E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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.
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
ADHD symptoms are often carried through to the adolescent period and long-term intervention is often needed. Patients and their parents often choose alternative treatments for ADHD. Omega-3 fatty acids supplementation is one popular alternative treatment, and relatively safe, but the effectiveness has not been assessed enough . This study aims to evaluate whether EFA supplementation improves ADHD symptoms in ADHD male adolescents.
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E.2.2 | Secondary objectives of the trial |
In addition, these secondary questions are to be assessed:
Does a fatty acids deficiency symptoms score correlate with blood phospholipid levels of essential fatty acids and the symptoms of hyperactivity disorder?
Is there any relationship between electroencephalography, ADHD symptoms and fatty acids status?
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
•Omega-3 fatty acids supplementation improves Conners’ teacher rating scale ADHD global score in ADHD male adolescents. •Omega-3 fatty acids supplementation improves Conners’ parent rating scale ADHD global score in ADHD male adolescents. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Intervention period is for 3 months. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |