ADHD, Attention Deficit Hyperactivity Disorder
Conditions
Keywords
ADHD, n-3 polyunsaturated fatty acids, children, adolescents
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTn-3 Polyunsaturated fatty acid
1g of Eicosapentaenoic acid (EPA)
DIETARY_SUPPLEMENTPlacebo
Olive oil ethyl esters
Sponsors
National Science and Technology Council, Taiwan
King's College London
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Continuous Performance Test Raw Scores at 12 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in SNAP-IV Scores for Inattention, Hyperactivity and Total ADHD Symptom Severity | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in Blood PUFAs levels at 12 Weeks | Week 0 and Week 12 | measurement of blood PUFAs levels |
| Changes in Blood Inflammatory Markers at 12 Weeks | Week 0 and Week 12 | measurements of blood inflammatory markers |
| Changes in Salivary Cortisol at 12 Weeks | Week 0 and Week 12 | measurements of salivary cortisol |
Countries
Taiwan
Outcome results
None listed