title: Safety of phosphatidylserine containing omega3 fatty acids in ADHD children: a double-blind placebo-controlled trial followed by an open-label extension.
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 (300mg 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 (150mg 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.
authors: ADHD Unit, Geha Mental Health Center, Petach-Tiqva, Israel. daphna@enzymotec.com
authors: I
authors: I
authors: Manor
authors: A
authors: A
authors: Magen
authors: D
authors: D
authors: Keidar
authors: S
authors: S
authors: Rosen
authors: H
authors: H
authors: Tasker
authors: T
authors: T
authors: Cohen
authors: Y
authors: Y
authors: Richter
authors: D
authors: D
authors: Zaaroor-Regev
authors: Y
authors: Y
authors: Manor
authors: A
authors: A
authors: Weizman
mesh_terms: D000293:Adolescent; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D015525:Fatty Acids, Omega-3 / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D010718:Phosphatidylserines / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D015525:Fatty Acids, Omega-3; D010718:Phosphatidylserines
keywords: ADHD; Docosahexaenoic acid (DHA); Eicosapentaenoic acid (EPA); Omega3; Phosphatidylserine (PS)