Attention Deficit Disorder With HyperactivityPhase 3AGPIn3NCT02348073

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

A Phase 3 study testing Vayarin®, supplementation of n-3 PUFA in people with Attention Deficit Disorder With Hyperactivity and ADHD Inattention or Mixed Type, run by Hospices Civils de Lyon at 13 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 6 to 16 years
Conditions the study is for: Attention Deficit Disorder With Hyperactivity, ADHD Inattention or Mixed Type, Epilepsy
What is being tested?: Vayarin®, supplementation of n-3 PUFA
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 77 participants
Where: 13 sitesFrance
Study dates: Mar 2015to Oct 2018
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Show all 12Show fewer

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 locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

France13 sites

CHU de Amiens
Amiens
CHU d'Angers
Angers
Hôpital des Enfants - Pellegrin
Bordeaux
CHRU Lille
Lille
Hospices Civils de Lyon
Lyon
Hôpital de la Timone
Marseille
Hôpital Necker-Enfants malades
Paris
Hôpital Robert-Debré
Paris
CHU de Rennes
Rennes
Hôpital de Hautepierre
Strasbourg
CHU de Toulouse
Toulouse
CHU de Tours
Tours
Hôpital Brabois - Rue du Morvan
Vandœuvre-lès-Nancy

Other trials in France

About this study

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

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
Being tested: Vayarin®, supplementation of n-3 PUFA, PLACEBO
Keywords: Epilepsy, Attention Deficit Disorders, VAYARIN, Children, Polyunsaturated n-3 fatty acid supplementation
Medical subject headings: Attention Deficit Disorder with Hyperactivity, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vayarin®, supplementation of n-3 PUFADrug
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.
PLACEBODrug
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.

Study groups in NCT02348073
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: PLACEBO

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
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.
Measured: 12 weeks
Reduction of TOVA total score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment.
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.
Measured: 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.
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.
Measured: 12 weeks
Change in quality of life score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment.
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.
Measured: 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.
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.
Measured: 12 weeks
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.
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.
Measured: 12 weeks
Tolerance of a supplementation of PS-Omega 3.
Tolerance analysis of the supplementation of PS-Omega 3: interrogatoire, phone calls, clinical examinations, adverse events reported throughout the study.
Measured: 36 weeks
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.
Measured: 12 weeks
After 24 weeks of treatment, description of the total score of ADHD Rating Scale.
Measured: 24 weeks
After 24 weeks of treatment, description of the total score of TOVA.
Measured: 24 weeks
After 24 weeks of treatment, proportion of subjects with a normalized TOVA score.
Measured: 24 weeks
After 24 weeks of treatment, change in quality of life score (EFIQUACEE questionnaire).
Measured: 24 weeks
After 24 weeks of treatment, plasma lipid levels before and after treatment.
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.
Measured: 24 weeks
After 24 weeks of treatment, erythrocyte lipid levels before and after treatment.
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.
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Oct 2018

First posted28 Jan 2015 (estimated)
Study startMar 2015
Primary completionOct 2018
Study completionOct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02348073
Sponsor's protocol ID: 2012-747
Acronym: AGPIn3
Status last verified: Mar 2019
First submitted: 22 Jan 2015
Last updated: 6 Aug 2025
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 38173190
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.
PubMed 37058600

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02348073
Acronym / sponsor ID: AGPIn3 / 2012-747
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
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Hospices Civils de LyonUniversity, hospital or other
Study start: Mar 2015 (actual)
Primary completion: Oct 2018 (actual)
Study completion: Oct 2018 (actual)
First posted: 28 Jan 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
PS-OMEGA 3, capsules twice daily	Active comparator	Drug: Vayarin®, supplementation of n-3 PUFAVayarin®, 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 comparator	Drug: PLACEBOThe 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.

Who may qualify

Ages: 6 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vayarin®, supplementation of n-3 PUFATwo 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.	Drug	PS-OMEGA 3, capsules twice daily
PLACEBOTwo capsules will be swallowed twice daily, 20 to 30 minutes prior to breakfast and dinner, during 12 weeks, between visit 1 and visit 2.	Drug	PLACEBO, capsules twice daily

Primary outcome

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.
Time frame: 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.

14 secondary outcomes

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.
Time frame: 12 weeks
Reduction of TOVA total score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment.
Time frame: 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.
Time frame: 12 weeks
Change in quality of life score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment.
Time frame: 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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Tolerance of a supplementation of PS-Omega 3.
Time frame: 36 weeks
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.
Time frame: 12 weeks
After 24 weeks of treatment, description of the total score of ADHD Rating Scale.
Time frame: 24 weeks
After 24 weeks of treatment, description of the total score of TOVA.
Time frame: 24 weeks
After 24 weeks of treatment, proportion of subjects with a normalized TOVA score.
Time frame: 24 weeks
After 24 weeks of treatment, change in quality of life score (EFIQUACEE questionnaire).
Time frame: 24 weeks
After 24 weeks of treatment, plasma lipid levels before and after treatment.
Time frame: 24 weeks
After 24 weeks of treatment, erythrocyte lipid levels before and after treatment.
Time frame: 24 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
Results publication: PubMed 38173190Rheims 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.
Derived from this study: PubMed 37058600Gillies 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sylvain Rheims, MD principal investigator

Hospices Civils de Lyon

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02348073, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.