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

Abstract

Introduction

Negative symptoms have substantial impact on day-to-day functioning of patients with schizophrenia affecting their ability to perform activities of daily living and to maintain personal relationships.

Objective

To present post hoc data on day-to-day and social functioning of patients with predominant negative symptom (PNS) of schizophrenia, treated with cariprazine versus risperidone.

Methods

Data from 26 weeks, phase 3, randomized, double-blind, active-controlled study in PNS patients were analyzed (EudraCT 2012-005485-36). Subjects with PNS (PANSS factor score for negative symptoms ≥24) were randomized to cariprazine 4.5 mg/d or risperidone 4 mg/d. Change from baseline to end of treatment on the personal and social performance scale (PSP) and PANSS prosocial subscale (P3, P6, N2, N4, N7, G16) was analyzed.

Results

Significantly greater improvements were seen with cariprazine compared to risperidone in the change from baseline to end of treatment on the PSP (LSMD + 4.632 [2.71, 6.56]; P < 0.001) from week 10 onwards (effect size 0.48); in the PSP subdomains of self-care (LSMD −0.2 [−0.3; −0.1]; P = 0.004), personal and social relationships (LSMD −0.2 [−0.4;−0.1]; P < 0.001) and socially useful activities (LSMD −0.4 [−0.5; −0.2]; P < 0.001); in the number of patients who improved at least 10 points on the PSP (OR 2.1; P = 0.001) or shifted to a higher category (OR 2.2; P = 0.001); and on the PANSS prosocial subscale (LSMD −0.8 [−1.41, −0.16]; P = 0.014).

Conclusion

Post hoc evaluation of this study showed that cariprazine treatment is associated with a clinically relevant improvement in patient functioning and social competence compared to risperidone.

Disclosure of interest

Employee of Gedeon Richter Plc.