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Safety of phosphatidylserine containing omega3 fatty acids in ADHD children: A double-blind placebo-controlled trial followed by an open-label extension

Published online by Cambridge University Press:  15 April 2020

I. Manor ,
A. Magen ,
D. Keidar ,
S. Rosen ,
H. Tasker ,
T. Cohen ,
Y. Richter ,
D. Zaaroor-Regev ,
Y. Manor  and
A. Weizman
I. Manor*
Affiliation:
ADHD Unit, Geha Mental Health Center, Petach-Tiqva, Israel Felsenstein Medical Research Center, Rabin Medical Center, Petah Tikva, Israel Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
A. Magen
Affiliation:
ADHD Unit, Geha Mental Health Center, Petach-Tiqva, Israel
D. Keidar
Affiliation:
ADHD Unit, Geha Mental Health Center, Petach-Tiqva, Israel
S. Rosen
Affiliation:
ADHD Unit, Geha Mental Health Center, Petach-Tiqva, Israel
H. Tasker
Affiliation:
ADHD Unit, Geha Mental Health Center, Petach-Tiqva, 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, Petach-Tiqva, Israel Felsenstein Medical Research Center, Rabin Medical Center, Petah Tikva, Israel Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
*
*Corresponding author. E-mail address:[email protected] (I. Manor).
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Abstract

Objective:

To evaluate the safety of phosphatidylserine (PS) enriched with omega3 fatty acids, mainly eicosapentaenoic (PS-Omega3) in children with attention-deficit hyperactivity disorder (ADHD).

Methods:

Two hundred children diagnosed with ADHD were randomised to receive either PS-Omega3 (300 mg PS-Omega3/day) or placebo for 15 weeks. One hundred and fifty children continued into an open-label extension for an additional 15 weeks in which they all consumed PS-Omega3 (150 mg PS-Omega3/day). Standard blood biochemical and haematological safety parameters, blood pressure, heart rate, weight and height were evaluated. Adverse events and the Side Effect Rating Scale were also assessed.

Results:

One hundred and sixty-two participants completed the double-blind phase. No significant differences were noted between the two study groups in any of the safety parameters evaluated. One hundred and forty participants completed the open-label phase. At the end of this phase, no significant changes from baseline were observed in any of the studied parameters among participants who consumed PS-Omega3 for 30 weeks.

Conclusions:

Study results demonstrate that consumption of PS-Omega3 by children with ADHD, as indicated in a 30-week evaluation period, is safe and well tolerated, without any negative effect on body weight or growth.

Keywords

Phosphatidylserine (PS)Omega3ADHDDocosahexaenoic acid (DHA)Eicosapentaenoic acid (EPA)
Type
Original article
Information
European Psychiatry , Volume 28 , Issue 6 , August 2013 , pp. 386 - 391
Copyright
Copyright © European Psychiatric Association

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Footnotes

☆

Clinical trial registry information: A single-centre, randomised, double-blind, placebo-controlled study of the efficacy and safety of phosphatidylserine omega-3 in children with attention-deficit/hyperactivity disorder. URL: http://www.clinicaltrials.gov; unique identifier: NCT00418184.

References

Barkley, RAMcMurray, MBEdelbrock, CSRobbins, KSide effects of methylphenidate in children with attention-deficit hyperactivity disorder: a systemic, placebo-controlled evaluation. Pediatrics 1990;86:184–192.Google ScholarPubMed
James, MSwanson, NDVNewcorn, JCasey, BJMoyzis, RGrandy, D, et al. Attention-deficit hyperactivity disorder. Encyclopaedia of Cognitive Science. 2006.CrossRefGoogle Scholar
Jensen, PSClinical considerations for the diagnosis and treatment of ADHD in the managed care setting. Am J Manag Care 2009;15:S129–S140.Google ScholarPubMed
Manor, IMagen, AKeidar, DRosen, STasker, HCohen, T, et al.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. Eur Psychiatry 2012;5:335–342.CrossRefGoogle Scholar
Vaisman, NKaysar, NZaruk-Adasha, YPelled, DBrichon, GZwingelstein, G, et al.Correlation between changes in blood fatty acid composition and visual sustained attention performance in children with inattention: effect of dietary n-3 fatty acids containing phospholipids. Am J Clin Nutr 2008;87:1170–1180.CrossRefGoogle ScholarPubMed
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