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Psych Congress  

Effects of Aripiprazole Lauroxil on Agitation and Hostility in Patients with Schizophrenia

Leslie Citrome, MD
Yangchun Du, PhD
Robert Risinger, MD
Srdjan Stankovic, MD, MSPH
Amy Claxton, PhD
Jacqueline Zummo, MPH, MBA
Anjana Bose, PhD
Bernard L. Silverman, MD
Elliot W. Elrich, MD
Alkermes, Inc.

Background: Post-hoc analyses were conducted on data from a large, placebo-controlled, 12-week study of aripiprazole lauroxil (AL) long-acting injectable to evaluate agitation and hostility in patients with schizophrenia. Methods: Randomized subjects (N=622) received AL 441mg, 882 mg, or placebo, once-monthly for 12-weeks. Changes from baseline were evaluated for the Positive and Negative Syndrome Scale (PANSS) Hostility item (P7), Excited Component (EC) score and, in the Personal and Social Performance scale (PSP) Disturbing and Aggressive behavior domain. Change in PANSS-EC was also analyzed in PANSS non-responders (<30% improvement). Results: Analyses demonstrated clinically meaningful and statistically significant improvements at Day 85. Subjects scoring >1 on Item P7 were 53.6%, 46.1% and 66.3% for AL 441 mg, 882 mg and placebo, respectively. Placebo-adjusted differences (mean±SE) in PANSS-EC score in all patients were -1.97±0.40 (p<0.001) and -2.37±0.40 (p<0.001) for AL 441 mg and 882 mg, respectively; in the subset of non-responders, -1.34±0.46 (p=0.004) and -2.15±0.45 (p<0.001) for AL 441 mg and 882 mg, respectively. Presence of aggressive behavior on PSP were 30.0% (p=0.006), 22.2% (p<0.001) and 44.1%, AL 441 mg, 882 mg or placebo. The most common adverse events (>5%) were akathisia, insomnia, headache and anxiety. Conclusions: AL was associated with a significant reduction in symptoms of hostility and agitation in both the overall population and, in the subset of PANSS non-responders. The numerically greater improvement seen in AL882 mg group may indicate potential benefit of higher dosing in some subjects

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