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Efficacy and Safety of N-3 Phosphatidylserine in Children with Attention Deficit and Hyperactivity Disorder (ADHD)

Published online by Cambridge University Press:  16 April 2020

I. Manor
Affiliation:
ADHD Unit, Geha Mental Health Center, Sackler Faculty of Medicine, Tel Aviv University, Petach-Tiqva, Israel
S. Rozen
Affiliation:
ADHD Unit, Geha Mental Health Center, Petach-Tikva, Israel
Y. Manor
Affiliation:
R&D Department, Enzymotec LTD, Migdal-HaEmeq, Israel
D. Pelled
Affiliation:
R&D Department, Enzymotec LTD, Migdal-HaEmeq, Israel
A. Weizman
Affiliation:
Research Unit, Geha Mental Health Center, 5 Felsenstein Medical Research Center, Beilinson Campus, Tel-Aviv University, Petach Tikva, Israel

Abstract

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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.

Type
S01-03
Copyright
Copyright © European Psychiatric Association 2009
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