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Br J Psychiatry. 2014 Aug;205(2):135-44. doi: 10.1192/bjp.bp.113.134213. Epub 2014 Jun 12.

Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study.

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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.



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). (



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).


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.

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