Prospective Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Psychiatry. May 19, 2025; 15(5): 103701
Published online May 19, 2025. doi: 10.5498/wjp.v15.i5.103701
Effectiveness and safety of blonanserin monotherapy for first-episode schizophrenia with and without prominent negative symptoms: A prospective study
Li-He Chen, Qian Guo, Yao Hu, Xiao-Hua Liu, Hao Hu, Hai-Ying Chen, Cai-Ping Liu, Hua-Fang Li, Jin-Dong Chen, Guan-Jun Li
Li-He Chen, Qian Guo, Yao Hu, Xiao-Hua Liu, Hao Hu, Hai-Ying Chen, Cai-Ping Liu, Hua-Fang Li, Guan-Jun Li, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China
Jin-Dong Chen, 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
Co-first authors: Li-He Chen and Qian Guo.
Co-corresponding authors: Jin-Dong Chen and Guan-Jun Li.
Author contributions: Chen LH, Guo Q, and Li GJ contributed to the methodology of this manuscript; Chen LH and Hu H participated in the software development; Chen LH, Guo Q, Hu Y, and Chen HY took part in the data curation; Chen LH, Guo Q, Hu H, and Li GJ contributed to the writing - review & editing; Chen LH was involved in the formal analysis, writing - original draft, and visualization of the manuscript; Guo Q and Li GJ participated in the conceptualization of the study; Guo Q, Hu Y, Liu XH, Chen HY, Liu CP, Li HF, Chen JD, and Li GJ contributed to the project administration; Guo Q, Hu Y, and Liu CP took part in the validation of this manuscript; Hu H, Li HF, and Chen JD contributed to the investigation of this manuscript; Li HF and Li GJ were involved in the funding acquisition; Li HF, Chen JD, and Li GJ contributed to the resources and supervision. Chen LH and Guo Q contributed equally as co-first authors and Chen JD and Li GJ contributed equally as co-corresponding authors.
Institutional review board statement: This study was approved by the ethics committees of the leading site, The Second Xiangya Hospital of Central South University (Approval No. 2018-093), and the other sites.
Clinical trial registration statement: The study was registered on the official website of clinical trials (http://www.chictr.org.cn, ID: CTR2100048734).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors have no conflicts of interest to declare.
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: There are no additional data 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: Guan-Jun Li, PhD, Chief Physician, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, No. 600 Wanping Nan Road, Shanghai 200030, China. liguanjun66@126.com
Received: November 29, 2024
Revised: January 24, 2025
Accepted: March 17, 2025
Published online: May 19, 2025
Processing time: 153 Days and 0.2 Hours
Abstract
BACKGROUND

Blonanserin, a novel antipsychotic, has demonstrated efficacy in treating both positive and negative symptoms. However, limited research exists on its dose-dependent effectiveness and safety in patients with and without prominent negative symptoms (PNS).

AIM

To evaluate the effectiveness and safety of blonanserin monotherapy for first-episode schizophrenia in real-world clinical settings and to explore the efficacy and safety of different doses of blonanserin for patients with PNS and without PNS.

METHODS

A 12-week, multicenter, prospective post-marketing surveillance was conducted. In this study, we included patients with first-episode schizophrenia who received blonanserin monotherapy. Patients were divided into those with PNS and without PNS, based on the Brief Psychiatric Rating Scale (BPRS) negative symptoms subscale scores. Additionally, patients were labeled as high-dose and low-dose groups according to the maximum daily dose they received. Effectiveness was assessed using the BPRS, and safety was evaluated through the incidence of adverse drug reactions (ADRs).

RESULTS

A total of 653 patients were included in the analysis, with 613 completing the study. The BPRS total score decreased significantly from 47.94 ± 16.31 at baseline to 26.88 ± 9.47 at 12 weeks (P < 0.001). A significant interaction of PNS × dose × time was observed for BPRS total scores (F = 3.47, P = 0.040) and negative symptom subscale scores (F = 6.76, P = 0.002). In the PNS group, the high-dose group showed greater reductions in BPRS total scores (P = 0.001) and negative symptom subscale scores (P = 0.003) than the low-dose group in week 12. In the without PNS group, no significant difference was observed between the high-dose and low-dose groups at any visit. Most adverse reactions were mild or moderate, with extrapyramidal symptoms (9.3%) being most common; 1.5% of patients gained ≥ 7% body weight at 12 weeks.

CONCLUSION

Blonanserin effectively alleviated the clinical symptoms of first-episode schizophrenia with an acceptable safety profile. High-dose blonanserin is particularly beneficial for patients with PNS in the acute phase of first-episode schizophrenia. However, due to the limitation of ADR reporting the real world, the ADR incidence observed in this study may be underestimated.

Keywords: Schizophrenia; Blonanserin; Negative symptoms; Effectiveness; Safety; Dose

Core Tip: Blonanserin effectively improved the overall and negative symptoms of first-episode schizophrenia with an acceptable safety profile. High-dose blonanserin showed greater efficacy than low-dose for patients with prominent negative symptoms (PNS) without an increase in adverse drug reactions. Conversely, low-dose blonanserin provided comparable clinical improvement and safety compared to high-dose for patients without PNS.