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The effect of phosphatidylserine containing Omega3 fatty-acids on attention-deficit hyperactivity disorder symptoms in children: A double-blind placebo-controlled trial, followed by an open-label extension

Published online by Cambridge University Press:  15 April 2020

I. Manor*
Affiliation:
ADHD Unit, Geha Mental Health Center, Jabotinsky 100, Petach-Tiqva, 49517, Israel Felsenstein Medical Research Center, Rabin Medical Center, Petah Tikva, Israel
A. Magen
Affiliation:
ADHD Unit, Geha Mental Health Center, Jabotinsky 100, Petach-Tiqva, 49517, Israel
D. Keidar
Affiliation:
ADHD Unit, Geha Mental Health Center, Jabotinsky 100, Petach-Tiqva, 49517, Israel
S. Rosen
Affiliation:
ADHD Unit, Geha Mental Health Center, Jabotinsky 100, Petach-Tiqva, 49517, Israel
H. Tasker
Affiliation:
ADHD Unit, Geha Mental Health Center, Jabotinsky 100, Petach-Tiqva, 49517, Israel
T. Cohen
Affiliation:
Enzymotec Ltd, Migdal HaEmeq, Israel
Y. Richter
Affiliation:
Enzymotec Ltd, Migdal HaEmeq, Israel
D. Zaaroor-Regev
Affiliation:
Enzymotec Ltd, Migdal HaEmeq, Israel
Y. Manor
Affiliation:
Enzymotec Ltd, Migdal HaEmeq, Israel
A. Weizman
Affiliation:
ADHD Unit, Geha Mental Health Center, Jabotinsky 100, Petach-Tiqva, 49517, Israel Felsenstein Medical Research Center, Rabin Medical Center, Petah Tikva, Israel
*
*Corresponding author. Tel.: +972 3 918 1600; fax: +972 3 921 5729. E-mail addresses: IManor@clalit.org.il, dan100@netvision.net.il (I. Manor).
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Abstract

Objective

To study the efficacy and safety of phosphatidylserine (PS) containing Omega3 long-chain polyunsaturated fatty acids attached to its backbone (PS-Omega3) in reducing attention-deficit/ hyperactivity disorder (ADHD) symptoms in children.

Method

A 15-week, double-blind, placebo-controlled phase followed by an open-label extension of additional 15 weeks. Two hundred ADHD children were randomized to receive either PS-Omega3 or placebo, out of them, 150 children continued into the extension. Efficacy was assessed using Conners’ parent and teacher rating scales (CRS-P,T), Strengths and Difficulties Questionnaire (SDQ), and Child Health Questionnaire (CHQ). Safety evaluation included adverse events monitoring.

Results

The key finding of the double-blind phase was the significant reduction in the Global:Restless/impulsive subscale of CRS-P and the significant improvement in Parent impact-emotional (PE) subscale of the CHQ, both in the PS-Omega3 group. Exploratory subgroup analysis of children with a more pronounced hyperactive/impulsive behavior, as well as mood and behavior-dysregulation, revealed a significant reduction in the ADHD-Index and hyperactive components. Data from the open-label extension indicated sustained efficacy for children who continued to receive PS-Omega3. Children that switched to PS-Omega3 treatment from placebo showed a significant reduction in subscales scores of both CRS-P and the CRS-T, as compare to baseline scores. The treatment was well tolerated.

Conclusions

The results of this 30-week study suggest that PS-Omega3 may reduce ADHD symptoms in children. Preliminary analysis suggests that this treatment may be especially effective in a subgroup of hyperactive-impulsive, emotionally and behaviorally-dysregulated ADHD children.

Type
Original articles
Copyright
Copyright © Elsevier Masson SAS 2012

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