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

• Published in: Schizophrenia bulletin 2017-03, Vol.43 (suppl_1), p.S55-S55
• Main Authors: Mofsen, Ricky, Cheng, Cheng-Tao, Németh, György, Barabássy, Ágota, Earley, Willie
• Format: Article
• Language: English
• Subjects: Abstracts
• ISSN: 0586-7614; 1745-1701
• DOI: 10.1093/schbul/sbx021.143

Background: Cariprazine (CAR) is a D3/D2 receptor partial agonist antipsychotic 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 efficacy 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 efficacy and safety in patients with schizophrenia (NCT01104766, NCT01104779, NCT00694707). For this post hoc analysis, data were grouped according to number of previous episodes (10), duration of schizophrenia in years (≤5.1, 5.2–13.4, >13.4), or number of previous psychiatric hospitalizations (≤2, 3–6, >6). Efficacy 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 significantly greater improvement on PANSS and CGI-S total scores than did those treated with PBO (n = 442). Compared with PBO, CAR significantly reduced mean PANSS total score in patients regardless of number of previous episodes (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 < .0001; >13.4 years: LSMD −7.6, P  = .0003), or number of previous psychiatric hospitalizations (0–2: LSMD −5.6, P  = .0030; 3–6: LSMD −9.7, P < .0001; >6: LSMD −9.6, P < .0001). CAR also significantly reduced mean CGI-S overall score relative to PBO in patients regardless of number of previous episodes (10: LSMD −0.7, P < .0001), duration of schizophrenia (≤5.1 years: LSMD −0.3, P  = .0041; 5.2–13.4 years: LSMD −0.5, P < .0001; >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 < .0001; >6: LSMD −0.6, P < .0001). Similar results were observed on the PANSS Positive and Negative subscales. Conclusion: Cariprazine was efficacious in the overall adult population. When stratifi