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Psych Congress  

Efficacy of Cariprazine in Patients With Predominant Negative Symptoms of Schizophrenia: Post Hoc Analysis of PANSS Data, Marder Factors, and Cognition

Authors  
Stephen Marder, MD
István Laszlovszky, PharmD, PhD
Erzsébet Szalai, MD
Balázs Szatmári, MD
Judit Harsányi, MD
Ágota Barabássy, MD
Marc Debelle, MD
Suresh Durgam, MD
István Bitter, MD
György Németh, MD
Sponsor  
Allergan, Inc., and Gedeon Richter Plc

This poster was presented at the 29th Annual U.S. Psychiatric & Mental Health Congress, held October 21-24, 2016, in San Antonio, Texas.

Introduction: In a 26-week Phase III, double-blind, active-controlled trial in patients with predominant negative symptoms of schizophrenia, significantly greater improvements in negative symptoms and functioning were seen for cariprazine- versus risperidone-treated patients. Primary and post hoc Positive and Negative Syndrome Scale (PANSS) data were further evaluated.

Methods: Subjects with schizophrenia and PANSS factor score for negative symptoms (PANSS-FSNS) ≥24 and no pseudospecific factors (eg, extrapyramidal and depressive symptoms) were randomized (1:1): cariprazine 4.5 mg/d (n=230; dose range: 3-6 mg/d) or risperidone 4 mg/d (n=231; dose range: 3-6 mg/d). Primary efficacy: change from baseline (CFB) to week 26 in PANSS-FSNS; secondary efficacy (functional improvement): CFB on the Personal and Social Performance Scale (PSP); additional efficacy: CFB in PANSS factor score for positive symptoms (PANSS-FSPS). PANSS-derived post hoc analyses: CFB in single items, Marder factors (disorganized thought, uncontrolled hostility/excitement, anxiety/depression), and a cognitive subscale (P2, N5, N7, G10, and G11).

Results: CFB was significantly greater for cariprazine versus risperidone in PANSS-FSNS (LSMD=-1.46; P=.002) and PSP (LSMD= 4.63; P<.001). PANSS-FSPS scores were low at baseline; they remained stable and similar between groups. PANSS Marder factor for disorganized thought was on the level of significance for cariprazine (LSMD= -0.63; P=.05); anxiety/depression and uncontrolled hostility/excitement factors were not significantly different. There was significant improvement on the cognitive subscale favoring cariprazine (LSMD=-0.53; P=.028).

Conclusion: In patients with predominant negative symptoms of schizophrenia, significant improvement in negative symptoms and functioning was seen for cariprazine versus risperidone; cognitive improvement was also significantly different in favor of cariprazine.

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