Valuable interaction with cognitive remediation and optimal antipsychotics for recovery in schizophrenia (VICTORY-S): study protocol for an interventional, open-label, randomized comparison of combined treatment with cognitive remediation and lurasidone or paliperidone

Ryotaro Kubota; Satoru Ikezawa; Hideki Oi; Mari S Oba; Shoki Izumi; Ryoko Tsuno; Leona Adachi; Mako Miwa; Shunji Toya; Yohei Nishizato; Daisuke Haga; Tatsuro Iwane; Kazuyuki Nakagome

doi:10.3389/fpsyt.2023.1331356

Valuable interaction with cognitive remediation and optimal antipsychotics for recovery in schizophrenia (VICTORY-S): study protocol for an interventional, open-label, randomized comparison of combined treatment with cognitive remediation and lurasidone or paliperidone

Front Psychiatry. 2024 Feb 6:14:1331356. doi: 10.3389/fpsyt.2023.1331356. eCollection 2023.

Authors

Ryotaro Kubota¹, Satoru Ikezawa^{2

3}, Hideki Oi⁴, Mari S Oba⁴, Shoki Izumi⁴, Ryoko Tsuno⁴, Leona Adachi², Mako Miwa², Shunji Toya⁵, Yohei Nishizato⁵, Daisuke Haga⁶, Tatsuro Iwane⁷, Kazuyuki Nakagome²

Affiliations

¹ Department of Forensic Psychiatry, National Center of Neurology and Psychiatry Hospital, Tokyo, Japan.
² Department of Psychiatry, National Center of Neurology and Psychiatry Hospital, Tokyo, Japan.
³ Department of Psychiatry, International University of Health and Welfare Mita Hospital, Tokyo, Japan.
⁴ Department of Clinical Data Science, National Center of Neurology and Psychiatry, Tokyo, Japan.
⁵ CNS Group, Medical Science, Sumitomo Pharma Co., Ltd., Tokyo, Japan.
⁶ One More Job Training Institution, Osaka, Japan.
⁷ Kyoto Prefectural Rakunan Hospital, Kyoto, Japan.

Abstract

Background: Cognitive impairment, a core feature of schizophrenia, is associated with poor outcomes. Pharmacotherapy and psychosocial treatment, when used alone, have inadequate effect sizes for cognitive impairment, leading to recent interest in combination interventions. A previous study examined the additive effect of cognitive remediation on lurasidone in patients with schizophrenia, which was negative. Although improvement in cognitive function was suggested for lurasidone, it was inconclusive because there was no antipsychotic control in the study. To clarify whether lurasidone has a meaningful impact on cognitive function in combination with cognitive remediation, we use paliperidone as a control antipsychotic in this study. We hypothesize that combination with lurasidone will improve cognitive and social function to a greater extent than paliperidone.

Methods: The valuable interaction with cognitive remediation and optimal antipsychotics for recovery in schizophrenia study is a multicenter, interventional, open-label, rater-blind, randomized comparison study, comparing the effect of lurasidone plus cognitive remediation with that of paliperidone plus cognitive remediation in patients with schizophrenia. The Neuropsychological Educational Approach to Remediation (NEAR) is 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 NEAR combination treatment period. Secondary endpoints will include change from baseline in social function, schizophrenia symptoms, and quality of life at the end of the NEAR combination treatment period. Furthermore, change from baseline to the end of the pharmacotherapy period and change from the end of the pharmacotherapy period to the end of the NEAR combination treatment period will be assessed for all endpoints. Safety will also be evaluated.

Discussion: Achievement of adequate cognitive function is central to supporting social function, which is a key treatment goal for patients with schizophrenia. We think this study will fill in the gaps of the previous study and provide useful information regarding treatment decisions for patients with schizophrenia.

Clinical trial registration: Japan Registry of Clinical Trials ID, jRCTs031200338.

Keywords: Neuropsychological Educational Approach to Remediation (NEAR); antipsychotics; cognitive impairment; cognitive remediation; lurasidone; paliperidone; schizophrenia.

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This study was funded by Sumitomo Pharma Co., Ltd., which was involved in review of the research protocol developed by the protocol development committee, and writing of the report and decision to submit the report for publication; but will not be involved in the collection, management, analysis of data for this study and discussions of results interpretation.