Prospective Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Psychiatry. Nov 19, 2024; 14(11): 1735-1745
Published online Nov 19, 2024. doi: 10.5498/wjp.v14.i11.1735
Who can benefit more from its twelve-week treatment: A prospective cohort study of blonanserin for patients with schizophrenia
Bao-Yan Xu, Kun Jin, Hai-Shan Wu, Xue-Jun Liu, Xi-Jin Wang, Hong Sang, Ke-Qing Li, Mei-Juan Sun, Hua-Qing Meng, Huai-Li Deng, Zhi-Yuan Xun, Xiao-Dong Yang, Lin Zhang, Guan-Jun Li, Rui-Ling Zhang, Duan-Fang Cai, Jia-Hong Liu, Gui-Jun Zhao, Long-Fa Liu, Gang Wang, Chang-Lie Zhao, Bin Guo, Sheng-Chun Jin, Ling-Yun Huang, Fu-De Yang, Jian-Min Zheng, Gui-Lai Zhan, Mao-Sheng Fang, Xiang-Jun Meng, Guang-Ya Zhang, Hai-Min Li, Xiang-Lai Liu, Ju-Hong Li, Bin Wu, Hai-Yun Li, Jin-Dong Chen
Bao-Yan Xu, Kun Jin, Hai-Shan Wu, 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
Bao-Yan Xu, Ke-Qing Li, Department of Psychiatry, Hebei Provincial Mental Health Center, Hebei Key Laboratory of Major Mental and Behavioral Disorders, The Sixth Clinical Medical College of Hebei University, Baoding 071000, Hebei Province, China
Xue-Jun Liu, Department of Psychiatry, Brain Hospital of Hunan Province, Changsha 410000, Hunan Province, China
Xi-Jin Wang, Department of Psychiatry, The First Psychiatric Hospital of Harbin, Harbin 150000, Heilongjiang Province, China
Hong Sang, Mental Health Center, Changchun Sixth Hospital, Changchun 130000, Jilin Province, China
Mei-Juan Sun, Department of Pharmacy, Daqing Third Hospital, Daqing 163000, Heilongjiang Province, China
Hua-Qing Meng, Department of Physical and Psychological Rehabilitation, Guangda Rehabilitation Hospital, Chongqing 400000, China
Huai-Li Deng, Department of Psychology, Shanxi Provincial Mental Health Center, Taiyuan 030000, Shanxi Province, China
Zhi-Yuan Xun, Department of Psychiatry, Tianjin Anding Hospital, Tianjin 300000, China
Xiao-Dong Yang, Department of Psychiatry, Shandong Mental Health Center, Jinan 250000, Shandong Province, China
Lin Zhang, Department of Psychiatry, Fuzhou Shenkang Hospital, Fuzhou 350000, Fujian Province, China
Guan-Jun Li, Department of Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200000, China
Rui-Ling Zhang, Department of Psychiatry, The Second Affiliated Hospital of Xinxiang Medical University, Xinxiang 453000, Henan Province, China
Duan-Fang Cai, Department of Psychiatry, The Fifth People’s Hospital of Zigong, Zigong 643000, Sichuan Province, China
Jia-Hong Liu, Department of Psychiatry, The Affiliated Kangning Hospital of Wenzhou Medical University, Wenzhou 325000, Zhejiang Province, China
Gui-Jun Zhao, Department of Psychiatry, Guangyuan Mental Health Center, Guangyuan 628000, Sichuan Province, China
Long-Fa Liu, Department of Psychiatry, Jilin Sixth People’s Hospital, Jilin 132000, Jilin Province, China
Gang Wang, The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing 100000, China
Gang Wang, Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing 100000, China
Chang-Lie Zhao, Department of Psychiatry, Yanbian Brain Hospital, Yanbian 133000, Jilin Province, China
Bin Guo, Department of Psychiatry, Mudanjiang Psychiatric Hospital, Mudanjiang 157000, Heilongjiang Province, China
Sheng-Chun Jin, Department of Psychiatry, Anhui Mental Health Center, Hefei 230000, Anhui Province, China
Ling-Yun Huang, Mental Health Center, Yueqing Third People’s Hospital, Yueqing 325600, Zhejiang Province, China
Fu-De Yang, Psychiatry Research Center, Beijing Huilongguan Hospital, Beijing 100000, China
Jian-Min Zheng, Department of Mental Health, Fuzhou Taijiang Xinshengkang Psychiatric Clinic, Fuzhou 350000, Fujian Province, China
Gui-Lai Zhan, Department of Psychiatry, Xuhui Mental Health Center, Shanghai 200000, China
Mao-Sheng Fang, Department of Psychiatry, Affiliated Wuhan Mental Health Center, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430000, Hubei Province, China
Xiang-Jun Meng, Dean’s Office, Qingdao Mental Health Center, Qingdao 266000, Shandong Province, China
Guang-Ya Zhang, Department of Psychiatry, Suzhou Guangji Hospital, Affiliated Guangji Hospital of Soochow University, Suzhou 215000, Jiangsu Province, China
Hai-Min Li, Department of Psychiatry, Chengdu Qingyang Aaron Clinic, Chengdu 610000, Sichuan Province, China
Xiang-Lai Liu, Institute of Mental Health, Hainan Provincial Anning Hospital, Haikou 570000, Hainan Province, China
Ju-Hong Li, Department of Psychiatry, The Fourth People’s Hospital of Chengdu, Chengdu 610000, Sichuan Province, China
Bin Wu, Department of Psychiatry, Xi’an Mental Health Center, Xi’an 710000, Shaanxi Province, China
Hai-Yun Li, Medical Affairs, Sumitomo Pharma (Suzhou) Co., Ltd., Shanghai 200000, China
Co-first authors: Bao-Yan Xu and Kun Jin.
Author contributions: Xu BY and Jin K contributed equally to this work. Xu BY, Jin K, and Wu HS wrote the manuscript; Wu HS, Chen JD, and Li HY contributed to the study concept, design and analysis; Xu BY, Jin K, Wu HS, Liu XJ, Wang XJ, Sang H, Li KQ, Sun MJ, Meng HQ, Deng HL, Xun ZY, Yang XD, Zhang L, Li GJ, Zhang RL, Cai DF, Liu JH, Zhao GJ, Liu LF, Wang G, Zhao CL, Guo B, Jin SC, Huang LY, Yang FD, Zheng JM, Zhan GL, Fang MS, Meng XJ, Zhang GY, Li HM, Liu XL, Li JH, and Wu B acquired, analyzed, and interpreted data; and all the authors approved for submitting the manuscript.
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 number: 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: Hai-Yun Li is an employee of Sumitomo Pharma (Suzhou) Co., Ltd. The other authors report no relevant conflicts of interest for this article.
Data sharing statement: There are no additional data available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
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: Jin-Dong Chen, PhD, Professor, Department of Psychiatry, National Clinical Research Center for Mental Disorders, National Center for Mental Disorders, The Second Xiangya Hospital of Central South University, No. 139 Middle Renmin Road, Changsha 410011, Hunan Province, China. chenjindong@csu.edu.cn
Received: August 30, 2024
Revised: October 14, 2024
Accepted: October 29, 2024
Published online: November 19, 2024
Processing time: 69 Days and 1.4 Hours
Abstract
BACKGROUND

Blonanserin (BNS) is a well-tolerated and effective drug for treating schizophrenia.

AIM

To investigate which types of patients would obtain the most benefit from BNS treatment.

METHODS

A total of 3306 participants were evaluated in a 12-week, prospective, multicenter, open-label post-marketing surveillance study of BNS. Brief psychiatric rating scale (BPRS) scores were calculated to evaluate the effectiveness of BNS, and its safety was assessed with the incidence of adverse drug reactions. Linear regression was used to screen the influencing factors for the reduction of BPRS total score, and logistic regression was used to identify patients with a better response to BNS.

RESULTS

The baseline BPRS total score (48.8 ± 15.03) decreased to 27.7 ± 10.08 at 12 weeks (P < 0.001). Extrapyramidal symptoms (14.6%) were found to be the most frequent adverse drug reactions. The acute phase, baseline BPRS total score, current episode duration, number of previous episodes, dose of concomitant antipsychotics, and number of types of sedative-hypnotic agents were found to be independent factors affecting the reduction of BPRS total score after treatment initiation. Specifically, patients in the acute phase with baseline BPRS total score ≥ 45, current episode duration < 3 months, and ≤ 3 previous episodes derived greater benefit from 12-week treatment with BNS.

CONCLUSION

Patients in the acute phase with more severe symptoms, shorter current episode duration, fewer previous episodes, and a lower psychotropic drug load derived the greatest benefit from treatment with BNS.

Keywords: Schizophrenia; Blonanserin; Effectiveness; Psychosocial functioning; Prospective cohort study

Core Tip: This analysis included a large sample of 3306 patients with schizophrenia from the first post-marketing surveillance of blonanserin (BNS) in China. Our aim was to explore factors influencing treatment outcomes to assist in the early identification of patients with schizophrenia who are suitable for specific treatments like BNS. We found that patients in the acute phase with more severe symptoms, shorter current episode duration, and fewer previous episodes who were treated with a lower dose of concomitant antipsychotics and fewer types of sedative-hypnotic agents benefited the most from BNS treatment. These results provide valuable evidence for a more reasonable application of BNS in China.