NCT01695200已完成4 期
The Role of Omega-3 Fatty Acids in the Management of Singaporean Children With Autism Spectrum Disorders
National Healthcare Group, Singapore2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment
研究概览
简要总结
This is a 12-week open label trial to evaluate whether omega-3 fatty acids is effective in reducing the severity of autism and its comorbidities.
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between ages 5 and 18 years old
- •Diagnosed to have Autism, Asperger Syndrome, or PDDNOS by the DSM-IV criteria; met the Autism or Spectrum classification for Autism Diagnostic Interview - Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS)
- •Written parental consent for participation
- •Those not on current standard-of-care treatments for ASD
排除标准
- •Below 5 and above 18 years old
- •No formal diagnosis of Autism, Asperger Syndrome or PDD-NOS
- •Without written parental consent for participation
- •Those with brain pathology such as serious head injury, epilepsy, etc.
- •Those on current standard-of-care treatment for ASD
- •Those with psychotic symptoms, self-injurious behaviours and/or suicidal tendency, and other history of clinically significant medical conditions screened by the attending doctor to have increase the risk associated with study participation
- •Those on other types of medication or supplements or with change in dose
结局指标
主要结局
Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment
时间窗: 12 weeks
次要结局
- Change from baseline in teacher rated Social Responsiveness Scale (SRS) scores during treatment(12 weeks)
- Children's Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders (CYBOCS-PDD)(12 weeks)
- Change from baseline in parent rated Child Behavior Checklist (CBCL) scores during treatment(12 weeks)
- Change from baseline in teacher rated Teacher Report (TRF) scores during treatment(12 weeks)
- Change from baseline in clinician rated Clinical Global Impression (Severity and Improvements) scores during treatment(12 weeks)
- Change from baseline in clinician rated Global Assessment of Functioning (GAF) scores during treatment(12 weeks)
研究者
Dr. Sung Min
Senior Consultant
National Healthcare Group, Singapore
研究点 (2)
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