title: Efficacy and safety of aripiprazole once-monthly in Asian patients with schizophrenia: a multicenter, randomized, double-blind, non-inferiority study versus oral aripiprazole.
abstract: OBJECTIVE
  This study was designed to evaluate efficacy and safety of aripiprazole once-monthly (AOM) by verifying non-inferiority of AOM to oral aripiprazole in Asian patients with schizophrenia.
  
  
  METHODS
  The study consisted of a screening phase and three phases: an oral conversion phase (≤12weeks), an oral stabilization phase (≤12weeks) and a 52-week double-blind phase. Patients meeting stabilization criteria for 4weeks during the oral stabilization phase were randomly assigned (1:1) to AOM (400mg) or oral aripiprazole (6-24mg/day). The primary endpoint was Kaplan-Meier estimated rate of non-exacerbation of psychotic symptoms/non-relapse at Week 26.
  
  
  RESULTS
  A total of 724 patients were screened, and 502 patients entered the oral stabilization phase. Of 455 patients randomized in the double-blind phase, 228 received AOM and 227 received oral aripiprazole. The non-exacerbation of psychotic symptoms/non-relapse rates at Week 26 were 95.0% (AOM) and 94.7% (oral aripiprazole) and the difference was 0.3% (95% CI: -3.9,4.5), thus non-inferiority of AOM compared to oral aripiprazole with respect to non-exacerbation of psychotic symptoms/non-relapse rate was shown with a margin of -3.9% which is well above the pre-defined non-inferiority limit (-15%). The proportions of patients meeting exacerbation of psychotic symptoms/relapse criteria and stabilization of psychotic symptoms/maintenance criteria were 6.6% and 92.5% in both groups. Discontinuation rates due to all reasons were 25.9% (AOM) and 33.5% (oral aripiprazole). AOM was well tolerated as well as oral aripiprazole.
  
  
  CONCLUSIONS
  Non-inferiority of AOM to oral aripiprazole was established. AOM is efficacious in maintenance treatment of stabilized schizophrenia, with comparable efficacy and tolerability to oral aripiprazole.
  
  
  BACKGROUND
  JapicCTI-101175.
authors.affiliation: Department of Psychiatry, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan. Electronic address: ishigooka.jun@twmu.ac.jp.
authors.forename: Jun
authors.initials: J
authors.lastname: Ishigooka
authors.affiliation: Department of Psychiatry, School of Medicine University of Occupational and Environmental Health, 1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka 807-8555, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Nakamura
authors.affiliation: Department of Neuropsychiatry, Yamanashi Prefectural Kita Hospital, 3314-13, Kamijou-minamiwari Asahimachi, Nirasakishi, Yamanashi 407-0046, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Fujii
authors.affiliation: Department of Psychiatry, Fujita Health University School of Medicine, 1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan.
authors.forename: Nakao
authors.initials: N
authors.lastname: Iwata
authors.affiliation: Department of Psychiatry, Nara Medical University School of Medicine, 840 Shijo-cho, Kashihara, Nara 634-8521, Japan.
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Kishimoto
authors.affiliation: Department of Psychiatry, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuou-ku, Chiba 260-8670, Japan.
authors.forename: Masaomi
authors.initials: M
authors.lastname: Iyo
authors.affiliation: Department of Neuropsychiatry, Kurume University School of Medicine, 67 Asahimachi, Kurume, Fukuoka 830-0011, Japan.
authors.forename: Naohisa
authors.initials: N
authors.lastname: Uchimura
authors.affiliation: Department of Psychiatry, Faculty of Medicine, Fukuoka University, 8-19-1, Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan.
authors.forename: Ryoji
authors.initials: R
authors.lastname: Nishimura
authors.affiliation: Otsuka Pharmaceutical Co., Ltd., Shinagawa Grand Central Tower, 2-16-4, Konan, Minato-ku, Tokyo 108-8242, Japan.
authors.forename: Naoaki
authors.initials: N
authors.lastname: Shimizu
mesh_terms: D000284:Administration, Oral; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000068180:Aripiprazole / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007267:Injections / Q000009:adverse effects; D007564:Japan; D053208:Kaplan-Meier Estimate; D008296:Malaysia; D008297:Male; D010679:Philippines; D011569:Psychiatric Status Rating Scales; D012559:Schizophrenia / Q000188:drug therapy*; D013624:Taiwan; D016896:Treatment Outcome; D015430:Weight Gain
chemical_list: D014150:Antipsychotic Agents; D000068180:Aripiprazole
keywords: Aripiprazole; Asian; Efficacy; Long-acting injection; Safety; Schizophrenia