To support the efficacy of cariprazine in maintaining the established 6-week benefits in patients with an acute exacerbation of schizophrenia, a relapse prevention study was conducted in patients whose disease remained stable during a 20-week open-label cariprazine therapy. In this phase III, multinational, randomised, double-blind, placebo-controlled trial of up to 72-week treatment in non-elderly adults (18-60, N=200) with stable schizophrenia, cariprazine 3-9 mg/day was shown to cut the risk of exacerbation of psychotic symptoms by more than half vs. placebo (i.e., the withdrawal group). The risk of relapse in the approved dose range of 3-6 mg/day was reduced by 60% (N=102, 95%CI: 18-80%).

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