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World J Psychiatry. Sep 19, 2026; 16(9): 121038
Published online Sep 19, 2026. doi: 10.5498/wjp.121038
Published online Sep 19, 2026. doi: 10.5498/wjp.121038
Real-world safety and effectiveness of lurasidone in Chinese children and adolescents with schizophrenia: Findings from a prospective cohort
Lei Zhang, Department of Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China
Yu-Mei Wei, Shanghai Clinical Research Center for Mental Health, School of Medicine, Shanghai Jiao Tong University, Shanghai 200030, China
Yi-Feng Shen, Shanghai Key Laboratory of Psychotic Disorders, Shanghai Clinical Research Center for Mental Health, School of Medicine, Shanghai Jiao Tong University, Shanghai 200030, China
Author contributions: Zhang L participated in the conception and design of the work, performed the data analysis, and wrote the first draft; Wei YM did the data management, contributed to the design of the study and critically revised the paper for important intellectual content; Shen YF participated in the conception and design of the work, interpreted the results, contributed to the design of the study and critically revised the paper for important intellectual content; all authors have read, reviewed, and approved the original drafts and final submitted version of the manuscript and agree to be held accountable for the work.
AI contribution statement: During the preparation of this work, the authors used AI tool exclusively for English language refinement, grammar correction, and improving the overall readability of the manuscript. The AI tool was not used for data analysis, interpretation of psychiatric clinical findings, or generation of original scientific ideas. After using this tool, the authors meticulously reviewed and edited the content to ensure clinical accuracy and take full responsibility for the scientific content, integrity, and final version of the publication.
Supported by Collaborative Innovation Center Project of Translational Medicine, Shanghai Jiaotong University School of Medicine, No. TM202116PT; Clinical Research Plan of SHDC, No. SHDC2022CRS032; and the Sumitomo Pharma (Suzhou) Co.,Ltd.
Institutional review board statement: The protocol of this study was approved by the ethics committee of the leading site, Shanghai Mental Health Center (approval No. 2019-72). All patients provided informed consent before enrollment.
Clinical trial registration statement: The clinical trial is registered in the Chinese Clinical Trial Registry (Registration ID: CTR20201022). Details are available at https://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml.
Informed consent statement: All patients provided informed consent before enrollment. For participants under 18 years, written informed consent was obtained from a parent or legal guardian.
Conflict-of-interest statement: Shen YF reports grants from Collaborative Innovation Center Project of Translational Medicine, Shanghai Jiaotong University School of Medicine, grants from Clinical Research Plan of SHDC, grants from Sumitomo Pharma (Suzhou) Co.,Ltd, during the conduct of the study.
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 analyzed during the current study are not publicly available due to data custodian restrictions and lack of ethics approval, but may be obtained from the corresponding author at shenyifeng@yahoo.com on reasonable request.
Corresponding author: Yi-Feng Shen, MD, Doctor, Shanghai Key Laboratory of Psychotic Disorders, Shanghai Clinical Research Center for Mental Health, School of Medicine, Shanghai Jiao Tong University, No. 600 Wanping Nan Road, Shanghai 200030, China.
Received: March 16, 2026
Revised: April 16, 2026
Accepted: July 3, 2026
Published online: September 19, 2026
Processing time: 163 Days and 23.2 Hours
Revised: April 16, 2026
Accepted: July 3, 2026
Published online: September 19, 2026
Processing time: 163 Days and 23.2 Hours
Core Tip
Core Tip: This is the first study to specifically evaluate lurasidone monotherapy in a substantial cohort of Chinese children and adolescents with schizophrenia, providing essential evidence on real-world dosing patterns, safety, and effectiveness. Pediatric patients were initiated on lurasidone at lower doses but underwent more rapid titration, ultimately reaching a slightly higher mean final and daily dose than adults. Lurasidone 40-80 mg/day was well tolerated with low rates of adverse events, suggesting potential clinical improvement, particularly in patients with more severe depressive symptoms. These findings suggest that lurasidone may be a promising treatment option for Chinese pediatric patients with schizophrenia.