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

University of Cincinnati30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Attention Deficit Disorder

Interventions

DHA Omega-3DRUG

Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 10 weeks

PlaceboDRUG

corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)

Eligibility

Sex: ALLMin age: 5 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: 10 weeks

Data from ClinicalTrials.gov

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