VALUABLE INTERACTION WITH COGNITIVE REMEDIATION AND OPTIMAL ANTIPSYCHOTICS FOR RECOVERY IN SCHIZOPHRENIA (VICTORY-S): STUDY PROTOCOL FOR AN INTERVENTIONAL, OPEN-LABEL, RATER- BLINDED, RANDOMIZED COMPARISON OF COMBINED TREATMENT WITH COGNITIVE REMEDIA

Abstract Background Cognitive impairment, a core feature of schizophrenia, is associated with poor functional outcomes. Available interventions include both pharmacotherapy and psychosocial treatment. However, each of these interventions, when used alone, have often inadequate effect sizes. Aims & Objectives This study aims to compare the effects of lurasidone combined with cognitive remediation (the Neuropsychological Educational Approach to Remediation [NEAR]) and paliperidone combined with NEAR on cognitive function in patients with schizophrenia. Methods The valuable interaction with cognitive remediation and optimal antipsychotics for recovery in schizophrenia (VICTORY-S) study is a multicenter, interventional, open-label, rater-blinded, randomized comparison study, comparing the effect of lurasidone plus cognitive remediation with that of paliperidone plus cognitive remediation in patients with schizophrenia. The NEAR will be used for cognitive remediation. Eligible patients will be randomized 1:1 to receive lurasidone or paliperidone combined with NEAR (6 weeks antipsychotic alone followed by 24 weeks combination antipsychotic plus NEAR). The primary endpoint is the change from baseline in the tablet-based Brief Assessment of Cognition in Schizophrenia composite T-score at the end of the 24-week NEAR combination treatment period. Secondary endpoints will include change from baseline in various measures of social function, positive and negative symptoms, depression, defeatist beliefs, and quality of life at the end of the 24- week NEAR combination treatment period. Furthermore, change from the end of the 6-week antipsychotic alone period to the end of the 24-week NEAR combination treatment period will be assessed for all endpoints. Safety will also be evaluated. (Japan Registry of Clinical Trials ID is jRCTs031200338) Results This study is currently recruiting participants. Discussion & Conclusion: Achievement of adequate cognitive function is central to supporting social function, which is one of the key treatment goals for patients with schizophrenia. A previous study investigated the combined effect of lurasidone and cognitive remediation in patients with schizophrenia. However, cognitive function had recovered by the start of cognitive remediation and there was no antipsychotic control. We think that this study will fill in the gaps of the previous study and provide useful information to clinicians regarding treatment decisions for patients with schizophrenia.