Innovations In Clinical Neuroscience

NOV-DEC 2017

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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25 ICNS INNOVATIONS IN CLINICAL NEUROSCIENCE November-December 2017 • Volume 14 • Number 11–12 O R I G I N A L R E S E A R C H with a primary diagnosis of schizophrenia who had recently been hospitalized for an acute exacerbation of psychotic symptoms, impaired insight was found in 287 (59.5%) subjects (PANSS-item G12 item score of at least 4 at acute study baseline). Most patients were male (68.3%) and Caucasian (57.1%), with mean age 37.2 years. Similar clinical characteristics were observed for patients randomized to lurasidone or quetiapine XR at baseline of the randomized, double-blind, acute phase (N=482, overall baseline PANSS score 97.4, G12 item score 3.7, cognitive composite z-score 2.86) and for the cohort who continued throughout the six- month, double-blind extension phase (N=292, baseline PANSS score 97.6, G12 item score 3.8, cognitive composite z-score -2.97). Symptom severity at acute study baseline was similar for the LUR-LUR group (PANSS 97.7, G12 item score 3.78) and the QXR-QXR group (baseline PANSS score 97.9, G12 item score 3.89). In addition, symptom severity at Week 6 (end of acute phase) was comparable for the LUR-LUR group (PANSS 66.7, G12 item score 2.85) and the QXR- QXR group (PANSS 67.8, G12 item score 2.96). Cross-sectional analysis of acute phase baseline data. In acute phase baseline analyses of 482 patients, more severe insight and judgment impairment (higher PANSS G12 item score) was associated with lower cognitive performance (p<0.001, regression slope= -0.54, standard error [SE]=0.16, t= -3.42, df=420), lower functional capacity (as assessed by the University of California, San Diego Performance-Based Skills Assessment- brief [UPSA-B] score) (regression slope= -2.85, SE= 0.93, p=0.0023, t= -3.06, df=433) and greater uncooperativeness (as assessed by PANSS G8 item) (regression slope=0.29, SE=0.05, p<0.001, t= 6.17, df=435). Higher scores on item G12 were significantly associated with higher probability of failure for completing cognitive testing and/or obtaining valid scores at acute baseline visit (odds ratio [OR]=1.34, p=0.002, chi-square [c 2 ]=9.385). Longitudinal analysis of outcomes. Improvement in "insight and judgment" from acute phase baseline to Week 6 was significantly greater for the lurasidone groups (effect size=0.61 for 160mg/d vs. placebo, p<0.001, t= -4.02, df=434; effect size=0.58 for 80mg/d vs. placebo, p<0.001, t= -3.71, df=434) and the quetiapine XR 600mg/d group (effect size=0.67 vs. placebo, p<0.001, FIGURE 2. Change from acute study baseline in Positive and Negative Syndrome Scale (PANSS)-item G12 "lack of judgment and insight"—mixed model repeated measures analysis (MMRM, intent-to-treat population); treatment comparisons with placebo (PBO) at Week 6: *** < 0.001 for lurasidone 80mg/d (LUR80), lurasidone 160mg/d (LUR160), and quetiapine extended release (XR) 600mg/d (QXR); treatment comparisons between flexible-dose lurasidone 40–160mg/d (the lurasidone-to-lurasidone cohort) (LUR-LUR) or flexible dose quetiapine XR 200-800 mg/d (the quetiapine XR-to-quetiapine XR cohort) (QXR-QXR) at Month 6 of extension study (Week 32): *p<0.05

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