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

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• 作者：I. Manor^a ; ^b ; ^{IManor@clalit.org.il} ; ^{dan100@netvision.net.il} ; A. Magen^a ; D. Keidar^a ; S. Rosen^a ; H. Tasker^a ; T. Cohen^c ; Y. Richter^c ; D. Zaaroor-Regev^c ; Y. Manor^c ; A. Weizman^a ; ^b
• 关键词：Phosphatidylserine (PS) ; Omega3 ; ADHD ; Docosahexaenoic acid (DHA) ; Eicosapentaenoic acid (EPA)
• 刊名：European Psychiatry
• 出版年：2012
• 期刊代码：96_09249338
• 类别：med
• 出版时间：July, 2012
• 卷：27
• 期：5
• 页码：335-342
• 文件大小：362 K

摘要

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鈥?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.