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 - 08/07/17
Résumé |
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 4.5mg/d or risperidone 4mg/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.
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Vol 41 - N° S
P. S270 - avril 2017 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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