Omega-3 Polyunsaturated Fatty Acids in Youth With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03542643
• Other study ID #: CMUH104-REC2-058
• Status: Completed
• Phase: N/A
• Start date: July 7, 2016
• Est. completion date: December 11, 2017

Study information

• Verified date: June 2018
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 11, 2017
• Est. primary completion date: December 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Dietary Supplement:
• n-3 Polyunsaturated fatty acid
1g of Eicosapentaenoic acid (EPA)
• Placebo
Olive oil ethyl esters

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung

Sponsors (3)

Lead Sponsor	Collaborator
China Medical University Hospital	King's College London, National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Blood PUFAs levels at 12 Weeks	measurement of blood PUFAs levels	Week 0 and Week 12
Other	Changes in Blood Inflammatory Markers at 12 Weeks	measurements of blood inflammatory markers	Week 0 and Week 12
Other	Changes in Salivary Cortisol at 12 Weeks	measurements of salivary cortisol	Week 0 and Week 12
Primary	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	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