S01-03 Efficacy and safety of N-3 phosphatidylserine in children with attention deficit and hyperactivity disorder (ADHD)

Abstract

Attention-deficit/hyperactivity disorder (ADHD) encompasses a broad constellation of behavioral and learning problems. These patients are also characterized by low blood long-chain polyunsaturated fatty acid concentrations; however their supplementation effect on ADHD symptoms is not clear. It was recently (1) shown in children with inattention that consumption of n-3 phosphatidylserine (PS) for 3-mo favorably affected their visual sustained attention performance. We aimed to evaluate in children with ADHD the effect of n-3 PS on ADHD symptoms and wellbeing.Methods:In this 15-week, randomized, double-blind, placebo-controlled, parallel study the impact and tolerability of 150 mg b.i.d. n-3 PS were investigated in 200 children (6-13-y) with ADHD. Efficacy was assessed by teachers’ Conners Rating Scale (CRS) and strength and difficulties questionnaires (SDQ) - school version and clinicians who filled Clinical Global Impression of Improvement. Additional measures included parental rating of behavior (CRS and SDQ - home version) and wellbeing (Child Health questionnaire - Parental Form 50), and continuous performance test (Test of Variables of Attention). Safety evaluation included adverse event reports, vital signs, and parents’ Barkley’ side effects rating scale.Results:The interim results of the first group of children that were randomly assigned in a 2:1 ratio to n-3 PS or placebo will be presented.Conclusions:n-3 PS impact on ADHD symptoms at school and home as evaluated by teachers, clinicians, and parents will be discussed.Acknowledgement:This work was sponsored by Enzymotec LTD.