Observational Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Psychiatry. Nov 19, 2023; 13(11): 937-948
Published online Nov 19, 2023. doi: 10.5498/wjp.v13.i11.937
Safety and effectiveness of lurasidone in the treatment of Chinese schizophrenia patients: An interim analysis of post-marketing surveillance
Yu-Mei Wei, Xi-Jin Wang, Xiao-Dong Yang, Chuan-Sheng Wang, Li-Li Wang, Xiao-Ying Xu, Gui-Jun Zhao, Bin Li, Dao-Min Zhu, Qi Wu, Yi-Feng Shen
Yu-Mei Wei, Shanghai Clinical Research Center for Mental Health, School of Medicine, Shanghai Jiao Tong University, Shanghai 200030, China
Xi-Jin Wang, Department of Psychiatry, The First Psychiatric Hospital of Harbin, Harbin 150056, Heilongjiang Province, China
Xiao-Dong Yang, Department of Psychiatry, Shandong Provincial Mental Health Center, Jinan 250014, Shandong Province, China
Chuan-Sheng Wang, Department of Psychiatry, The Second Affiliated Hospital of Xinxiang Medical University, Xinxiang 453002, Henan Province, China
Li-Li Wang, Department of Psychiatry, Tianjin Mental Health Center, Tianjin Anding Hospital, Tianjin 300222, China
Xiao-Ying Xu, Department of Psychiatry, The Fifth People’s Hospital of Zigong, Zigong 643020, Sichuan Province, China
Gui-Jun Zhao, Department of Psychiatry, Guangyuan Mental Health Center, Guangyuan 628001, Guizhou Province, China
Bin Li, Department of Psychology, Fujian Energy General Hospital, Fuzhou 350001, Fujian Province, China
Dao-Min Zhu, Department of Sleep Disorders, Affiliated Psychological Hospital of Anhui Medical University, Hefei Fourth People’s Hospital, Anhui Mental Health Center, Hefei 230022, Anhui Province, China
Qi Wu, Sumitomo Pharma (China), Co., Ltd., Shanghai 200025, China
Yi-Feng Shen, Shanghai Key Laboratory of Psychotic Disorders, Shanghai Clinical Research Center for Mental Health, Shanghai Jiao Tong University, Shanghai 200030, China
Author contributions: Wang XJ, Yang XD, Wang CS, Wang LL, Xu XY, Zhao GJ, Li B, Zhu DM and Shen YF contributed to data acquisition, data analysis and interpretation; Wei YM and Wu Q contributed to the study concept, design and data analysis; All authors read and approved the final manuscript.
Supported by Collaborative Innovation Center Project of Translational Medicine, Shanghai Jiaotong University School of Medicine, No. TM202116PT (2021-2023); Clinical Research Plan of SHDC, No. SHDC2022CRS032; and the Sumitomo Pharmaceuticals (Suzhou) Co., Ltd.
Institutional review board statement: The study protocol was approved by the ethics committees of Shanghai Mental Health Center (the leading site) and other sites.
Informed consent statement: The patients were required to provide informed consent before participating.
Conflict-of-interest statement: The authors declare no conflicts of interest.
Data sharing statement: No additional data are available.
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: Yi-Feng Shen, MD, PhD, Professor, Shanghai Key Laboratory of Psychotic Disorders, Shanghai Clinical Research Center for Mental Health, Shanghai Jiao Tong University, No. 600 Wanping Nan Road, Shanghai 200030, China, Shanghai 200030, China. shenyifeng@sina.com
Received: August 23, 2023
Peer-review started: August 23, 2023
First decision: September 28, 2023
Revised: October 11, 2023
Accepted: October 27, 2023
Article in press: October 27, 2023
Published online: November 19, 2023

Schizophrenia is a psychiatric disorder characterized by chronic or recurrent symptoms. Lurasidone was licensed in China in 2019 for the treatment of adult schizophrenia in adults with a maximum dose of 80 mg/d. However, post-market surveillance (PMS) with an adequate sample size is required for further validation of the drug’s safety profile and effectiveness.


To conduct PMS in real-world clinical settings and evaluate the safety and effectiveness of lurasidone in the Chinese population.


A prospective, multicenter, open-label, 12-wk surveillance was conducted in mainland China. All patients with schizophrenia from 10 sites who had begun medication with lurasidone between September 2019 and August 2022 were eligible for enrollment. Safety assessments included adverse events (AEs), adverse drug reactions (ADRs), extrapyramidal symptoms (EPS), akathisia, use of EPS drugs, weight gain, and laboratory values as metabolic parameters and the QTc interval. The effectiveness was assessed using the brief psychiatric rating scale (BPRS) from baseline to the end of treatment.


A total of 965 patients were enrolled in the full analysis set and 894 in the safety set in this interim analysis. The average daily dose was 61.7 ± 19.08 mg (mean ± SD) during the treatment. AEs and ADRs were experienced by 101 patients (11.3%) and 78 patients (8.7%), respectively, which were mostly mild. EPS occurred in 25 individuals with a 2.8% incidence, including akathisia in 20 individuals (2.2%). Moreover, 59 patients received drugs for treating EPS during the treatment, with an incidence of 6.6% which dropped to 5.4% at the end of the treatment. The average weight change was 0.20 ± 2.36 kg (P = 0.01687) with 0.8% of patients showing a weight gain of ≥ 7% at week 12 compared with that at the baseline. The mean values of metabolic parameters and the QTc interval at baseline and week 12 were within normal ranges. The mean changes in total BPRS scores were -8.9 ± 9.76 (n = 959), -13.5 ± 12.29 (n = 959), and -16.8 ± 13.97 (n = 959) after 2/4, 6/8, and 12 wk, respectively (P < 0.001 for each visit compared with the baseline) using the last-observation-carried-forward method.


The interim analysis of the PMS of adult patients with schizophrenia demonstrate the safety and effectiveness of lurasidone in the Chinese population. No new safety or efficacy concerns were identified.

Keywords: Lurasidone, Safety, Effectiveness, Surveillance, Schizophrenia, Chinese

Core Tip: We conducted the first post-marketing surveillance of the actual use of lurasidone in the treatment of patients with schizophrenia in real-world clinical practice since the drug was licensed in mainland China in 2019, and evaluated the safety profile and effectiveness of lurasidone in Chinese population. Here, we report an interim analysis based on 965 patients who received the medication between 2019 and 2022. This study hold significance as it contributes additional safety and effectiveness data on lurasidone beyond what was gathered in pre-marketing trials. Furthermore, it provides valuable reference information for clinical decision-making of schizophrenia treatment.