Aripiprazole Once-Monthly in the Treatment of Acute Psychotic Episodes in Schizophrenia

Abstract

BackgroundLong-acting injectable antipsychotics are treatment options for acute and long-term treatment of patients with schizophrenia. In a previously published 12-week randomized, double-blind, placebo-controlled clinical trial of patients with schizophrenia experiencing an acute psychotic episode, aripiprazole once-monthly 400 mg (AOM 400) produced significantly greater improvement than placebo on the primary endpoint, Positive and Negative Syndrome Scale (PANSS) total score at week 10.MethodsTo examine the efficacy of AOM 400 across a broader representation of schizophrenia symptoms, including agitation, a post hoc analysis of this trial was carried out to assess the change in PANSS Marder factor domains (positive symptoms, negative symptoms, disorganized thought, uncontrolled hostility/excitement, and anxiety/depression) and the PANSS excited component (equivalent to Marder factor domain uncontrolled hostility/excitement plus the tension item) by comparing differences in change from baseline between AOM 400 and placebo using a mixed model for repeated measures.ResultsThe differences between treatment and placebo for all factors were statistically significant, with improvements seen as early as week 1 or 2, and maintained through week 12. Thus, AOM 400, supplemented with oral aripiprazole in the first 2 weeks, showed significantly greater efficacy versus placebo in acutely ill patients with schizophrenia in all 5 Marder illness domains, as well as in agitation as conceptualized by the PANSS excited component score.ConclusionsThese findings indicate that AOM 400 is efficacious across the spectrum of schizophrenia symptoms in acutely ill patients, with implications for both short-term and, by extension, long-term patient outcomes.

Real-life assessment of aripiprazole monthly (Abilify Maintena) in schizophrenia: a Canadian naturalistic non-interventional prospective cohort study

“…These favourable clinical outcomes during the 12-month study were observed despite the fact that at the time of recruitment, patients were relatively stable, although only a small proportion were in full remission. This is in line with recently published studies showing AOM to be efficacious across the spectrum of schizophrenia symptoms [30] and also observed in studies conducted with other atypical antipsychotics [31]. This could also be related to the fact that LAI medication assures adherence as long as the patient is receiving the injection.…”

<p>Symptomatic stability with aripiprazole once-monthly: efficacy analyses from acute and long-term studies</p>

“…AOM 400 was significantly more effective vs placebo in improving PANSS total score, positive and negative subscale scores, and CGI-S score from baseline, with significant differences achieved at every post-baseline timepoint. The present results are confirmed by an analysis showing a significant benefit of AOM 400 across the range of PANSS Marder factors 32. Our analysis of efficacy results in Study 291 stratified by patient age (adults aged ≤35 years or >35 years) provides some insights on the effect of age on the pattern of symptom improvement after initiation of AOM 400.…”