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

NCT ID: NCT02348073

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2018-10-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PS-OMEGA 3, capsules twice daily

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.

Group Type: ACTIVE_COMPARATOR

Vayarin®, supplementation of n-3 PUFA

Intervention Type: DRUG

Two capsules will be swallowed twice daily, 20 to 30 minutes prior to breakfast and dinner, during 12 weeks, between visit 1 and visit 2.

At the end of this period, active product will be continued, at the same dose, for a 12 week-open label period. All patients will be administered the active product.

PLACEBO, capsules twice daily

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.

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DRUG

Two capsules will be swallowed twice daily, 20 to 30 minutes prior to breakfast and dinner, during 12 weeks, between visit 1 and visit 2.

Interventions

Vayarin®, supplementation of n-3 PUFA

Two capsules will be swallowed twice daily, 20 to 30 minutes prior to breakfast and dinner, during 12 weeks, between visit 1 and visit 2.

At the end of this period, active product will be continued, at the same dose, for a 12 week-open label period. All patients will be administered the active product.

Intervention Type: DRUG

PLACEBO

Two capsules will be swallowed twice daily, 20 to 30 minutes prior to breakfast and dinner, during 12 weeks, between visit 1 and visit 2.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvain Rheims, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

CHU de Amiens

Amiens, , France

CHU d'Angers

Angers, , France

Hôpital des Enfants - Pellegrin

Bordeaux, , France

CHRU Lille

Lille, , France

Hospices Civils de Lyon

Lyon, , France

Hôpital de la Timone

Marseille, , France

Hôpital Necker-Enfants malades

Paris, , France

Hôpital Robert-Debré

Paris, , France

CHU de Rennes

Rennes, , France

Hôpital de Hautepierre

Strasbourg, , France

CHU de Toulouse

Toulouse, , France

CHU de Tours

Tours, , France

Hôpital Brabois - Rue du Morvan

Vandœuvre-lès-Nancy, , France

Countries

France

References

Rheims S, Herbillon V, Gaillard S, Mercier C, Villeuve N, Villega F, Cances C, Castelnau P, Napuri S, de Saint-Martin A, Auvin S, Nguyen The Tich S, Berquin P, de Bellecize J, Milh M, Roy P, Arzimanoglou A, Bodennec J, Bezin L, Kassai B; investigators of the AGPI study group. Phosphatidylserine enriched with polyunsaturated n-3 fatty acid supplementation for attention-deficit hyperactivity disorder in children and adolescents with epilepsy: A randomized placebo-controlled trial. Epilepsia Open. 2024 Apr;9(2):582-591. doi: 10.1002/epi4.12892. Epub 2024 Jan 25.

Reference Type: RESULT

PMID: 38173190 (View on PubMed)

Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.

Reference Type: DERIVED

PMID: 37058600 (View on PubMed)

Other Identifiers

2012-747

Identifier Type: -

Identifier Source: org_study_id