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Psych Congress  

Aripiprazole Once-Monthly for the Treatment of Schizophrenia: A Double-Blind, Randomized, Noninferiority Study Versus Oral Aripiprazole

Anna Eramo, MD. W. Wolfgang Fleischhacker, MD. Raymond Sanchez, MD. Pamela P. Perry, MS. Na Jin, MS. Timothy Peters-Strickland, MD. Ross A. Baker, PhD, MBA. Robert D. McQuade, PhD. William H. Carson, MD. John M. Kane, MD.
Otsuka Pharmaceutical Development & Commercialization, Inc., and H. Lundbeck A/S

Objective: A double-blind, randomized, noninferiority study (NCT00706654) evaluated aripiprazole once-monthly (AOM)—an extended-release injectable suspension—vs oral aripiprazole (ARI) for the treatment of schizophrenia.
Methods: Patients required chronic antipsychotic treatment; those not receiving ARI were cross-titrated to ARI (4–6 weeks; Phase 1). Patients then entered an 8–28-week stabilization phase (Phase 2) with ARI 10–30 mg/d. Patients already receiving ARI entered at Phase 2. Patients meeting stability criteria (8 consecutive weeks) were randomized (2:2:1) to 38 weeks of double-blind treatment (Phase 3) with AOM 400 mg (AOM-400), ARI 10–30 mg/d, or AOM 50 mg (AOM-50; for assay sensitivity). Primary endpoint: proportion of patients with estimated relapse by Week 26 (noninferiority of AOM-400 vs ARI).
Results: Week 26 estimated relapse rates (N=662 randomized [Phase 3]) were 7.1% for AOM-400, 21.8% for AOM-50, and 7.8% for ARI; the difference between AOM-400 and ARI (–0.6%; 95% confidence interval: –5.3, 4.0) excluded the predefined noninferiority margin (11.5%). Superiority vs AOM-50 was achieved for AOM-400 (P<0.001) and ARI (P=0.0012). All-cause discontinuation with AOM-400 was superior to ARI and AOM-50. Kaplan-Meier time to discontinuation favored AOM-400 vs ARI (P<0.05) and AOM-50 (P<0.0001). Insomnia, akathisia, headache, weight decrease, or weight increase were reported by 9–12% of AOM-400 patients. Mean changes in weight were similar between groups (range, –1.1 to 0.7 kg). No relevant changes in metabolic parameters or extrapyramidal symptoms occurred. 
Conclusion: AOM-400 was noninferior to ARI in estimated relapse rate, and superior to both ARI and AOM-50 in reducing all-cause discontinuations.  

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