Omega-3 Fatty Acids Supplementation for Adolescent Boys with Attention Deficit Hyperactivity Disorder : a double-blind, randomized controlled trial - MAAFA

Phase 1

Conditions: Attention deficit / hyperactivity disorder (ADHD) is defined by DSM-IV criteria, which shows inattention, hyperactivity and impulsivity.ADHD is one of the most common child psychiatric disorders, more likely to be seen in males, and the prevalence is estimated approximately 5% in the UK (NICE ADHD guideline).ADHD is often prominent in early childhood and persist through adolescence to adulthood.

Registration Number: EUCTR2005-005330-12-GB

Lead Sponsor: King's College London (IOP)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 60

Inclusion Criteria

Male adolescents aged 12-17 with
1)Both Conners’ Parents ADHD Rating Global Score and Conners' Teachers Rating Global Score are above 65

2)Meet ADHD criteria using a semi-structured interview (CHIPS; Weller, 2000) based on DSM-IV criteria.

All subjects will score higher than 70 on the prorated IQ as measured by The Kaufman Brief Intelligence Test (K-BIT) (Chin, 2001).

Only right handed males will be tested EEG

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

1) Subjects who took omega-3 supplement within 6 months
2) A personal history of diabetes or other metabolic disorder influencing fatty acid metabolism
3) Subjects whose IQ is less than 70
4) Subjects who are not living in a family home or residential school
5) Subjects who are not in school during the intervention
6) Subjects who are non-English speakers
7) Serious or chronic disease
8) Low blood coagulation function (e.g. haemophilia, hepatic dysfunction, low-vitamin K)
9) Under these Medication: alpha tocopherol, selected anticoagulants (aspirin, warfarin, heparin), cyclosporine, clopidogrel, etretinate and topical steroids, cholesterol-lowering medications (atorvastatin, lovastatin, and simvastatin), non-steroidal anti-inflammatory
drugs (NSAIDs), dalteparin, dipyrdamole, enoxaparin, ticlopedine, other nutritional supplements.
10) Known allergy for fish product derivatives, Vitamin E derivatives, gelatine, olive oil
11) Pancreatic insufficiency
12) abnormal blood data: Triglyceride
For the EEG studies only, subjects with left handed, neurological problems or substance abuse will be excluded.