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NCT Number: NCT03542643

Omega-3 Polyunsaturated Fatty Acids in Youth With ADHD

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Taichung, 404, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

n-3 Polyunsaturated fatty acid

Dietary Supplement

1g of Eicosapentaenoic acid (EPA)

Placebo

Dietary Supplement

Olive oil ethyl esters

Primary outcomes

  1. Changes in Continuous Performance Test Raw Scores at 12 weeks

    Time frame: 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.

Secondary outcomes

  1. Changes in SNAP-IV Scores for Inattention, Hyperactivity and Total ADHD Symptom Severity

    Time frame: Week 0, 2,4,8,12

    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

Other outcomes

  1. Changes in Blood PUFAs levels at 12 Weeks

    Time frame: Week 0 and Week 12

    measurement of blood PUFAs levels

  2. Changes in Blood Inflammatory Markers at 12 Weeks

    Time frame: Week 0 and Week 12

    measurements of blood inflammatory markers

  3. Changes in Salivary Cortisol at 12 Weeks

    Time frame: Week 0 and Week 12

    measurements of salivary cortisol

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Collaborators

  • King's College London
  • National Science and Technology Council, Taiwan

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 31, 2018
Registry last updated
Jun 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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