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Psych Congress  

Day-to-Day and Social Functioning of Patients With Negative Symptoms of Schizophrenia: Post-Hoc Analyses of a Phase 3 Clinical Trial With Cariprazine Monotherapy and Risperidone

Authors  
Ágota Barabássy, MD; István Laszlovszky, PharmD, PhD; Balázs Szatmári, MD; Erzsébet Szalai, MD; Judit Harsányi, PharmD; Irma Saliu, PharmD; György Németh, MD, PhD
Sponsor  
Allergan

This poster was presented at the 30th annual  Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.

Introduction: Negative symptoms can substantially impact day-to-day functioning of patients with schizophrenia, including the ability to perform daily activities and maintain personal relationships. This was a post hoc analysis to evaluate day-to-day and social functioning of patients with predominant negative symptoms (PNS) of schizophrenia treated with cariprazine versus risperidone.

Methods: Data from a 26-week, randomized, double-blind, active-controlled study in patients with schizophrenia and PNS were analyzed (EudraCT 2012-005485-36). Patients with PNS (Positive and Negative Syndrome Scale [PANSS] factor score for negative symptoms _24) were randomized to cariprazine 4.5 mg/d (n=230) or risperidone 4.0 mg/d (n=231). Mean change from baseline to week 26 on the Personal and Social Performance (PSP) scale and PANSS prosocial subscale (P3, P6, N2, N4, N7, G16) were analyzed.

Results: The least squares mean difference (LSMD [95% CI]) in change from baseline to week 26 was statistically significant for cariprazine versus risperidone on the PSP (+4.6 [2.7, 6.6]; P<.001; effect size=0.48); the PSP subdomains of self-care (-0.2 [ 0.3; 0.1]; P=.004), personal and social relationships (-0.2 [-0.4; -0.1]; P<.001), and socially useful activities (-0.4 [-0.5; -0.2]; P<.001); and on the PANSS prosocial subscale (-0.8 [-1.41, -0.16]; P=.014). Significantly more patients treated with cariprazine than risperidone improved >10 points on the PSP (odds ratio [OR]=2.1 [95% CI: 1.4, 3.3]; P=.001) or shifted to a higher functioning category (OR=2.2 [1.4, 3.4]; P<.001).

Conclusion: In this post hoc analysis, treatment with cariprazine was associated with a clinically relevant improvement in patient functioning and social competence compared with risperidone.

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