W Wolfgang Fleischhacker1, Raymond Sanchez1, Pamela P Perry1, Na Jin1, Timothy Peters-Strickland1, Brian R Johnson1, Ross A Baker1, Anna Eramo1, Robert D McQuade1, William H Carson1, David Walling1, John M Kane1. 1. 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.
Abstract
BACKGROUND: Long-acting injectable formulations of antipsychotics are treatment alternatives to oral agents. AIMS: To assess the efficacy of aripiprazole once-monthly compared with oral aripiprazole for maintenance treatment of schizophrenia. METHOD: 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: clinicaltrials.gov, NCT00706654.) RESULTS: A total of 1118 patients were screened, and 662 responders to oralaripiprazole 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. Royal College of Psychiatrists.
RCT Entities:
BACKGROUND: Long-acting injectable formulations of antipsychotics are treatment alternatives to oral agents. AIMS: To assess the efficacy of aripiprazole once-monthly compared with oral aripiprazole for maintenance treatment of schizophrenia. METHOD: 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: 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. Royal College of Psychiatrists.
Authors: Marc De Hert; Anna Eramo; Wally Landsberg; Dusan Kostic; Lan-Feng Tsai; Ross A Baker Journal: Neuropsychiatr Dis Treat Date: 2015-05-27 Impact factor: 2.570