Effect of patient age on treatment response in a study of the acute exacerbation of psychosis in schizophrenia

Steven D. Targum, Robert Risinger, Yangchun Du, J. Cara Pendergrass, Hassan H. Jamal, Bernard. L. Silverman

Younger patients with schizophrenia have most likely experienced fewer adverse consequences of the illness than older patients who may have experienced a lifetime of treatment as well as socio-economic problems as a consequence of the illness. There is limited information regarding differential efficacy of long-acting injectable (LAI) antipsychotic medications across the age span in patients with schizophrenia. We conducted a post hoc age and gender analysis of treatment response to aripiprazole lauroxil (AL; ARISTADA®; Alkermes, Inc.), in a 12-week, double-blind, placebo-controlled, multinational, Phase 3 study evaluating two doses of AL (441mg and 882mg) versus placebo in adult patients experiencing an acute exacerbation of schizophrenia within the previous 2months. We examined change in the total Positive and Negative Syndrome Scale (PANSS) scores from baseline using analysis of covariance and categorical treatment response (defined as ≥30% total PANSS score improvement from baseline) in the following age groups: <30, 30-39, 40-49, and 50-69years old. Age and gender did not moderate the treatment response in this study. Both AL 441mg and AL 882mg showed an early and significant improvement of the mean total PANSS scores and categorical treatment responses compared to placebo in all four age groups, including younger patients regardless of gender that was sustained over the 85-day treatment period.