A Double-Blind Placebo-Controlled Trial of Acediprol (Valproate Sodium) For Global Severity in Child Autism Spectrum Disorders

Volume 2 - Issue 1

NA Aliyev¹* and ZN Aliyev²

Received: September 22, 2018;   Published: September 28, 2018

DOI: 10.32474/OJNBD.2018.01.000127

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Abstract

Objectives: The effects of Valproate sodium and placebo on global severity were compared in Child Autism Spectrum Disorders (ASD).

Materials and Methods: Childs with ASDs were enrolled in a 12-week double-blind placebo-controlled Valproate sodium trial. Fifty were randomly assigned to Valproate sodium (n=50) or placebo (n=50). The initial dose of Valproate sodium for children is 15mg/kg, then increases by 5-10mg/kg every week to 20-50mg/kg. Children are given 5% syrup (Sirupus Valproate sodium 5%), 1 ml 50mg. Repetitive behaviors were measured with the Clinical Global Impression (CGI) improvement scale.

Results: There was a significant treatment-by-time interaction indicating a significantly greater reduction in repetitive behaviors across time for Valproate sodium than for placebo. With overall response defined as a CGI global improvement score of 2 or less, there were significantly more responders at week 12 in the Valproate sodium group than in the placebo group. The risk ratio was 1.5 for CGI global improvement (responders: Valproate sodium, 80%; placebo, 12%). Side effects were not observed.

Conclusion: Valproate sodium treatment, compared to placebo, resulted in significantly greater improvement in global severity behaviors, according to CGI rating scale. Valproate sodium appeared to be well tolerated movement score of 2 or less, there were significantly more responders at week 12 in the Valproate sodium group than in the placebo group. The risk ratio was 1.5 for CGI global improvement (responders: Acedipro, 80%; placebo, 12%). Side effects were not observed.

Abstract| Introduction| Materials and Methods| Results | Discussion | Author Disclosure Information | Acknowledgment | References|