TY - JOUR ID - 9407 TI - Comparative Study on the Effect of Risperidone and its Combination with Naltrexone in Pediatric Patients with Autistic Spectrum Disorders: A Clinical Trial Study JO - International Journal of Pediatrics JA - IJP LA - en SN - 2345-5047 AU - Moharreri, Fatemeh AU - Abdollahian, Ebrahim AU - Hosseini, Seyedeh Azam AU - Mirzadeh, Mansoureh AD - Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Y1 - 2017 PY - 2017 VL - 5 IS - 12 SP - 6375 EP - 6382 KW - Autism KW - Children KW - Crossover design KW - Naltrexone KW - Risperidone DO - 10.22038/ijp.2017.18557.1516 N2 - Background Autistic spectrum disorder (ASD) refers to a syndrome associated with persistent impairments in communication skills, social interactions, and so forth. Given the approval of risperidone and naltrexone by U.S. Food and Drug Administration (FDA) for ASD cases and extant controversy concerning their pertained side effects, this double-blind, placebo-controlled, crossover clinical trial with 2-treatment, 2-sequence, 2-period design was intended to evaluate the behavioral effectiveness of individual risperidone and its combination with naltrexone in autistic children aged 4-12 years old. Materials and Methods A total of30 autistic children were recruited in this study, and then equally assigned into groups A and B. The first group underwent co-treatment with risperidone and naltrexone, while group B was instructed to use placebo and risperidone for 8 weeks. After a washout period of two weeks, treatments were crossed over for another 8 weeks. The behavioral changes were assessed applying the childhood autism rating scale (CARS). Results There were five out of 30 cases at the risk of drop-out due to side effect in group A, while only three failed to complete the trial in group B. The effect size of the combined treatment was greater than the individual which was manifest in the total score of CARS, improved 4-week listening response, and 8-week general impressions. Conclusion According to the results, naltrexone can be a promising candidate for the management of behavioral symptoms in autism children. UR - https://ijp.mums.ac.ir/article_9407.html L1 - https://ijp.mums.ac.ir/article_9407_7adc10f90fe276ac5d43b855d1c2f3bf.pdf ER -