Omega-3 Polyunsaturated Fatty Acids in Youth With ADHD

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

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.

Study Overview

• Status: Completed
• Conditions: ADHD; Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Dietary supplement: n-3 Polyunsaturated fatty acid; Dietary supplement: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: N-3 polyunsaturated fatty acids; n-3 polyunsaturated fatty acids dosage of 1g of Eicosapentaenoic acid(EPA)	Dietary supplement: n-3 Polyunsaturated fatty acid; 1g of Eicosapentaenoic acid (EPA)
PLACEBO_COMPARATOR: Placebo; olive oil ethyl esters	Dietary supplement: Placebo; Olive oil ethyl esters

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Blood PUFAs levels at 12 Weeks	measurement of blood PUFAs levels	Week 0 and Week 12
Changes in Blood Inflammatory Markers at 12 Weeks	measurements of blood inflammatory markers	Week 0 and Week 12
Changes in Salivary Cortisol at 12 Weeks	measurements of salivary cortisol	Week 0 and Week 12

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Collaborators: King's College London; National Science Council, Taiwan

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 7, 2016
• Primary Completion (ACTUAL): December 11, 2017
• Study Completion (ACTUAL): December 11, 2017

Study Registration Dates

• First Submitted: May 20, 2018
• First Submitted That Met QC Criteria: May 20, 2018
• First Posted (ACTUAL): May 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 15, 2018
• Last Update Submitted That Met QC Criteria: June 13, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: ADHD; children; n-3 polyunsaturated fatty acids; adolescents
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: CMUH104-REC2-058

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No