Innovations In Clinical Neuroscience

NOV-DEC 2017

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

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26 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 t= -4.44, df=434), compared to the placebo group (Figure 2, top). Treatment-related improvement in "insight and judgment" from baseline to Week 6 was significantly associated with improvement in depressive symptoms (regression slope=1.41, SE=0.28, p<0.001, t=5.00), neurocognitive performance (regression slope=0.42 , SE=0.12, p<0.001, t= 3.49), functional capacity (regression slope=3.31, SE=0.67, p<0.001, t=4.96) (Figure 3, top), and the rater-administered quality of well-being (regression slope=0.024, SE=0.008, p=0.004, t=2.93) in the acute study (Figure 4, top). At Month 6 of the double-blind, continuation study (Week 32), the flexible dose lurasidone 40 to 160mg/d group (LUR-LUR) showed significantly greater improvement on PANSS- item G12 "insight and judgment" from acute phase baseline, compared to the flexible-dose quetiapine XR 200 to 800mg/d group (QXR- QXR) (effect size=0.36, p=0.032, t=2.16, df=226) (Figure 2, bottom). At Week 32 (Month 6 of the continuation study), improvement in PANSS total score (effect size=0.55, p=0.001, t=3.32, df=226), PANSS positive subscale score (effect size=0.43, p=0.010, t=2.60, df=226), and PANSS negative subscale score (effect size=0.41, p=0.014, t=2.47, df=226) was significantly greater in the lurasidone 40 to 160mg/d group (LUR-LUR) compared to the quetiapine XR 200 to 800mg/d group (QXR-QXR). Improvement in "insight and judgment" from acute phase baseline significantly mediated reduction in PANSS total score (p<0.001), PANSS positive (p<0.001) and negative (p<0.001) subscale scores with lurasidone 40 to 160mg/d (LUR-LUR) and quetiapine XR 200 to 800mg/d (QXR-QXR) treatment. Treatment-related improvement in "insight and judgment" (PANSS-item G12 score) from acute phase baseline to Week 32 was significantly associated with improvement in depressive symptoms (regression slope= 0.40, SE= 0.20, p=0.05, t=1.95), neurocognitive performance (regression slope=0.29, SE=0.12, p=0.014, t=2.47), functional capacity (regression slope=2.05, SE=0.73, p=0.006, t=2.79, Figure 3, bottom), and the rater- administered quality of well-being (regression slope=0.02, SE=0.008, p=0.033, t=2.15, Figure 4, bottom) across treatment groups and study periods. These relationships between change in insight and change in functional capacity and depressive symptoms were not statistically significant when both PANSS-G12 item score and psychopathology (as assessed by PANSS total and subscale measures) were included in the same mixed linear model. The difference in change in "insight and judgment" for the LUR- LUR and QXR-QXR groups was not independent of overall change in psychopathology (as assessed by PANSS total and subscales). DISCUSSION In this post-hoc analysis involving patients with schizophrenia, lurasidone and quetiapine XR treatment groups demonstrated significant improvement in insight and judgment compared to placebo at the six-week study endpoint (assessed using the PANSS G12 item). Lack of insight and judgment was FIGURE 3. Longitudinal relationship between changes in insight and functional capacity from acute study baseline (mixed effects LDA model): ***P<0.001 (regression slope at Week 6), **p<0.01 (regression slope at Week 32). Positive and Negative Syndrome Scale (PANSS)-item G12 -- positive change scores represent improvement from baseline.

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