ADHD (combined type) and co-morbidity in children
Conditions
Interventions
Product Name: PlusEPA
Product Code: NA
Pharmaceutical Form: Capsule, hard
Other descriptive name: Omega-3-acid ethyl esters
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Hela Pharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: ;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. | — |
Countries
Sweden
Outcome results
None listed