title: Aripiprazole in the Treatment of Irritability in Children and Adolescents with Autism Spectrum Disorder in Japan: A Randomized, Double-blind, Placebo-controlled Study.
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.affiliation: Tokyo Metropolitan Children's Medical Center, Fuchu, Tokyo, Japan.
authors.forename: Hironobu
authors.initials: H
authors.lastname: Ichikawa
authors.affiliation: Department of Psychiatry, Tokai University School of Medicine, Isehara, Kanagawa, Japan.
authors.forename: Katsunaka
authors.initials: K
authors.lastname: Mikami
authors.affiliation: Department of Child and Adolescent Psychiatry, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Okada
authors.affiliation: Department of Pediatrics and Child Health, Kurume University School of Medicine, Kurume, Fukuoka, Japan.
authors.forename: Yushiro
authors.initials: Y
authors.lastname: Yamashita
authors.affiliation: Department of Pediatrics, Kansai Medical University Medical Center, Moriguchi, Osaka, Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Ishizaki
authors.affiliation: Research Center for Child Mental Development, University of Fukui, Fukui, Japan.
authors.forename: Akemi
authors.initials: A
authors.lastname: Tomoda
authors.affiliation: Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd., Minato-ku, Tokyo, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Ono
authors.affiliation: Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd., Minato-ku, Tokyo, Japan.
authors.forename: Chiharu
authors.initials: C
authors.lastname: Usuki
authors.affiliation: Department of Medical Affairs, Otsuka Pharmaceutical Co., Ltd., Minato-ku, Tokyo, Japan. Tadori.Yoshihiro@otsuka.jp.
authors.forename: Yoshihiro
authors.identifier: 0000-0002-9752-8949
authors.initials: Y
authors.lastname: Tadori
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D000068180:Aripiprazole / Q000494:pharmacology / Q000627:therapeutic use*; D000067877:Autism Spectrum Disorder / Q000188:drug therapy* / Q000523:psychology; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007508:Irritable Mood / Q000187:drug effects*; D007564:Japan; D008297:Male; D010290:Parents; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D000068180:Aripiprazole
keywords: Aripiprazole; Autism spectrum disorder; Children and adolescent; Irritability