Omega-3 Fatty Acids Supplementation in ADHD

Study Overview
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Brief Summary
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The overarching aim of the proposed study is to assess whether omega-3 fatty acids supplementation can augment the effects of methylphenidate in children with ADHD. The investigators hypothesized that omega-3 fatty acids supplementation will be associated with improved ADHD symptoms.

Official Title
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Augmenting the Effects of Methylphenidate: A Randomized, Placebo-Controlled Trial of Omega-3 Fatty Acids Supplementation in Children With Attention Deficit Hyperactivity Disorder

Conditions
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ADHD

Intervention / Treatment
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* Dietary Supplement: Omega-3 Fatty Acids Supplementation
* Dietary Supplement: Omega-3 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants between ages 6 and 12 years who: have been clinically diagnosed with ADHD by a physician meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992) are willing to participate in a randomized, double-blind, placebo-controlled trial, complete with written, informed parental consent, are on stable dosage of methylphenidate treatment before the start of the study are able to speak English or German Exclusion Criteria: Participants who are younger than 6 years old or older than 12 years old Those who have not been clinically diagnosed with ADHD by a physician Those who did not meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992) Those without written parental consent Those with brain pathology such as serious head injury, epilepsy, and intellectual disability (IQ < 70) Those with titrated dosage of methylphenidate before the start of the study Those on neurofeedback training, and/or psychosocial intervention addressing attention problems Those with known hypersensitivity to the IMP under investigation Those who are unable to read and understand the parent/participant information Those receiving medications other than methylphenidate

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3 Fatty Acids<br>1g of Omega-3 per day [400mg DHA & 600mg EPA] for 12 weeks: 2 capsules after breakfast and 2 capsules after dinner | Dietary Supplement: Omega-3 Fatty Acids Supplementation<br> <br> |
| Placebo Comparator: Omega-3 Placebo<br>1g of Omega-3 Placebo per day for 12 weeks: 2 capsules after breakfast and 2 capsules after dinner | Dietary Supplement: Omega-3 Placebo<br>* Placebo capsules manufactured to mimic Omega-3 capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ADHD Rating Scale-IV total score |  | Baseline, Week 6, and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Child Behaviour Checklist total score |  | Baseline and Week 12 |