1. Ichikawa H, Hiratani M, Yasuhara A, Tsujii N, Oshimo T, Ono H, Tadori Y. {{An open-label extension long-term study of the safety and efficacy of aripiprazole for irritability in children and adolescents with autistic disorder in Japan}}. {Psychiatry Clin Neurosci}. 2017.
AIMS: The purpose of this study was to evaluate the long-term safety and efficacy of aripiprazole in treating irritability in pediatric patients (6-17 years) with autistic disorder (AD) in Japan. METHODS: In this open-label extension study, patients who completed a previous randomized, double-blind, placebo-controlled 8-week study were enrolled and were flexibly dosed with aripiprazole (1-15 mg/day) until the new indication of irritability in pediatric autism spectrum disorder was approved in Japan. RESULTS: Seventy (81%) out of 86 enrolled patients completed week 48 assessments. The mean duration of treatment was 694.9 days. The mean daily dose of aripiprazole over the treatment period was 7.2 mg and the mean of the final dose was 8.5 mg. The most common treatment-emergent adverse events (TEAEs) (>/=20%) included nasopharyngitis, somnolence, influenza, and weight increased. The majority of these TEAEs were mild or moderate in severity, and there were no deaths, and no clinically relevant findings in laboratory values except prolactin decrease, vital signs, height, or ECG parameters. At week 48 (observed case), the mean change from baseline in Aberrant Behavior Checklist Japanese Version irritability subscale score was -6.3 in prior placebo patients and -2.6 in prior aripiprazole patients. CONCLUSIONS: Aripiprazole was generally safe, well tolerated and effective in the long-term treatment of irritability associated with AD in Japanese pediatric patients. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT01617460).
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2. Waye MMY, Cheng HY. {{Genetics and Epigenetics of Autism (Review)}}. {Psychiatry Clin Neurosci}. 2017.
Autism is a developmental disorder that starts before age 3, and children with autism has impairment in both social interaction and communication, and has restricted, repetitive and stereotyped patterns of behavior, interests and activities. There is a strong heritable component of autism and autism spectrum disorder as studies have shown that parents who have a child with ASD have a 2-18% chance of having a second child with ASD. Since the prevalence of autism and autism spectrum disorders have been increasing during the last 3 decades, much research has been carried out to understand the etiology, so as to develop novel preventive and treatment strategies. This review aims at summarizing the latest research studies related to autism and autism spectrum disorder, focusing not only on the genetics but also some epigenetic findings of autism/autism spectrum disorder. Some promising areas of research using transgenic/knockout animals and some ideas related to potential novel treatment and prevention strategies will be discussed.
