title: 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.
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.
  
  
  METHODS
  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.
authors.affiliation: ADHD Unit, Geha Mental Health Center, Petach-Tiqva, Israel. IManor@clalit.org.il
authors.forename: I
authors.initials: I
authors.lastname: Manor
authors.forename: A
authors.initials: A
authors.lastname: Magen
authors.forename: D
authors.initials: D
authors.lastname: Keidar
authors.forename: S
authors.initials: S
authors.lastname: Rosen
authors.forename: H
authors.initials: H
authors.lastname: Tasker
authors.forename: T
authors.initials: T
authors.lastname: Cohen
authors.forename: Y
authors.initials: Y
authors.lastname: Richter
authors.forename: D
authors.initials: D
authors.lastname: Zaaroor-Regev
authors.forename: Y
authors.initials: Y
authors.lastname: Manor
authors.forename: A
authors.initials: A
authors.lastname: 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; D007175:Impulsive Behavior / Q000188:drug therapy*; D008297:Male; D010718:Phosphatidylserines / Q000009:adverse effects / Q000627:therapeutic use*; D012107:Research Design; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D015525:Fatty Acids, Omega-3; D010718:Phosphatidylserines