Efficacy and Safety of Risperidone Microspheres for Injection (II) in Patients With Schizophrenia Spectrum Disorders: A Prospective, Single-Arm, Multicenter Real-World Study
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: Background: Long-acting injectable (LAI) antipsychotics improve adherence and promote long-term recovery in schizophrenia spectrum disorders (SSD). Risperidone Microspheres for Injection (II) (RMI-II), a novel LAI formulation, offers rapid symptom control with a 2-week dosing interval. However, real-world evidence regarding its efficacy and safety remains limited. Methods: A prospective, single-arm, multicenter study was conducted across 15 Chinese research centers. Eligible patients (n = 228) met DSM-5 criteria for SSD, had a Positive and Negative Syndrome Scale (PANSS) total score ≥70, and were followed for 12 weeks. Patients received RMI-II (25-50 mg/2 weeks) via intramuscular injection. Results: < 0.001). At week 2, 37.1% patients achieved clinical response (defined as ≥20% reduction in PANSS total score), and this proportion increased to 83.7% by week 12. By the end of the 12-week treatment, the clinical remission rate (defined as scores ≤3 on PANSS items P1, P2, P3, N1, N4, N6, G5, and G9) was 68.9%. The Clinical Global Impression-Severity Scale score improved from a baseline moderate-to-severe level 5.0 (5.0, 6.0) to a mild-to-moderate level 3.0 (2.0, 4.0). Adverse events occurred in 15.35% of patients, with hyperprolactinemia (1.3%) and extrapyramidal symptoms (1.3%) being most common. Conclusions: RMI-II appeared to be effective and well-tolerated in reducing acute psychotic symptoms. These findings suggest it may represent an additional therapeutic option for SSD. Clinical Trial Registration: No: ChiCTR2200066865, 20 December 2022, https://www.chictr.org.cn/showproj.html?proj=183302.
Source: ALPHA PSYCHIATRY
DOI: 10.31083/ap39454
Authors: Wei Li, Jinghui Tong, Xiaoxiao Gao, Hu Deng, Zezhi Li, Junhong Zhu, Jiahong Liu, Yanchi Zhang, Dengtang Liu, Xiaobin Zhang, Jianping Tang, Yuxiu Sui, Hezeng Yang, Yunshu Zhang, Chao Li, Xuhui Zhou, Baoping Xing, Yi Wang, Jiaqi Song, Rongzhen Zhang, Yang Shen, Yanying Song, Yanfang Zhou, Shujuan Pan, Wei Zheng, Yunlong Tan
Institutions: Peking University, Beijing HuiLongGuan Hospital, Guangzhou Medical University, Huazhong University of Science and Technology, Wenzhou Medical University, Sixth Hospital of Changchun City, Hebei Mental Health Center, Shanghai Jiao Tong University, Shanghai Mental Health Center, Soochow University, Hangzhou Seventh Peoples Hospital, Zhejiang University, Nanjing Brain Hospital, Shenzhen KangNing Hospital, Xian Mental Health Center, Second People Hospital of Hunan, Tongde Hospital of Zhejiang Province, Tianjin Anding Hospital, Tianjin Medical University
Language: English
Subfield: Psychiatry and Mental health
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W7159789638