E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ADHD (combined type) and co-morbidity in children |
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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 |
The objective of this study is to measure if supplementation with omega-3 fatty acids (mostly EPA) could improve symptoms in children with ADHD (combined type) and co-morbidity. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Informed Consent. 2. Age: 7 years, 0 months through 12 years (up to, but not including, the 13th birthday at the time of screening). 3. Diagnosis: Meets diagnostic criteria for Attention-Deficit Hyperactivity Disorder, combined subtype, together with any co-morbidity (except for exclusion criteria, see below). Diagnosis is made from the clinical impression of the physician taking into account the rating scales from parents and teachers, as well as evaluations made at the clinical unit. 4. Educational Status: Patient and family must be judged by the study team to be at an educational level sufficient to be able to follow the study protocol and adhere to its requirements. 5. Physical Status: No medical conditions requiring intervention based on screening interview with parent.
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E.4 | Principal exclusion criteria |
1. Mental retardation (IQ<70). 2. Diagnosis of autism according to DSM-IV. 3. Major depression according to DSM-IV. 4. Epileptic seizure (including Petit Mal) some time last two years. 5. Other neurological disorder. 6. Other endocrine disorders (i.e. diabetes mellitus, thyroid disorder, etc) 7. Other ongoing medication, i.e. psychopharmaca, anti-convulsants, stimulants. If a child has not responded to stimulants it could be included after a wash-out period of 2 weeks. If the child has taken PUFA a wash-out period of 10 weeks is required (based on the turnover period of 8 weeks). 8. Fish allergy
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E.5 End points |
E.5.1 | Primary end point(s) |
Significantly higher improvement in the score on the Conners’ rating scales (CPRS+CTRS) (last visit score minus baseline score) in the treatment group compared to the control group. |
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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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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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The last visit of the last subject undergoing the trial |
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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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |