A Double-blind Randomised Controlled Trial of N-3 PUFAs in Children With Attention Deficit Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Changes in Continuous Performance Test Raw Scores at 12 weeks
研究概览
简要总结
N-3 polyunsaturated fatty acids(N-3 PUFAs) is important in balancing the immune function and crucial for the developing brain. Deficiency in n-3 PUFAs might be linked to the poor cognitive performances resulting in inattention and hyperactivity in youth with attention deficit hyperactivity disorder (ADHD). N-3 PUFAs appears to be a promising treatment that is safe, beneficial to youth with ADHD. In this proposal, investigators aim the test the hypothesis that n-3 polyunsaturated fatty acids will be more effective than placebo in improving cognitive function in youth with ADHD after 12 weeks of intervention.
详细描述
This is a 1-year study and a randomized, double-blind, and placebo controlled Clinical the study. investigators plan to enrol 100 subjects from Child and Adolescent Psychiatry Outpatient Clinic of China Medical University Hospital.Participants will be randomized into omega-3 polyunsaturated fatty acids or placebo group.The intervention period is 12 weeks. Evaluation of the cognitive function ( using Continuous Performance Test 3rd Edition ) of the subjects who are enrolled into the study will take place at baseline and after the 12th week. The symptom severity of ADHD will be measured with Swanson, Nolan, Pelham Questionnaire (SNAP-IV) at baseline, 2,4,8, and 12 weeks. The plasma level of n-3 polyunsaturated fatty acids, blood and salivary inflammatory markers will also be measured at the beginning and at the end of the study.
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
- •DSM-5 diagnosed ADHD
- •Age 6-18 years old at time of enrolment
- •Conner's rating scares (CPRS) with scores >= 2 standard deviations
- •drug native or no medication use for past 6 months
- •Signed informed consent
排除标准
- •Intelligence quotient <70
- •Comorbid other psychiatric disorders, such as autism spectrum disorders, anxiety disorders, conduct disorders, schizophrenia, major depressive disorders and bipolar spectrum disorders
- •Comorbid physical disorders, such as thyroid dysfunction, cerebral palsy
- •Current using omega-3 supplements
- •Allergy to omega-3
研究组 & 干预措施
N-3 polyunsaturated fatty acids
n-3 polyunsaturated fatty acids dosage of 1g of Eicosapentaenoic acid(EPA)
干预措施: n-3 Polyunsaturated fatty acid (Dietary Supplement)
Placebo
olive oil ethyl esters
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in Continuous Performance Test Raw Scores at 12 weeks
时间窗: Week 0 and Week 12
Correct Detection: This indicates the number of times the client responded to the target stimulus. Higher rates of correct detections indicate better attentional capacity. Reaction times: This measures the amount of time between the presentation of the stimulus and the client's response. Omission errors: This indicates the number of times the target was presented, but the client did not respond/click the mouse. High omission rates indicate that the subject is either not paying attention (distractibility) to stimuli or has a sluggish response. Commission errors: This score indicates the number of times the client responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. A slow reaction time with high commission and omission errors, indicates inattention in general.
次要结局
- Changes in SNAP-IV Scores for Inattention, Hyperactivity and Total ADHD Symptom Severity(Week 0, 2,4,8,12)