Safety and efficacy of different initial doses of lurasidone in the schizophrenia treatment: A multi-center, randomized, open-label study

doi:10.5498/wjp.v15.i10.110968

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World Journal of Psychiatry

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2220-3206

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Clinical Trials Study

World J Psychiatry. Oct 19, 2025; 15(10): 110968
Published online Oct 19, 2025. doi: 10.5498/wjp.v15.i10.110968

Safety and efficacy of different initial doses of lurasidone in the schizophrenia treatment: A multi-center, randomized, open-label study

Qi Liu, Min-Cai Qian, Zhi-Fen Liu, Fang Dong, Deng-Tang Liu, Ming-Li Li, Yu-Ping Ning, Xiao-Ping Wang, Tie-Bang Liu, Qi Wu, Tao Li, Xin Yu

Qi Liu, Department of Psychological Counseling, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing 100191, China

Min-Cai Qian, Department of Neurosis and Psychosomatic Diseases, The Third People’s Hospital Affiliated to Huzhou University, Huzhou 313000, Zhejiang Province, China

Zhi-Fen Liu, Department of Psychiatry, The First Hospital of Shanxi Medical University, Taiyuan 030001, Shanxi Province, China

Fang Dong, Beijing Key Laboratory of Mental Disorders, The National Clinical Research Center for Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China

Deng-Tang Liu, Department of Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China

Ming-Li Li, Mental Health Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China

Yu-Ping Ning, Department of Neurology, The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou 510370, Guangdong Province, China

Xiao-Ping Wang, Department of Psychiatry, National Clinical Research Center for Mental Disorders, National Center for Mental Disorders, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, China

Tie-Bang Liu, Department of Psychiatry, Shenzhen Kangning Hospital, and Shenzhen Mental Health Center, Shenzhen 518118, Guangdong Province, China

Qi Wu, Sumitomo Pharma (China), Co., Ltd., Shanghai 200025, China

Tao Li, Department of Neurobiology, The Affiliated Mental Health Center and Hangzhou Seventh People’s Hospital, Zhejiang University School of Medicine, Hangzhou 310063, Zhejiang Province, China

Xin Yu, Department of Psychiatry, Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing 100191, China

Co-first authors: Qi Liu and Min-Cai Qian.

Co-corresponding authors: Tao Li and Xin Yu.

Author contributions: Liu Q and Qian MC contributed equally to clinical data analysis and manuscript drafting, they contributed equally to this manuscript and are co-first authors; Liu ZF, Dong F, Liu DT, Li ML, Ning YP, Wang XP, and Liu TB contributed to clinical data collection, statistical analysis, methodology, and outcome validation; Wu Q contributed to clinical study design; Li T and Yu X equally supervised the study as corresponding authors and contributed to study concept, with Yu X handling submission correspondence. All the authors contributed to this manuscript.

Institutional review board statement: We declare that this study was approved by the Ethical Committee of the leading clinical site at of the Peking University Sixth Hospital. The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008.

Clinical trial registration statement: This study is registered at https://clinicaltrials.gov/. The registration identification number is NCT05011669.

Informed consent statement: All patients signed the informed consent form.

Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.

CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.

Data sharing statement: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/

Corresponding author: Xin Yu, PhD, Department of Psychiatry, Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), No. 51 Huayuanbei Road, Beijing 100191, China. yuxin@bjmu.edu.cn

Received: June 20, 2025
Revised: July 10, 2025
Accepted: August 15, 2025
Published online: October 19, 2025
Processing time: 99 Days and 4.6 Hours

Abstract

BACKGROUND

Schizophrenia, a complex group of mental disorders, is primarily managed with antipsychotic medications. The safety and efficacy of different initial doses of lurasidone for acute schizophrenia remain uncertain, particularly concerning discontinuation rates due to adverse events (AEs).

AIM

To compare the safety of two initial doses of lurasidone for the treatment of acute schizophrenia in Chinese patients.

METHODS

This 6-week, randomized, open-label, multicenter trial allocated participants to receive either 40 mg/day or 80 mg/day lurasidone initially, with dose adjustment allowed after a one-week fixed-dose period. Safety assessments included the primary endpoint of discontinuation due to AEs, as well as evaluations of AEs, weight changes, and laboratory parameters. Efficacy assessments included responder rates and changes in scores on the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Severity scale, and Calgary Depression Scale for Schizophrenia.

RESULTS

Among 197 participants, no significant difference was found in discontinuation rate due to AEs between groups (3.03% vs 5.10%, P = 0.707). Treatment-emergent AEs were reported in 64.6% and 71.4% of participants in the 40 mg/day and 80 mg/day initiation groups, respectively. Response rates at weeks 1 and 2 showed no statistically significant differences. Both groups demonstrated significant improvements in PANSS total, Clinical Global Impression-Severity, and Calgary Depression Scale for Schizophrenia scores from baseline (all P < 0.01). Notably, the 80 mg/day initiation group showed greater improvement in the PANSS positive subscale score at visits 1 and 2 compared to the 40 mg/day initiation group (P < 0.05).

CONCLUSION

Initial doses of 40 mg/day and 80 mg/day lurasidone are safe and effective for acute schizophrenia, with no significant increase in AEs-related discontinuation rate at the higher dose.

Keywords: Schizophrenia; Discontinuation rate; Efficacy; Safety; Lurasidone

Core Tip: This randomized, multicenter study innovatively compares initial lurasidone doses (40 mg/day vs 80 mg/day) in Chinese patients with acute schizophrenia, addressing a critical gap in dose optimization. Key findings reveal no significant difference in discontinuation rates due to adverse events (3.03% vs 5.10%, P = 0.707), affirming the tolerability of higher initial dosing. Notably, the 80 mg/day group showed superior early improvement in Positive and Negative Syndrome Scale positive subscale scores (P < 0.05) without exacerbating metabolic risks. These results challenge conventional dosing paradigms, suggesting 80 mg/day as a viable initial option for rapid symptom control, while maintaining safety.