Clinical trial NCT03542643: Omega-3 Polyunsaturated Fatty Acids in Youth With ADHD
Official title: A Double-blind Randomised Controlled Trial of N-3 PUFAs in Children With Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
ADHD
Keywords: ADHD
n-3 polyunsaturated fatty acids
children
adolescents
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
name: King's College London
First posted: 2018-05-31
Enrollment: 105
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Continuous Performance Test Raw Scores at 12 weeks
timeFrame: Week 0 and Week 12
Secondary outcomes:
measure: Changes in SNAP-IV Scores for Inattention, Hyperactivity and Total ADHD Symptom Severity
timeFrame: Week 0, 2,4,8,12
Other outcomes:
measure: Changes in Blood PUFAs levels at 12 Weeks
timeFrame: Week 0 and Week 12
measure: Changes in Blood Inflammatory Markers at 12 Weeks
timeFrame: Week 0 and Week 12
measure: Changes in Salivary Cortisol at 12 Weeks
timeFrame: Week 0 and Week 12
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
References: