Omega- 3 Fatty Acids, Neuroendocrine and Attention Deficit Hyperactivity Disorder With (OMNeADHD) A Double Blind Randomized Controlled Trial of High Dose Omega- 3 Fatty Acids in Children and Adolescents With ADHD With Omega- 3 Deficiency.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical symptoms-attention and impulsivity symptom severity
研究概览
简要总结
This is a 12 week randomized controlled study on the effects of omega-3 fatty acids in youth with attention deficit hyperactivity disorder (ADHD) with omega-3 deficiency.
详细描述
This is a 12 week randomized controlled study on the effects of omega-3 fatty acids (EPA or DHA) in youth with attention deficit hyperactivity disorder (ADHD) with omega-3 deficiency.
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
double blind
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
- •DSM-5 diagnosis of ADHD
- •Did not have any changes of ADHD treatment (pharmacological/psychological) within 4 weeks of entering the trial.
- •SNAP-IV inattention subscale >=12, or hyperactivity subscale >=12, or inattention+ hyperactivity subscales >=24
排除标准
- •Allergic to omega-3
- •Physical disorders: thyroid function, cancer
- •Psychiatric comorbidity: SUD, psychotic disorders, bipolar disorder, major depressive disorder
研究组 & 干预措施
omega-3 fatty acids: EPA
EPA
干预措施: Omega-3 (Dietary Supplement)
omega-3 fatty acids: DHA
DHA
干预措施: Omega-3 (Dietary Supplement)
placebo
olive oil
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Clinical symptoms-attention and impulsivity symptom severity
时间窗: week 0,1,2,4,8,12
The Swanson, Nolan, and Pelham Rating Scale- 4th edition (SNAP-IV) is used to help assess symptoms of ADHD (Attention Deficit Hyperactivity Disorder) in children and adolescents. It consists of a series of questions that rate the severity of behaviors such as inattention, hyperactivity, and impulsivity, based on teacher and parent observations. The scale includes both parent and teacher versions, allowing for a comprehensive view of a child's behavior in different environments. The scoring system rates each behavior on a 4-point scale from 0 (never or rarely) to 3 (very often), and higher total scores indicate more significant ADHD symptoms. The results help clinicians in diagnosing ADHD and monitoring treatment progress.
次要结局
- Measurement of cognitive function: attention and impulsivity(week 0,12)
- Concentration of Peripheral cortisol levels(week 0,12)
研究者
Pei-Chen Chang
Director of Child Psychiatry Division
China Medical University Hospital