NCT01315327已完成不适用
A Double-Blind, Placebo-Controlled Study of Omega-3 Fatty Acids in Children and Adolescents With Tourette's Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Yale Global Tic Severity Scale (YGTSS)
研究概览
简要总结
This study examines the safety and efficacy of omega-3 fatty acids (fish oil) for the treatment of Tourette's Disorder.
详细描述
This is a 20-week, double-blind, placebo (olive oil) controlled study examining supplemental fish oil in the treatment of tic and OCD symptoms.
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)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 6 through 18 inclusive
- •Meet full DSM-IV diagnostic criteria for TD or chronic motor tic disorder
- •Normal laboratory results, including serum chemistries, hematology, and urinalysis
- •Must be able to swallow capsules.
- •Must be of normal intelligence in the judgment of the investigator.
- •Subjects and parents must possess an educational level, degree of understanding and command of the English language to enable them to communicate suitably with the investigator and study coordinator and to understand the nature of the study.
- •Subjects and their legal representatives must be considered reliable.
排除标准
- •Organic brain disease, for example, traumatic brain injury residua
- •Meeting criteria for mental retardation as defined by the DSM-IV.
- •A history of seizure disorder (other than febrile seizure).
- •A Subjects with history of Sydenham's Chorea.
- •Autism, schizophrenia or other psychotic disorders.
- •A primary diagnosis of a major mood disorder that requires ongoing psychiatric treatment.
- •A neurological disorder other than a tic disorder.
- •A documented auto-immune disorder.
- •A major medical illness.
- •A history of ongoing or previously undisclosed child abuse (risk of removal from home would not allow for consistent caretaker ratings).
- •Subjects who, in the opinion of the investigator, are unsuitable in any other way to participate in this study.
研究组 & 干预措施
Omega-3 Fatty Acids
Experimental
Omega-3 Fatty Acids (fish oil), flexibly titrated up to 6000 mg/day.
干预措施: Omega-3 Fatty Acids (Drug)
Placebo
Placebo Comparator
Olive oil placebo, looks and tastes identical to active intervention.
干预措施: Olive oil (Drug)
结局指标
主要结局
Yale Global Tic Severity Scale (YGTSS)
时间窗: Baseline and then weekly for 20 weeks
This assessment captures tic type and frequency as well as intensity and complexity, and impairment due to tics.
次要结局
- Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)(Baseline and then weekly for 20 weeks)
研究者
研究点 (1)
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