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.