Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study
W. Wolfgang Fleischhacker, Raymond Sanchez, Pamela P. Perry, Na Jin, Timothy Peters-Strickland, Brian R. Johnson, Ross A. Baker, Anna Eramo, Robert D. McQuade, William H. Carson, David Walling, John M. Kane

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  • Declaration of interest

    W.W.F. has received research grants from Otsuka, Pfizer, Janssen and Reckitt-Benckiser as well as consulting honoraria from Lundbeck, Roche, Bristol-Myers Squibb, Otsuka, Janssen, Pfizer, MedAvante, Takeda, Endo and Vanda. He has received speaker honoraria from Lundbeck, Janssen, Otsuka and Takeda as well as holds stock from MedAvante. R.S., P.P., N.J., T.P.-S., B.R.J., R.A.B., R.D.M. and W.H.C. are employees of Otsuka Pharmaceutical Commercialization, Inc. (Tokyo, Japan). A.E. is an employee of Lundbeck LLC. D.W. has received research grants from Otsuka, Pfizer, Eli Lilly, Janssen, Targacept, Lundbeck, Sunovion, Merck, Alkermes, Bristol-Myers Squibb, Reckitt, Elan, Abbott and Amgen. J.M.K. has received honoraria for lectures and/or consulting from Alkermes, Amgen, Bristol-Myers Squibb, Cephalon, Eisai, Boehringer Ingelheim, Eli Lilly, Forrest, Genentech, Intracellular Therapeutics, Janssen, Johnson and Johnson, Lundbeck, Merck, Novartis, Otsuka, Pfizer, Pierre Fabre, Proteus, Reviva, Roche, Sunovion and Targacept. He is a shareholder of MedAvante.



Long-acting injectable formulations of antipsychotics are treatment alternatives to oral agents.


To assess the efficacy of aripiprazole once-monthly compared with oral aripiprazole for maintenance treatment of schizophrenia.


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). (Trial registration:, NCT00706654.)


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⩽0.001).


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.


  • Funding

    This study was supported by Otsuka Pharmaceutical Commercialization, Inc. (Tokyo, Japan). Editorial support for the preparation of this manuscript was provided by Suzanne Patel at Ogilvy Healthworld Medical Education and Amy Roth Shaberman, PhD, and Brett D. Mahon, PhD, at C4 MedSolutions, LLC, a CHC Group company; funding was provided by Otsuka Pharmaceutical Commercialization, Inc. and H. Lundbeck A/S.

  • * Previously presented at the following conferences: 51st Annual Meeting of the American College of Neuropsychopharmacology (ACNP), 2-6 December 2012, Hollywood, Florida, USA; 14th International Congress on Schizophrenia Research (ICOSR), 21-25 April 2013, Orlando, Florida, USA; 166th Annual Meeting of the American Psychiatric Association (APA), 18-22 May 2013, San Francisco, California, USA; US Psychiatric and Mental Health Congress (USPMHC), 30 September-3 October 2013, Las Vegas, Nevada, USA; and Neuroscience Education Institute Psychopharmacology Congress (NEI), 14-17 November 2013, Colorado Springs, Colorado, USA.

    This paper has been corrected post-publication, in deviation from print and in accordance with a correction published in the November 2014 issue.

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