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2277 – A Placebo-controlled Study Of Efficacy And Safety Of Aripiprazole Once-monthly For Long-term Maintenance Treatment In Schizophrenia

Published online by Cambridge University Press:  15 April 2020

A. Eramo
Affiliation:
Lundbeck LLC, Deerfield, IL, USA
W.W. Fleischhacker
Affiliation:
Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria
R. Sanchez
Affiliation:
Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ
P. Perry
Affiliation:
Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ
N. Jin
Affiliation:
Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, MD
B. Johnson
Affiliation:
Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ
R.D. McQuade
Affiliation:
Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ
W.H. Carson
Affiliation:
Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ
J. Kane
Affiliation:
The Zucker Hillside Hospital, Glen Oaks Hofstra North Shore-LIJ School of Medicine, Hempstead, NY, USA
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Abstract

Objective

Evaluate the efficacy and long-term safety of investigational aripiprazole once-monthly (ARI-OM) for maintenance treatment in schizophrenia.

Methods

Patients requiring chronic treatment for schizophrenia, not on aripiprazole monotherapy, were cross-titrated from other antipsychotic(s) to aripiprazole in an oral conversion phase (Phase 1). All patients entered an oral aripiprazole stabilization phase (Phase 2). Patients meeting stability criteria entered an ARI-OM stabilization phase (Phase 3), with coadministration of oral aripiprazole for the first 2 weeks. Patients meeting stability criteria were randomized to ARI-OM or placebo once-monthly (placebo-OM) during a 52-week, double-blind maintenance phase (Phase 4). Primary endpoint was time-to-impending relapse. Safety and tolerability were also assessed.

Results

710 patients entered Phase 2, 576 Phase 3 and 403 Phase 4 (ARI-OM=269, placebo-OM=134). The study was terminated early because efficacy was demonstrated by a pre-planned interim analysis. Time-to-impending relapse was significantly delayed with ARI-OM vs. placebo-OM (p< 0.0001, log-rank test). Discontinuations due to treatment-emergent adverse events (AEs) were: Phase 1, 3.8% (n=24/632); Phase 2, 3.0% (n=21/709); Phase 3, 4.9% (n=28/576); Phase 4, 7.1% (n=19/269). Most AEs were mild or moderate. Insomnia was the only AE >5% incidence in any phase. Headache, somnolence, and nausea had a peak first onset within the first 4 weeks of treatment. There were no unusual shifts in all phases in laboratory values, fasting metabolic parameters, weight, or objective scales of movement disorders.

Conclusions

ARI-OM significantly delayed time-to-impending relapse compared with placebo-OM and was well tolerated as maintenance treatment in schizophrenia1.

Type
Research Article
Copyright
Copyright © European Psychiatric Association 2012

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References

Kane, J., et al.J. Clin. Psychiatry 2012; 73: 6171–624Google Scholar
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