Cariprazine was tested in three pivotal, multinational, randomised, double-blind, placebo-controlled trials in non-elderly adults (18-60) hospitalised for an acute exacerbation of schizophrenia (mean duration of disease 11.4 years). Six weeks of treatment with cariprazine demonstrated statistically superior improvements in the primary (PANSS total score) and secondary (CGI-S) efficacy outcomes vs. placebo over its entire dose range studied. The onset of significant superiority vs. the placebo response in PANSS total scores was generally observed as early as week 2 for the lower cariprazine doses (1.5-3.0 mg/day and already at week 1 for the higher doses (4.5 mg/day and above).

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