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Completed

NCT Number: NCT01883817

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

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

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Key information

Conditions

Attention Deficit Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, 45219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DHA Omega-3

Drug

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

Other names: Docosahexaenoic acid, Omega 3 Fatty Acids

Placebo

Drug

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

Other names: Inactive drug

Primary outcomes

  1. Attention-Deficit Hyperactivity Disorder Symptom Ratings Using the ADHD Rating Scale (ADHD-RS-IV)

    Time frame: 10 weeks

    Attention-Deficit Hyperactivity Disorder Rating Scale Version IV (ADHD-RS-IV) Min score: 0 Max score: 54 Higher score = more severe ADHD symptoms

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • dsm-firmenich Switzerland AG

Registry information

Official study title

Docosahexaenoic Acid Augmentation of Cortical Attention Networks in ADHD

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jun 21, 2013
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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