105. Efficacy of Cariprazine in Patients With Schizophrenia Based on Stage of Illness

Abstract

Background: Cariprazine (CAR) is a D3/D2 receptor partial agonist antipsy‐chotic approved for treatment of adults with acute exacerbation of schizophrenia. Many patients with schizophrenia display a progressive worsening of symptomatology, a process that has the potential to impede treatment response. These post hoc analyses were performed to evaluate CAR effcacy in subsets of patients at different stages of disease progression. Methods: Data were pooled from 3 randomized, 6‐week, double‐blind, placebo (PBO)‐controlled Phase II/III trials of CAR effcacy and safety in patients with schizophrenia (NCT01104766, NCT01104779, NCT00694707). For this post hoc analysis, data were grouped according to number of previous episodes (<5, 5‐10, >10), duration of schizophrenia in years (≤5.1, 5.2‐13.4, >13.4), or number of previous psychiatric hos‐pitalizations (≤2, 3‐6, >6). Effcacy outcomes were change from baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) total score, PANSS Positive and Negative subscales, and Clinical Global Impression of Severity scale (CGI‐S); data were analyzed using a mixed‐effects model for repeated measures. Results: At all stages of illness, patients treated with CAR (n = 1024) showed a signifcantly greater improvement on PANSS and CGI‐S total scores than did those treated with PBO (n = 442). Compared with PBO, CAR signif‐cantly reduced mean PANSS total score in patients regardless of number of previous episodes (<5: least squares mean difference [LSMD]‐8.0, P 10: LSMD‐9.2, P =.0001), duration of schizophrenia (≤5.1 years: LSMD‐7.6, P =.0002; 5.2‐13.4 years: LSMD‐8.5, P 13.4 years: LSMD‐7.6, P =.0003), or num‐ber of previous psychiatric hospitalizations (0‐2: LSMD‐5.6, P =.0030; 3‐6: LSMD‐9.7, P 6: LSMD‐9.6, P <5: LSMD‐0.4, P =.0005; 5‐10: LSMD‐0.2, P =.0385; >10: LSMD‐0.7, P 13.4 years: LSMD‐0.3, P =.0017), or number of previous psychiatric hospitalizations (0‐2: LSMD‐0.3, P =.0133; 3‐6: LSMD‐0.4, P 6: LSMD‐0.6, P