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Aripiprazole in the Treatment of Irritability in Children and Adolescents with Autism Spectrum Disorder in Japan: A Randomized, Double-blind, Placebo-controlled Study.
Child Psychiatry Hum Dev. 2017 10; 48(5):796-806.CP

Abstract

We evaluated the efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents (6-17 years) with autism spectrum disorder (ASD) in a randomized, double-blind, placebo-controlled 8-week study in Japan. Patients received flexibly dosed aripiprazole (1-15 mg/day) or placebo. Ninety-two patients were randomized to placebo (n = 45) or aripiprazole (n = 47). Aripiprazole produced a significant improvement in the mean parent/caregiver-rated Aberrant Behavior Checklist Japanese Version irritability subscale score relative to placebo from week 3 through week 8. Administration of aripiprazole provided significantly greater improvement in the mean clinician-rated Clinical Global Impression-Improvement scores than placebo from week 2 through week 8. All patients randomized to aripiprazole completed the study, and no serious adverse events were reported. Three patients in placebo group discontinued. Aripiprazole was effective and generally safe and well-tolerated in the treatment of irritability associated with ASD in Japanese children and adolescents.

Authors+Show Affiliations

Tokyo Metropolitan Children's Medical Center, Fuchu, Tokyo, Japan.Department of Psychiatry, Tokai University School of Medicine, Isehara, Kanagawa, Japan.Department of Child and Adolescent Psychiatry, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.Department of Pediatrics and Child Health, Kurume University School of Medicine, Kurume, Fukuoka, Japan.Department of Pediatrics, Kansai Medical University Medical Center, Moriguchi, Osaka, Japan.Research Center for Child Mental Development, University of Fukui, Fukui, Japan.Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd., Minato-ku, Tokyo, Japan.Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd., Minato-ku, Tokyo, Japan.Department of Medical Affairs, Otsuka Pharmaceutical Co., Ltd., Minato-ku, Tokyo, Japan. Tadori.Yoshihiro@otsuka.jp.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28004215

Citation

Ichikawa, Hironobu, et al. "Aripiprazole in the Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder in Japan: a Randomized, Double-blind, Placebo-controlled Study." Child Psychiatry and Human Development, vol. 48, no. 5, 2017, pp. 796-806.
Ichikawa H, Mikami K, Okada T, et al. Aripiprazole in the Treatment of Irritability in Children and Adolescents with Autism Spectrum Disorder in Japan: A Randomized, Double-blind, Placebo-controlled Study. Child Psychiatry Hum Dev. 2017;48(5):796-806.
Ichikawa, H., Mikami, K., Okada, T., Yamashita, Y., Ishizaki, Y., Tomoda, A., Ono, H., Usuki, C., & Tadori, Y. (2017). Aripiprazole in the Treatment of Irritability in Children and Adolescents with Autism Spectrum Disorder in Japan: A Randomized, Double-blind, Placebo-controlled Study. Child Psychiatry and Human Development, 48(5), 796-806. https://doi.org/10.1007/s10578-016-0704-x
Ichikawa H, et al. Aripiprazole in the Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder in Japan: a Randomized, Double-blind, Placebo-controlled Study. Child Psychiatry Hum Dev. 2017;48(5):796-806. PubMed PMID: 28004215.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Aripiprazole in the Treatment of Irritability in Children and Adolescents with Autism Spectrum Disorder in Japan: A Randomized, Double-blind, Placebo-controlled Study. AU - Ichikawa,Hironobu, AU - Mikami,Katsunaka, AU - Okada,Takashi, AU - Yamashita,Yushiro, AU - Ishizaki,Yuko, AU - Tomoda,Akemi, AU - Ono,Hiroaki, AU - Usuki,Chiharu, AU - Tadori,Yoshihiro, PY - 2016/12/23/pubmed PY - 2018/6/16/medline PY - 2016/12/23/entrez KW - Aripiprazole KW - Autism spectrum disorder KW - Children and adolescent KW - Irritability SP - 796 EP - 806 JF - Child psychiatry and human development JO - Child Psychiatry Hum Dev VL - 48 IS - 5 N2 - We evaluated the efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents (6-17 years) with autism spectrum disorder (ASD) in a randomized, double-blind, placebo-controlled 8-week study in Japan. Patients received flexibly dosed aripiprazole (1-15 mg/day) or placebo. Ninety-two patients were randomized to placebo (n = 45) or aripiprazole (n = 47). Aripiprazole produced a significant improvement in the mean parent/caregiver-rated Aberrant Behavior Checklist Japanese Version irritability subscale score relative to placebo from week 3 through week 8. Administration of aripiprazole provided significantly greater improvement in the mean clinician-rated Clinical Global Impression-Improvement scores than placebo from week 2 through week 8. All patients randomized to aripiprazole completed the study, and no serious adverse events were reported. Three patients in placebo group discontinued. Aripiprazole was effective and generally safe and well-tolerated in the treatment of irritability associated with ASD in Japanese children and adolescents. SN - 1573-3327 UR - https://www.unboundmedicine.com/medline/citation/28004215/Aripiprazole_in_the_Treatment_of_Irritability_in_Children_and_Adolescents_with_Autism_Spectrum_Disorder_in_Japan:_A_Randomized_Double_blind_Placebo_controlled_Study_ L2 - https://doi.org/10.1007/s10578-016-0704-x DB - PRIME DP - Unbound Medicine ER -