Hostname: page-component-8448b6f56d-wq2xx Total loading time: 0 Render date: 2024-04-24T01:16:21.048Z Has data issue: false hasContentIssue false
  • English
  • Français

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:daphna@enzymotec.com (I. Manor).
Get access

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

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

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
Submit a response

Comments

No Comments have been published for this article.