Clinical trial NCT02348073: Efficacy of Phosphatidylserine Enriched With n-3 PUFA Supplementation on ADHD in Children With Epilepsy
Official title: Efficacy of Phosphatidylserine Enriched With Polyunsaturated n-3 Fatty Acid Supplementation on Attention Deficit Disorders in Children With Epilepsy. A Randomized Double-blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Disorder With Hyperactivity
ADHD Inattention or Mixed Type
Epilepsy
Child
Keywords: Epilepsy
Attention Deficit Disorders
VAYARIN
Children
Polyunsaturated n-3 fatty acid supplementation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 77
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
Secondary outcomes:
measure: 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.
timeFrame: 12 weeks
measure: Reduction of TOVA total score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment.
timeFrame: 12 weeks
measure: Proportion of subjects with a normalized TOVA score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment.
timeFrame: 12 weeks
measure: Change in quality of life score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
measure: Tolerance of a supplementation of PS-Omega 3.
timeFrame: 36 weeks
measure: 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.
timeFrame: 12 weeks
measure: After 24 weeks of treatment, description of the total score of ADHD Rating Scale.
timeFrame: 24 weeks
measure: After 24 weeks of treatment, description of the total score of TOVA.
timeFrame: 24 weeks
measure: After 24 weeks of treatment, proportion of subjects with a normalized TOVA score.
timeFrame: 24 weeks
measure: After 24 weeks of treatment, change in quality of life score (EFIQUACEE questionnaire).
timeFrame: 24 weeks
measure: After 24 weeks of treatment, plasma lipid levels before and after treatment.
timeFrame: 24 weeks
measure: After 24 weeks of treatment, erythrocyte lipid levels before and after treatment.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU de Amiens
city: Angers
country: France
facility: CHU d'Angers
city: Bordeaux
country: France
facility: Hôpital des Enfants - Pellegrin
city: Lille
country: France
facility: CHRU Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Hôpital de la Timone
city: Paris
country: France
facility: Hôpital Necker-Enfants malades
city: Paris
country: France
facility: Hôpital Robert-Debré
city: Rennes
country: France
facility: CHU de Rennes
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: CHU de Tours
city: Vandoeuvre-les-Nancy
country: France
facility: Hôpital Brabois - Rue du Morvan
Study officials:
affiliation: Hospices Civils de Lyon
name: Sylvain Rheims, MD
role: PRINCIPAL_INVESTIGATOR
References: