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Cilostazol As Adjunctive Therapy in Treatment of Children With Autism Spectrum Disorders: A Double-Blind and Placebo-Controlled Randomized Trial Publisher Pubmed



Ebrahimi P1 ; Seyedmirzaei H2 ; Moradi K1 ; Bagheri S1 ; Moeini M3 ; Mohammadi MR1 ; Akhondzadeh S1
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Authors Affiliations
  1. 1. Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Iran
  2. 2. Interdisciplinary Neuroscience Research Program (INRP), Tehran University of Medical Sciences, Iran
  3. 3. Department of Psychology, Faculty of Psychology and Education, Allameh Tabatabaei University, Tehran, Iran

Source: International Clinical Psychopharmacology Published:2023


Abstract

We aimed to evaluate cilostazol therapeutic effects on aberrant behaviors of autism spectrum disorder (ASD) children and its safety profile in a double-blind, randomized clinical trial. Sixty-six children with confirmed ASD were allocated to receive either daily 50-mg cilostazol (increased to 100 mg/day after 2 weeks) or matched placebo in addition to risperidone. The Aberrant Behavior Checklist-Community Edition (ABC-C) scale and a checklist of probable adverse effects were used to assess the behavioral outcomes and safety profile at weeks 0, 5, and 10 of the study. Sixty-one participants, with comparable baseline characteristics, completed the trial. Unlike other ABC-C subscales, repeated-measures analysis showed significant effect for time × treatment interaction in the hyperactivity subscale (P = 0.047; partial eta squared = 0.06). We used the median value for the baseline score hyperactivity subscale [median (interquartile range) = 31 (24-37)] to stratify participants to higher hyperactivity and lower hyperactivity subgroups and found that only participants with higher hyperactivity benefit from cilostazol adjunctive therapy (P = 0.028; partial eta squared = 0.14). Cilostazol could be considered as a safe agent with beneficial effects on hyperactivity in children with ASD and higher levels of hyperactivity. © 2023 Lippincott Williams and Wilkins. All rights reserved.
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