Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02348073 : Efficacy of Phosphatidylserine Enriched With n-3 PUFA Supplementation on ADHD in Children With Epilepsy
PhasePhase 3
AgesMin: 6 Years Max: 16 Years
Eligibility
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 IV 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).

- Diagnosis of a psychiatric comorbidity other than ADHD according to the DSM IV
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02348073      |      Link to official Clinicaltrials.gov listing
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