Omega-3 Polyunsaturated Fatty Acids in Youth With ADHD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Double-blind Randomised Controlled Trial of N-3 PUFAs in Children With Attention Deficit Hyperactivity Disorder

Conditions
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Attention Deficit Hyperactivity Disorder, ADHD

Intervention / Treatment
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* Dietary Supplement: n-3 Polyunsaturated fatty acid
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: N-3 polyunsaturated fatty acids<br>n-3 polyunsaturated fatty acids dosage of 1g of Eicosapentaenoic acid(EPA) | Dietary Supplement: n-3 Polyunsaturated fatty acid<br>* 1g of Eicosapentaenoic acid (EPA)<br>|
| Placebo Comparator: Placebo<br>olive oil ethyl esters | Dietary Supplement: Placebo<br>* Olive oil ethyl esters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Continuous Performance Test Raw Scores at 12 weeks | 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. | Week 0 and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in SNAP-IV Scores for Inattention, Hyperactivity and Total ADHD Symptom Severity | Inattention: items 1-9 Hyperactivity: items 10-18 Total ADHD: items 1-18 the greater the scores on SNAP-IV indicate the greater the severity of ADHD symptoms | Week 0, 2,4,8,12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, n-3 polyunsaturated fatty acids, children, adolescents