A Single Centre, Open-Label, Randomised Multi-Dose Study to Assess Changes in the Brain Metabolism of Juvenile ADHD Patients After Thirteen Weeks of Daily Intake of 4 g Superba Krill Oil or 4 g omega-3 Enriched Fish Oil

• Conditions: Attention deficit/hyperactivity disorder; MedDRA version: 12.1Level: LLTClassification code 10003736Term: Attention deficit/hyperactivity disorder

• Registration Number: EUCTR2010-019635-36-IS
• Lead Sponsor: Aker BioMarine Antarctic AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

All participants are male ADHD patients of the combined type and are of age 7-11 years.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Known allergy to crustacean or fish

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate changes in the brain metabolism of juvenile ADHD patients after thirteen weeks of daily doses of 4 g Superba krill oil or 4 g omega-3 enriched fish oil;Primary end point(s): EEG measurements from 40 ADHD patients before and after 13 weeks of treatment with food supplements rich of omega-3 fatty acids.;Secondary Objective: To evaluate if there are changes in the brain metabolism of those who receive Superba krill oil which can be related to a decrease in ADHD symptoms as measured by EEG and/or a clinical assessment.<br><br>To evaluate if there are changes in the brain metabolism of those who receive Superba krill oil which can be related to a larger decrease in ADHD symptoms as measured by EEG and/or a clinical assessment when compared to those who take in the fish oil.