Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
| King's College London | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-3 polyunsaturated fatty acids | Active Comparator | n-3 polyunsaturated fatty acids dosage of 1g of Eicosapentaenoic acid(EPA) |
|
| Placebo | Placebo Comparator | olive oil ethyl esters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| n-3 Polyunsaturated fatty acid | Dietary Supplement | 1g of Eicosapentaenoic acid (EPA) |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University | Taichung | 404 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37058600 | Derived | Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | Olive oil ethyl esters |
|
| Week 0 and Week 12 |
| Changes in Salivary Cortisol at 12 Weeks | measurements of salivary cortisol | Week 0 and Week 12 |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |