The aim of this study was to evaluate the safety and tolerability of aripiprazole once-monthly (ARI-OM) for the maintenance treatment of schizophrenia. This long-term, pivotal study had four phases: oral conversion (phase 1, 4–6 weeks); oral stabilization (phase 2, 4–12 weeks); ARI-OM stabilization with coadministration of oral aripiprazole in the first 2 weeks (phase 3, 12–36 weeks); and a 52-week, randomized [phase 4, ARI-OM vs. placebo (2 : 1)], double-blind, maintenance phase. Safety was assessed across study phases by the time of first onset of adverse events, as were objective measures of extrapyramidal symptoms, fasting metabolic parameters, and body weight. Patient enrollment was phase 1=633; phase 2=710, of whom 210 entered phase 2 directly; phase 3=576; and phase 4=403 (ARI-OM, n=269; placebo, n=134). Adverse events (>5%) in any phase were insomnia, headache, anxiety, akathisia, increase in weight, injection-site pain, and tremor. Headache, somnolence, and nausea had a peak first onset within 4 weeks of treatment initiation. The incidence of extrapyramidal symptoms was similar in all phases. There were no unexpected changes in weight or shifts in fasting metabolic parameters across all study phases. ARI-OM had a safety and tolerability profile comparable with oral aripiprazole in maintenance treatment of schizophrenia.
aDepartment of Psychiatry and Psychotherapy, Division of Biological Psychiatry, Medical University Innsbruck, Innsbruck, Austria
bOtsuka Pharmaceutical Development Commercialization Inc., Princeton, New Jersey
cOtsuka Pharmaceutical Development Commercialization Inc., Rockville, Maryland
dThe Zucker Hillside Hospital and the Hofstra North Shore-LIJ School of Medicine, Hempstead, New York, USA
Clinical trial registration: Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia (ASPIRE). ID number: NCT00705783. Registry: clinicaltrials.gov.
Correspondence to W. Wolfgang Fleischhacker, MD, Department of Psychiatry and Psychotherapy, Division of Biological Psychiatry, Medical University Innsbruck, Anichstrasse 35, A-6020 Innsbruck, Austria Tel: +43 512 504 23669; fax: +43 512 504 25267; e-mail: email@example.com
Received October 19, 2012
Accepted March 11, 2013