title: Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study.
abstract: BACKGROUND
  Long-acting injectable formulations of antipsychotics are treatment alternatives to oral agents.
  
  
  OBJECTIVE
  To assess the efficacy of aripiprazole once-monthly compared with oral aripiprazole for maintenance treatment of schizophrenia.
  
  
  METHODS
  A 38-week, double-blind, active-controlled, non-inferiority study; randomisation (2:2:1) to aripiprazole once-monthly 400 mg, oral aripiprazole (10-30 mg/day) or aripiprazole once-monthly 50 mg (a dose below the therapeutic threshold for assay sensitivity). (
  
  
  BACKGROUND
  clinicaltrials.gov, NCT00706654.)
  
  
  RESULTS
  A total of 1118 patients were screened, and 662 responders to oral aripiprazole were randomised. Kaplan-Meier estimated impending relapse rates at week 26 were 7.12% for aripiprazole once-monthly 400 mg and 7.76% for oral aripiprazole. This difference (-0.64%, 95% CI -5.26 to 3.99) excluded the predefined non-inferiority margin of 11.5%. Treatments were superior to aripiprazole once-monthly 50 mg (21.80%, P < or = 0.001).
  
  
  CONCLUSIONS
  Aripiprazole once-monthly 400 mg was non-inferior to oral aripiprazole, and the reduction in Kaplan-Meier estimated impending relapse rate at week 26 was statistically significant v. aripiprazole once-monthly 50 mg.
authors.affiliation: W. Wolfgang Fleischhacker, MD, Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria; Raymond Sanchez, MD, Pamela P. Perry, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Na Jin, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA; Timothy Peters-Strickland, MD, Brian R. Johnson, MS, Ross A. Baker, PhD, MBA, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Anna Eramo, MD, Lundbeck LLC, Deerfield, Illinois, USA; Robert D. McQuade, PhD, William H. Carson, MD, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; David Walling, PhD, Collaborative NeuroScience Network, Inc., Garden Grove, California, USA; John M. Kane, MD, The Zucker Hillside Hospital, Glen Oaks, and the Hofstra North Shore-LIJ School of Medicine, Hempstead, New York, USA.
authors.forename: W Wolfgang
authors.initials: WW
authors.lastname: Fleischhacker
authors.affiliation: W. Wolfgang Fleischhacker, MD, Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria; Raymond Sanchez, MD, Pamela P. Perry, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Na Jin, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA; Timothy Peters-Strickland, MD, Brian R. Johnson, MS, Ross A. Baker, PhD, MBA, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Anna Eramo, MD, Lundbeck LLC, Deerfield, Illinois, USA; Robert D. McQuade, PhD, William H. Carson, MD, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; David Walling, PhD, Collaborative NeuroScience Network, Inc., Garden Grove, California, USA; John M. Kane, MD, The Zucker Hillside Hospital, Glen Oaks, and the Hofstra North Shore-LIJ School of Medicine, Hempstead, New York, USA.
authors.forename: Raymond
authors.initials: R
authors.lastname: Sanchez
authors.affiliation: W. Wolfgang Fleischhacker, MD, Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria; Raymond Sanchez, MD, Pamela P. Perry, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Na Jin, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA; Timothy Peters-Strickland, MD, Brian R. Johnson, MS, Ross A. Baker, PhD, MBA, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Anna Eramo, MD, Lundbeck LLC, Deerfield, Illinois, USA; Robert D. McQuade, PhD, William H. Carson, MD, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; David Walling, PhD, Collaborative NeuroScience Network, Inc., Garden Grove, California, USA; John M. Kane, MD, The Zucker Hillside Hospital, Glen Oaks, and the Hofstra North Shore-LIJ School of Medicine, Hempstead, New York, USA.
authors.forename: Pamela P
authors.initials: PP
authors.lastname: Perry
authors.affiliation: W. Wolfgang Fleischhacker, MD, Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria; Raymond Sanchez, MD, Pamela P. Perry, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Na Jin, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA; Timothy Peters-Strickland, MD, Brian R. Johnson, MS, Ross A. Baker, PhD, MBA, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Anna Eramo, MD, Lundbeck LLC, Deerfield, Illinois, USA; Robert D. McQuade, PhD, William H. Carson, MD, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; David Walling, PhD, Collaborative NeuroScience Network, Inc., Garden Grove, California, USA; John M. Kane, MD, The Zucker Hillside Hospital, Glen Oaks, and the Hofstra North Shore-LIJ School of Medicine, Hempstead, New York, USA.
authors.forename: Na
authors.initials: N
authors.lastname: Jin
authors.affiliation: W. Wolfgang Fleischhacker, MD, Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria; Raymond Sanchez, MD, Pamela P. Perry, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Na Jin, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA; Timothy Peters-Strickland, MD, Brian R. Johnson, MS, Ross A. Baker, PhD, MBA, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Anna Eramo, MD, Lundbeck LLC, Deerfield, Illinois, USA; Robert D. McQuade, PhD, William H. Carson, MD, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; David Walling, PhD, Collaborative NeuroScience Network, Inc., Garden Grove, California, USA; John M. Kane, MD, The Zucker Hillside Hospital, Glen Oaks, and the Hofstra North Shore-LIJ School of Medicine, Hempstead, New York, USA.
authors.forename: Timothy
authors.initials: T
authors.lastname: Peters-Strickland
authors.affiliation: W. Wolfgang Fleischhacker, MD, Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria; Raymond Sanchez, MD, Pamela P. Perry, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Na Jin, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA; Timothy Peters-Strickland, MD, Brian R. Johnson, MS, Ross A. Baker, PhD, MBA, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Anna Eramo, MD, Lundbeck LLC, Deerfield, Illinois, USA; Robert D. McQuade, PhD, William H. Carson, MD, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; David Walling, PhD, Collaborative NeuroScience Network, Inc., Garden Grove, California, USA; John M. Kane, MD, The Zucker Hillside Hospital, Glen Oaks, and the Hofstra North Shore-LIJ School of Medicine, Hempstead, New York, USA.
authors.forename: Brian R
authors.initials: BR
authors.lastname: Johnson
authors.affiliation: W. Wolfgang Fleischhacker, MD, Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria; Raymond Sanchez, MD, Pamela P. Perry, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Na Jin, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA; Timothy Peters-Strickland, MD, Brian R. Johnson, MS, Ross A. Baker, PhD, MBA, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Anna Eramo, MD, Lundbeck LLC, Deerfield, Illinois, USA; Robert D. McQuade, PhD, William H. Carson, MD, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; David Walling, PhD, Collaborative NeuroScience Network, Inc., Garden Grove, California, USA; John M. Kane, MD, The Zucker Hillside Hospital, Glen Oaks, and the Hofstra North Shore-LIJ School of Medicine, Hempstead, New York, USA.
authors.forename: Ross A
authors.initials: RA
authors.lastname: Baker
authors.affiliation: W. Wolfgang Fleischhacker, MD, Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria; Raymond Sanchez, MD, Pamela P. Perry, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Na Jin, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA; Timothy Peters-Strickland, MD, Brian R. Johnson, MS, Ross A. Baker, PhD, MBA, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Anna Eramo, MD, Lundbeck LLC, Deerfield, Illinois, USA; Robert D. McQuade, PhD, William H. Carson, MD, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; David Walling, PhD, Collaborative NeuroScience Network, Inc., Garden Grove, California, USA; John M. Kane, MD, The Zucker Hillside Hospital, Glen Oaks, and the Hofstra North Shore-LIJ School of Medicine, Hempstead, New York, USA.
authors.forename: Anna
authors.initials: A
authors.lastname: Eramo
authors.affiliation: W. Wolfgang Fleischhacker, MD, Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria; Raymond Sanchez, MD, Pamela P. Perry, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Na Jin, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA; Timothy Peters-Strickland, MD, Brian R. Johnson, MS, Ross A. Baker, PhD, MBA, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Anna Eramo, MD, Lundbeck LLC, Deerfield, Illinois, USA; Robert D. McQuade, PhD, William H. Carson, MD, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; David Walling, PhD, Collaborative NeuroScience Network, Inc., Garden Grove, California, USA; John M. Kane, MD, The Zucker Hillside Hospital, Glen Oaks, and the Hofstra North Shore-LIJ School of Medicine, Hempstead, New York, USA.
authors.forename: Robert D
authors.initials: RD
authors.lastname: McQuade
authors.affiliation: W. Wolfgang Fleischhacker, MD, Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria; Raymond Sanchez, MD, Pamela P. Perry, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Na Jin, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA; Timothy Peters-Strickland, MD, Brian R. Johnson, MS, Ross A. Baker, PhD, MBA, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Anna Eramo, MD, Lundbeck LLC, Deerfield, Illinois, USA; Robert D. McQuade, PhD, William H. Carson, MD, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; David Walling, PhD, Collaborative NeuroScience Network, Inc., Garden Grove, California, USA; John M. Kane, MD, The Zucker Hillside Hospital, Glen Oaks, and the Hofstra North Shore-LIJ School of Medicine, Hempstead, New York, USA.
authors.forename: William H
authors.initials: WH
authors.lastname: Carson
authors.affiliation: W. Wolfgang Fleischhacker, MD, Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria; Raymond Sanchez, MD, Pamela P. Perry, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Na Jin, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA; Timothy Peters-Strickland, MD, Brian R. Johnson, MS, Ross A. Baker, PhD, MBA, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Anna Eramo, MD, Lundbeck LLC, Deerfield, Illinois, USA; Robert D. McQuade, PhD, William H. Carson, MD, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; David Walling, PhD, Collaborative NeuroScience Network, Inc., Garden Grove, California, USA; John M. Kane, MD, The Zucker Hillside Hospital, Glen Oaks, and the Hofstra North Shore-LIJ School of Medicine, Hempstead, New York, USA.
authors.forename: David
authors.initials: D
authors.lastname: Walling
authors.affiliation: W. Wolfgang Fleischhacker, MD, Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria; Raymond Sanchez, MD, Pamela P. Perry, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Na Jin, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA; Timothy Peters-Strickland, MD, Brian R. Johnson, MS, Ross A. Baker, PhD, MBA, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Anna Eramo, MD, Lundbeck LLC, Deerfield, Illinois, USA; Robert D. McQuade, PhD, William H. Carson, MD, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; David Walling, PhD, Collaborative NeuroScience Network, Inc., Garden Grove, California, USA; John M. Kane, MD, The Zucker Hillside Hospital, Glen Oaks, and the Hofstra North Shore-LIJ School of Medicine, Hempstead, New York, USA.
authors.forename: John M
authors.initials: JM
authors.lastname: Kane
mesh_terms: D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage*; D000068180:Aripiprazole; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage*; D015363:Quinolones / Q000008:administration & dosage*; D012008:Recurrence; D012559:Schizophrenia / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole