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Psych Congress  

Treatment Response by Age Group in a Phase 3 study of Aripiprazole Lauroxil for Acute Exacerbation of Schizophrenia

Steven Targum, MD
Robert Risinger, MD
Yangchun Du, PhD
Hassan Jamal, MSc
Bernard Silverman, MD
Alkermes, Inc

This poster was presented at the 29th Annual U.S. Psychiatric & Mental Health Congress, held October 21-24, 2016, in San Antonio, Texas.

Background We conducted an age analysis of treatment outcome in a 12-week study evaluating 441 mg and 882 mg doses of aripiprazole lauroxil (AL; ARISTADA®, Alkermes, Inc.), a long-acting injectable antipsychotic, versus placebo.

Methods Evaluations in the age groups: 18-29 (n=128), 30-39 (n=170), 40-49 (n=165), and 50-69 (n=133) years included mean change in total positive and negative syndrome scale (PANSS) scores (using ANCOVA) and response (defined as ≥30% improvement of total PANSS from baseline).

Results PANSS scores decreased in AL-treated age groups over all study time-points. By ascending age group, the least squares mean difference (standard error) in PANSS score changes from baseline for the placebo, 441 mg and 882 mg arms, respectively, were -9.2 (2.60), -20.3 (3.13) and -19.1 (2.76); -10.0 (2.81), -19.8 (2.46) and -19.2 (2.60); -8.1 (2.48), -20.4 (2.19) and -21.0 (2.23); and -4.9 (2.82), -14.9 (3.21) and -20.1 (3.00). Response for the placebo, 441 mg and 882 mg arms was achieved by 20%, 35% and 41% in the 18-29 year group; 18%, 39% and 28% in the 30-39 year group; 19%, 35% and 33% in the 40-49 year group; and 16%, 32% and 40% in the 50-69 year group. Akathisia was the most common adverse event (frequency ≥5%) that occurred 11.6%, 11.5% and 4.3%, in the 441 mg, 882 mg and placebo arms, respectively.

Conclusion While limited by its post hoc nature, this analysis supports the efficacy of both doses of AL across all 4 adult age groups.

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