Efficacy of Phosphatidylserine Enriched With n-3 PUFA Supplementation on ADHD in Children With Epilepsy (AGPIn3)

Civil Hospices of Lyon

Status and phase: Completed; Phase 3

Conditions: Epilepsy; Child; ADHD Inattention or Mixed Type; Attention Deficit Disorder With Hyperactivity

Treatments: Drug: PLACEBO; Drug: Vayarin®, supplementation of n-3 PUFA

Study type: Interventional

Funder types: Other

Identifiers

NCT02348073

2012-747

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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77 participants in 2 patient groups, including a placebo group

PS-OMEGA 3, capsules twice daily

Active Comparator group

Description:

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.

Treatment:

Drug: Vayarin®, supplementation of n-3 PUFA

PLACEBO, capsules twice daily

Placebo Comparator group

Description:

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.

Treatment:

Drug: PLACEBO