Xu Chen, Zhao Yang, Yang Xueqin, Zheng Juan, Tang Qian
Department of Pharmacy, Guangyuan Central Hospital, Guangyuan, Sichuan, China.
Front Psychiatry. 2025 Jul 15;16:1599038. doi: 10.3389/fpsyt.2025.1599038. eCollection 2025.
To understand the current status of research and development (R&D) of psychotropic drugs.
Retrieved psychotropic drugs clinical trials (PDCTs) registered in China from 2019 to 2024 using the platform of , and systematically analyzed the data.
Included four perspectives: 1) for general information, we screened 1377 PDCTs, with phase bioequivalency (BE) accounting for the majority (78.5%), covering 411 pharmaceutical companies and 212 leading institutions, and the start-up time in 2024 was significantly shortened ( < 0.05); 2) for indications, 11 indications were involved, with the highest number of PDCTs for depression (30.9%); 3) for drugs, 222 drugs were involved, of which 52 were innovative drugs (33 with disclosed targets), and 13 were improved new drugs with six administration routes; 4) for trial design, four exploratory designs were retrieved, including population pharmacokinetics (9), pharmacogenomics (12), biomarker detection (3), and drug combination (3).
In recent years, clinical trials of psychotropic drugs in China have been developing. Innovative targets discovery, dosage forms/drug delivery systems optimization, and exploratory designs have the potential to break the current treatment dilemma. This study introduced the hotspots and potential development directions of psychotropic drugs R&D in China from the above aspects, providing new ideas for psychiatric treatment, drug development, and clinical trial methods.
了解精神药物研发的现状。
利用[具体平台名称]检索2019年至2024年在中国注册的精神药物临床试验（PDCTs），并对数据进行系统分析。
包括四个方面：1）一般信息方面，筛选出1377项PDCTs，其中生物等效性（BE）阶段占多数（78.5%），涉及411家制药公司和212家主要机构，2024年的启动时间显著缩短（<0.05）；2）适应症方面，涉及11种适应症，抑郁症的PDCTs数量最多（30.9%）；3）药物方面，涉及222种药物，其中52种为创新药物（33种有公开靶点），13种为改良新药，有六种给药途径；4）试验设计方面，检索到四种探索性设计，包括群体药代动力学（9项）、药物基因组学（12项）、生物标志物检测（3项）和药物联合（3项）。
近年来，中国精神药物临床试验不断发展。创新靶点发现、剂型/药物递送系统优化以及探索性设计有潜力打破当前的治疗困境。本研究从上述方面介绍了中国精神药物研发的热点和潜在发展方向，为精神疾病治疗、药物研发及临床试验方法提供了新思路。
