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

University of Cincinnati

Status and phase

Completed

Phase 3

Conditions

Attention Deficit Disorder

Treatments

Drug: Placebo

Drug: DHA Omega-3

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01883817

2013-0199

Details and patient eligibility

About

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

Full description

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.

Enrollment

30 patients

Sex

All

Ages

5 to 15 years old

Volunteers

No Healthy Volunteers

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