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

NCT02348073 | Completed Phase 3 DMC

• 1 other identifier: 2012-747
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 13

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,
• on attention disorders in children with epilepsy,
• on quality of life,
• 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

Keywords

Epilepsy; Attention Deficit Disorders; VAYARIN; Children; Polyunsaturated n-3 fatty acid supplementation

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  12 weeks

Secondary Outcomes (14)

• 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

• Reduction of TOVA total score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment.

  12 weeks

• 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

• Change in quality of life score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment.

  12 weeks

• 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

Study Arms (2)

PS-OMEGA 3, capsules twice daily

ACTIVE COMPARATOR

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.

Drug: Vayarin®, supplementation of n-3 PUFA

PLACEBO, capsules twice daily

PLACEBO COMPARATOR

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.

Drug: PLACEBO

Interventions

Vayarin®, supplementation of n-3 PUFA 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.

PS-OMEGA 3, capsules twice daily

PLACEBO 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.

PLACEBO, capsules twice daily

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 to 15 years and 11 months.
• Children of either sex (male/female) suffering from epilepsy regardless of syndrome classification.
• 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.

You may not qualify if:

• Subjects less than 6 years or older than 16 years old
• Diagnosis of ADHD hyperactivity type exclusive according to DSM V criteria.
• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (13)

CHU de Amiens

Amiens, France

Location

CHU d'Angers

Angers, France

Location

Hôpital des Enfants - Pellegrin

Bordeaux, France

Location

CHRU Lille

Lille, France

Location

Hospices Civils de Lyon

Lyon, France

Location

Hôpital de la Timone

Marseille, France

Location

Hôpital Necker-Enfants malades

Paris, France

Location

Hôpital Robert-Debré

Paris, France

Location

CHU de Rennes

Rennes, France

Location

Hôpital de Hautepierre

Strasbourg, France

Location

CHU de Toulouse

Toulouse, France

Location

CHU de Tours

Tours, France

Location

Hôpital Brabois - Rue du Morvan

Vandœuvre-lès-Nancy, France

Location

Related Publications (2)

• 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.

  PMID: 38173190 RESULT

• 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.

  PMID: 37058600 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Epilepsy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sylvain Rheims, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: January 28, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: August 6, 2025

Record last verified: 2019-03

Locations

FR (13)