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Psych Congress  

Effectiveness of aripiprazole once-monthly in two double-blind, placebo- and active-controlled studies for the treatment of schizophrenia

Authors  
Ross Baker, PhD, MBA. Karina Hansen, MSc, PhD. Timothy Peters-Strickland, MD. Carlos Forray, MD. Anna G. Nylander, PhD. Maud Beillat, MSc. Christophe Sapin, MSc (stat) MSc (econ). Joan Zhao, PhD. Peter Hertel, PhD. Jean-Yves Loze, MD, MSc.
Sponsor  
Otsuka Pharmaceutical Development and Commercialization, Inc. and H. Lundbeck A/S

Objective: To evaluate the effectiveness of aripiprazole once-monthly (ARI-OM) 400mg (ARI-OM-400) versus a sub-therapeutic dose of ARI-OM 50mg (ARI-OM-50), oral aripiprazole (ARI), and placebo, in two trials of stable patients with schizophrenia.
Methods: These two studies were double-blind, placebo- or active-controlled assessing the efficacy and safety of ARI-OM. Detailed study designs have been reported previously (1,2). Results are reported for the double-blind, randomized phase of each study. ARI-OM is an extended-release injectable suspension given at 400mg in the gluteal muscle. The Investigator's Assessment Questionnaire (IAQ) was used, a 10-item instrument designed to assess relative effectiveness (efficacy, safety and tolerability) of antipsychotic medications in patients with schizophrenia (3). Statistical analysis used analysis of covariance with last observation carried forward. 
Results: 403 patients were randomized to ARI-OM-400 (n=269) or placebo (n=134) in the first (246) trial. IAQ scores at endpoint significantly worsened with placebo (+3.8) vs. ARI-OM (+1.3; p<0.0001). 662 patients were randomized to: ARI-OM-400 (n=265); ARI (n=266); or ARI-OM-50 (n=131) in the second study (247). IAQ scores in the sub-therapeutic ARI-OM-50 arm also significantly worsened (+2.04) vs. ARI-OM-400 (+0.08; p=0.002). IAQ scores with ARI were similar to ARI-OM (+0.35).
Conclusion: Treatment effectiveness, assessed by IAQ, was maintained with ARI-OM in both studies but deteriorated in patients randomized to either sub-therapeutic doses or to placebo. Thus, adequately dosed antipsychotic therapy maintains effectiveness in the long-term management of patients with schizophrenia. 

(1)Kane et al. J Clin Psychiatry 2012;73:617–624.
(2)Fleischhacker et al. Poster presented at ACNP, 2012.
(3)Tandon et al. Psy Res. 2005;136:211-21  

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