Current Status of Antidepressant Drug Research and Development in China: A Feature Analysis Based on Drug Clinical Trial Registration and Information Disclosure Platform

Abstract

Objective: To systematically review the clinical trial data of registered antidepressant drugs in China, conducted an in-depth analysis of their current status and development trends, and provided reference for the research and development of antidepressants. Methods: Clinical trials of registered antidepressant drugs registered from April 16,2013, to December 31,2025, were searched. The development status of antidepressant drug clinical trials in China was analyzed from various aspects, including drug types, indications, trial classification, phase, and design types. Results: A total of 675 trials were included, comprising 667 domestic multicenter trials and 8 international multicenter trials. Among them, chemical drugs accounted for 96.0%, while biological products were absent. There were 500 bioequivalence studies (74.1%), with Phase II and III trials employing parallel group, randomized, and double-blind designs. 501 (74.2%) clinical trials provided trial injury insurance for participants, and research resources were concentrated in leading psychiatric specialty hospitals. Conclusion: Although the overall development of antidepressant drug clinical trials in China has shown a steady trend, the number of international multicenter trials remains significantly low, while bioequivalence studies and early exploratory trials are more prevalent. Future efforts should focus on strengthening international cooperation and exchange, as well as innovative drug development, to accelerate the fulfillment of clinical needs for patients with depression in China.