, and that Omega-3 fatty acids monotherapy will be safe and well tolerated by youth with ASD. The secondary aim of this study is to examine the neuropsychological effect of Omega-3 fatty acids monotherapy in youth with ASD. The investigators hypothesize that omega-3 fatty acids will be efficacious in improving cognitive functions in youth with 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Omega-3 Fatty Acid Treatment
干预措施: Omega-3 Fatty Acid (Drug)
Placebo (Sugar Pill)
干预措施: Omega-3 Fatty Acid (Drug)
结局指标
主要结局
Change From Baseline in Social Responsiveness Scale (SRS) Total Raw Score
时间窗: Pre-treatment - 12 weeks
The SRS is a 65-item rating scale completed by the participants parent or guardian. The scale measures the severity of autism spectrum symptoms as the occur in natural social settings. The total raw score is calculated by summing the 65 items. Total scores range from 0 to 195, where higher scores indicate greater severity. The outcome reported reflects the change from baseline (pre-treatment) in SRS Total raw score. When examining change from baseline, negative scores represent improvement (i.e., decrease in severity from baseline).
次要结局
- Change in NIMH Clinical Global Impression Scale for Pervasive Developmental Disorders (CGI-PDD) Improvement Scores(Pre-treatment - 12 weeks)
研究者
Gagan Joshi
Clinical Investigator, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD
Massachusetts General Hospital