Abstract
Evaluation of a new five-factor dimensional model of schizophrenia in recent revisions of classifications of mental disorders (DSM-5 and ICD-11) dictates the need to use this approach in conducting a comprehensive assessment of the effectiveness of new antipsychotic agents, including ethnically homogeneous populations of patients. Post-hoc analysis of pooled data from two randomized, double-blind, placebo-controlled, 6-week clinical studies (RCTs) of lurasidone (fixed doses, 40, 80, 120 or 160 mg/d) in patients experiencing an acute exacerbation of schizophrenia. Changes in PANSS total score, CGI-S score and five established PANSS factors were assessed using mixed-model repeated measures analysis. Lurasidone (n=162, dose groups pooled) compared with placebo (n=68), significantly improved the PANSS total score at Week 6 (-23.0 vs. -10.5; p<0.001; effect size 0.82) as well as all PANSS factor scores: positive symptoms (-8.5 vs. -4.2; p<0.001; effect size 0.88), negative symptoms (-4.4 vs. -2.8; p=0.011, effect size 0.44), disorganized thoughts (-4.4 vs. -2.1; p<0.001; effect size 0.70), hostility/excitement (-2.7 vs. -0.7; p<0.001; effect size 0.66), and depression/anxiety (-3.5 vs. -2.2; p=0.002; effect size 0.53). Lurasidone demonstrated significant improvement for both PANSS total score and each of the five PANSS factor scores, indicating effectiveness across the broad spectrum of schizophrenia symptoms. Effect size for both PANSS total score and each of the five PANSS factor scores for the local population was higher than for the wider population, which included patients from various countries.
Published Version
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