Effect of Omega-3 Fatty Acid on Cortical Function in ADHD

Study Overview
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Brief Summary
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The study hypothesis is that DHA is more effective than placebo in increasing brain activation and reducing symptoms in psychostimulant-free children with ADHD.

Detailed Description
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This study aims to determine the effects of 10-week dietary supplementation with the long-chain omega-3 fatty acid docosahexaenoic acid (DHA) or placebo on prefrontal cortical structural and functional connectivity using several neuroimaging techniques: DTI (Diffusion Tensor Imaging), 1H MRS(Proton Magnetic Resonance Spectroscopy), and fMRI (Functional Magnetic Resonance Imaging) in psychostimulant-free children with attention deficit hyperactivity disorder (ADHD). It is postulated that DHA supplements will increase brain activation and reduce ADHD symptomatology.

Official Title
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Docosahexaenoic Acid Augmentation of Cortical Attention Networks in ADHD

Conditions
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Attention Deficit Disorder

Intervention / Treatment
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* Drug: DHA Omega-3
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of written informed consent/assent Ages 5-15 years old Meets DSM-IV-TR criteria for ADHD as determined by the KSADS Exclusion Criteria: Contraindication to an MRI scan (i.e., braces, claustrophobia) A history of a major medical (e.g., diabetes) or neurological illness (e.g., epilepsy) Greater than 1 year outside appropriate age/grade level A history of intolerance or hypersensitivity to omega-3 fatty acids Currently taking omega-3 supplements Not proficient in English language Any history of a hematological disorder or concomitant use of anticoagulant medications Personal history of an Axis I psychiatric disorder other than ADHD Inability to swallow capsules

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 10 weeks | Drug: Placebo<br>* corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)<br>* Other names: Inactive drug;|
| Experimental: DHA Omega-3<br>Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 10 weeks | Drug: DHA Omega-3<br>* Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 10 weeks<br>* Other names: Omega 3 Fatty Acids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attention-Deficit Hyperactivity Disorder Symptom Ratings Using the ADHD Rating Scale (ADHD-RS-IV) | Attention-Deficit Hyperactivity Disorder Rating Scale Version IV (ADHD-RS-IV) Min score: 0 Max score: 54 Higher score = more severe ADHD symptoms | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD