Efficacy of Phosphatidylserine Enriched With n-3 PUFA Supplementation on ADHD in Children With Epilepsy
- Conditions
- EpilepsyADHD Inattention or Mixed TypeChildAttention Deficit Disorder With Hyperactivity
- Interventions
- Drug: Vayarin®, supplementation of n-3 PUFADrug: PLACEBO
- Registration Number
- NCT02348073
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
Our project aims to develop a new therapeutic approach in epilepsy-associated attention disorders in children, through evaluation of the clinical impact of dietary n-3 fatty acids, containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) conjugated to a phospholipid vector. The primary objective is to evaluate the efficacy of a PUFA supplementation (PS-Omega 3), after 12 weeks of treatment, on attention disorders in children with epilepsy. Secondary objectives include:
* To evaluate the impact of a supplementation of PS-Omega 3 on quality of life.
* To evaluate the impact of a supplementation of PS-Omega 3 on serum and erythrocyte lipid profiles.
* To assess the tolerance of a supplementation of PS-Omega 3.
* To assess the impact of a supplementation of PS-Omega 3 on the frequency of seizures.
* To describe the impact of a supplementation of PS-Omega 3, at 24 weeks,
1. on attention disorders in children with epilepsy,
2. on quality of life,
3. and on serum and erythrocyte lipid profiles. This study will recruit 272 subjects aged 6- 16 years, suffering from epilepsy (any type) and attention deficit hyperactivity disorder (ADHD) (inattentive or combined type) according to DSM V criteria in 12 clinical sites in France.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
- Children aged 6 to 15 years and 11 months.
- Children of either sex (male/female) suffering from epilepsy regardless of syndrome classification.
- Subjects on a stable dose of antiepileptic drugs (AED) for at least one month prior to inclusion and subjects for whom no change is considered a priori for the three months following the inclusion.
- Diagnosis of ADHD inattention or mixed type according to the DSM V criteria.
- Subjects must agree to study participation and their parents/legal guardian must provide written inform consent prior to participation in the study.
- Subjects less than 6 years or older than 16 years old
- AED not stable for at least one month and/or a change in AED is expected in the three months following inclusion.
- Diagnosis of ADHD hyperactivity type exclusive according to DSM V criteria.
- Mental retardation defined by a score < 70 on the verbal comprehension and perceptual reasoning Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV), performed within 18 months prior to inclusion or at V1.
- Diagnosis of a psychiatric comorbidity other than ADHD according to the DSM V criteria, including: pervasive developmental disorders including autism disorders; bipolar disordersand psychotic disorders.
- Children suffering from diabetes, any type.
- Use of psychoactive drugs in ADHD within the previous month: Methylphenidate, Amphetamine, Atomoxetine, Modafinil and Antidepressants whatever the class.
- Use of dietary supplementation, other than vitamins, within the last 3 months.
- Use of ketogenic diet within the last 3 months.
- Allergy to fish or other sea products.
- Soy allergy.
- Absence of coverage by social security.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PS-OMEGA 3, capsules twice daily Vayarin®, supplementation of n-3 PUFA Vayarin®, supplementation of n-3 PUFA: each capsule contains 8.5 mg of docosahexaenoic acid (DHA), 21.5 mg of eicosapentaenoic acid (EPA) and 75 mg of phosphatidylserine. PLACEBO, capsules twice daily PLACEBO The placebo will be made of cellulose and a small amount of fish powder to maintain the double-blind in odor and taste. The supplementation in n-3 PUFA in the placebo group may be considered as negligible. Placebo will be administered as indistinguishable capsules, identical to the active product.
- Primary Outcome Measures
Name Time Method Reduction of the ADHD-rating scale IV inattentive subscore in subjects assigned to supplementation of PS-Omega 3 in comparison with the placebo group after 12 weeks of treatment. 12 weeks The ADHD Rating Scale-IV quantifies each of the 18 symptoms of ADHD on a 0 to 3 scale, with a maximum score of 54 points. Nine of the 18 items score for inattention while the nine others assess hyperactivity with a maximum of 27 points each. The discriminative value of these two subscales was validated, allowing their individual use.
- Secondary Outcome Measures
Name Time Method Evolution of eythrocytes lipid profiles in subjects assigned to supplementation of PS-Omega 3 in comparison with the placebo group after 12 weeks of treatment. 12 weeks Quantification of, in erythrocyte membrane, before and after 12 weeks of treatment: total lipid mass ; total phospholipids ; individual phospholipids including: lysophosphatidylcholin, phosphatidylcholin, sphingomyelin, phosphatidylserine, phosphatidylinositol, phosphatidylethanolamine, diphosphatidylglycerol, lysophosphatidylethanolamine ; total triglycerides ; fatty acids profiles in phospholipids; fatty acids profiles in triglycerides ; fatty acids profiles in cholesterol esters.
Number of subjects with a reduction in the frequency of seizures ≥ 50%, in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment. 12 weeks After 24 weeks of treatment, change in quality of life score (EFIQUACEE questionnaire). 24 weeks Reduction of TOVA total score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment. 12 weeks The TOVA (Test of Variables of Attention) is a computerized tool assessing the capacity of attention and impulse control. This test has been validated as a diagnostic tool in ADHD.
Change in quality of life score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment. 12 weeks Quality of life assessed by the EFIQUACEE questionnaire (Echelle Française d'Impact et de Qualité de Vie Chez l'Enfant atteint d'Epilepsie).
The EFIQUACEE questionnaire is a unique quality of life scale for children suffering from epilepsy. It is validated in French language.Evolution of plasma lipid profiles in subjects assigned to supplementation of PS-Omega 3 in comparison with the placebo group after 12 weeks of treatment. 12 weeks Plasma levels before and after 12 weeks of treatment: total lipid mass ; total phospholipids ; individual phospholipids including: lysophosphatidylcholin, phosphatidylcholin, sphingomyelin, phosphatidylserine, phosphatidylinositol, phosphatidylethanolamine, diphosphatidylglycerol, lysophosphatidylethanolamine ; total triglycerides ; fatty acids profiles in phospholipids; fatty acids profiles in triglycerides ; fatty acids profiles in cholesterol esters.
After 24 weeks of treatment, description of the total score of ADHD Rating Scale. 24 weeks After 24 weeks of treatment, erythrocyte lipid levels before and after treatment. 24 weeks Quantification of, in erythrocyte membrane, before and after 24 weeks of treatment: total lipid mass ; total phospholipids ; individual phospholipids including: lysophosphatidylcholin, phosphatidylcholin, sphingomyelin, phosphatidylserine, phosphatidylinositol, phosphatidylethanolamine, diphosphatidylglycerol, lysophosphatidylethanolamine ; total triglycerides ; fatty acids profiles in phospholipids; fatty acids profiles in triglycerides ; fatty acids profiles in cholesterol esters.
Tolerance of a supplementation of PS-Omega 3. 36 weeks Tolerance analysis of the supplementation of PS-Omega 3: interrogatoire, phone calls, clinical examinations, adverse events reported throughout the study.
Reduction of the ADHD Rating Scale-IV total score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment. 12 weeks The ADHD Rating Scale-IV quantifies each of the 18 symptoms of ADHD on a 0 to 3 scale, with a maximum score of 54 points.
Proportion of subjects with a normalized TOVA score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment. 12 weeks The TOVA (Test of Variables of Attention) is a computerized tool assessing the capacity of attention and impulse control. This test has been validated as a diagnostic tool in ADHD.
After 24 weeks of treatment, proportion of subjects with a normalized TOVA score. 24 weeks After 24 weeks of treatment, description of the total score of TOVA. 24 weeks After 24 weeks of treatment, plasma lipid levels before and after treatment. 24 weeks Plasma levels before and after 24 weeks of treatment: total lipid mass ; total phospholipids ; individual phospholipids including: lysophosphatidylcholin, phosphatidylcholin, sphingomyelin, phosphatidylserine, phosphatidylinositol, phosphatidylethanolamine, diphosphatidylglycerol, lysophosphatidylethanolamine ; total triglycerides ; fatty acids profiles in phospholipids; fatty acids profiles in triglycerides ; fatty acids profiles in cholesterol esters.
Trial Locations
- Locations (13)
Hôpital de la Timone
🇫🇷Marseille, France
Hôpital Robert-Debré
🇫🇷Paris, France
CHRU Lille
🇫🇷Lille, France
Hôpital de Hautepierre
🇫🇷Strasbourg, France
CHU de Tours
🇫🇷Tours, France
Hôpital Necker-Enfants malades
🇫🇷Paris, France
CHU de Toulouse
🇫🇷Toulouse, France
CHU de Rennes
🇫🇷Rennes, France
Hôpital Brabois - Rue du Morvan
🇫🇷Vandoeuvre-les-Nancy, France
CHU de Amiens
🇫🇷Amiens, France
CHU d'Angers
🇫🇷Angers, France
Hôpital des Enfants - Pellegrin
🇫🇷Bordeaux, France
Hospices Civils de Lyon
🇫🇷Lyon, France