THE EFFECT OF LURASIDONE ON PANSS MARDER 5 FACTORS AND INDIVIDUAL ITEMS IN PATIENTS WITH ACUTE SCHIZOPHRENIA: A POST- HOC ANALYSIS OF RANDOMIZED, PLACEBO-CONTROLLED TRIAL (JEWEL STUDY)

Abstract Background Lurasidone is a second-generation antipsychotic approved for the treatment of people with schizophrenia in Japan, the United States, European Union, and many other countries worldwide. It possesses high affinity for D2, 5-HT7, 5-HT2A and 5-HT1A receptors and no affinity for H1 and M1 receptors. Aims & Objectives The objective of this post-hoc analysis was to evaluate the effect of lurasidone 40mg/day (LUR) on PANSS Marder 5 factors and individual items in people with acute schizophrenia. Method A post-hoc analysis was conducted using the data from patients in a phase 3 study of lurasidone (a 6-week, randomized, placebo-controlled trial; JEWEL study). The study was approved by ethical committees in each country, complied with ICH-GCP guidelines, and written informed consent from all subjects was obtained. Change from baseline in Positive and Negative Syndrome Scale (PANSS) Marder 5 factor and 30 individual item scores between LUR and placebo (PBO) at each assessment point were compared using a mixed-effects model for repeated measures. Results Mean change from baseline of all Marder 5 factor scores in LUR at week 6 were statistically greater (p<0.05) than one in PBO (positive symptoms, negative symptoms, disorganized thought, hostility/excitement and anxiety/depression [LS mean] were -6.6, -3.8, -3.7, -2.0 and -3.4 in LUR and -4.3, -2.9, -2.5, -1.2 and -2.5 in PBO, respectively). Changes in 4 factors other than negative symptoms in LUR were statistically greater than one in PBO from week 2. Among PANSS 30 individual items that consist Marder factors, P1, P2, P3, P6, P7, N5, G1, G2, G4, G9, G11, G14, G15 and G16 showed statistically greater change from baseline at week 6 in LUR compared to PBO. Discussion & Conclusion In this post-hoc analysis, lurasidone showed the effect on various psychotic symptoms in JEWEL study, suggesting lurasidone is considered to be an effective option for acute schizophrenia.