title: Effects of aripiprazole once-monthly on symptoms of schizophrenia in patients switched from oral antipsychotics.
abstract: To assess the effects of aripiprazole once-monthly 400 mg (AOM 400) on clinical symptoms and global improvement in schizophrenia after switching from an oral antipsychotic.
  
  
  
  In a multicenter, open-label, mirror-image, naturalistic study in patients with schizophrenia (>1 year, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision [DSM-IV-TR] criteria), changes in efficacy measures were assessed during prospective treatment (6 months) with AOM 400 after switching from standard-of-care oral antipsychotics. During prospective treatment, patients were cross-titrated to oral aripiprazole monotherapy (1-4) weeks followed by open-label AOM 400 (24 weeks). Mean change from baseline of the open-label AOM 400 phase in Positive and Negative Syndrome Scale (PANSS) scores (total, positive and negative subscales) and Clinical Global Impression-Severity (CGI-S) scores; mean CGI-Improvement (CGI-I) score; and proportion of responders (≥30% decrease from baseline in PANSS total score or CGI-I score of 1 [very much improved] or 2 [much improved]) were assessed.
  
  
  
  PANSS and CGI-S scores improved from baseline (P<0.0001) and CGI-I demonstrated improvement at all time points. By the end of the study, 49.0% of patients were PANSS or CGI-I responders.
  
  
  
  In a community setting, patients with schizophrenia who were stabilized at baseline and switched to AOM 400 from oral antipsychotics showed clear improvements in clinical symptoms.
authors.affiliation: Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
authors.forename: Timothy
authors.initials: T
authors.lastname: Peters-Strickland
authors.affiliation: Biostatistics, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
authors.forename: Cathy
authors.initials: C
authors.lastname: Zhao
authors.affiliation: Clinical Management and Corporate Projects, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
authors.forename: Pamela P
authors.initials: PP
authors.lastname: Perry
authors.affiliation: Medical Affairs & Phase IV Clinical Affairs, Lundbeck LLC, Deerfield, IL, USA.
authors.forename: Anna
authors.initials: A
authors.lastname: Eramo
authors.affiliation: Global Medical Affairs, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
authors.forename: Phyllis M
authors.initials: PM
authors.lastname: Salzman
authors.affiliation: Executive Vice President and Chief Strategic Officer, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
authors.forename: Robert D
authors.initials: RD
authors.lastname: McQuade
authors.affiliation: Clinical Management, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
authors.forename: Brian R
authors.initials: BR
authors.lastname: Johnson
authors.affiliation: Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
authors.forename: Raymond
authors.initials: R
authors.lastname: Sanchez
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D000068180:Aripiprazole / Q000008:administration & dosage* / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D000068180:Aripiprazole
keywords: Antipsychotic agent; aripiprazole once-monthly; long-acting injectable; naturalistic study; schizophrenia