Abstract
BACKGROUND: Cariprazine, a potent dopamine D(3)-preferring D(3)/D(2) receptor partial agonist, has demonstrated benefits on negative symptoms among patients with schizophrenia. Secondary endpoint and post-hoc analyses have also suggested a benefit of cariprazine on quality of life (QoL) and attention. METHODS: Data for this post-hoc analysis were pooled from two 6-week, placebo-controlled phase 3 trials evaluating cariprazine among patients with acute exacerbations of schizophrenia. One study included an aripiprazole active-control arm for assay sensitivity.Two populations were analyzed: pooled intention-to-treat (ITT) population (N = 1043), and the pooled subgroup with predominant negative symptoms (PNS, n = 215), as defined by the Positive and Negative Syndrome Scale (PANSS) subscale and item cut-off criteria at baseline. Analyses of interest were: Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) total score; Cognitive Drug Research (CDR) power of attention (PoA), and continuity of attention (CoA). RESULTS: Among study completers, cariprazine and aripiprazole were associated with significant SQLS-R4 improvements in the ITT and PNS populations. Differences in CDR-PoA scores were significant for cariprazine vs. placebo in the ITT and PNS populations, but not for aripiprazole in the ITT or PNS analyses. Differences in CDR-CoA scores were significant for cariprazine vs. placebo in the ITT and PNS analyses; and was significant for aripiprazole vs. placebo in the PNS analysis, but not in the ITT analysis. CONCLUSIONS: This post-hoc analysis suggests that cariprazine may be associated with beneficial effects on measures of attention and QoL among patients with schizophrenia, and these effects could be more pronounced among individuals with PNS.