• Hong-Xing Wang, Kun Wang, Wen-Rui Zhang, Wen-Feng Zhao, Xiao-Tong Yang, Li Wang, Mao Peng, Zhi-Chao Sun, Qing Xue, Yu Jia, Ning Li, Kai Dong, Qian Zhang, Shu-Qin Zhan, Bao-Quan Min, Chun-Qiu Fan, Ai-Hong Zhou, Hai-Qing Song, Lu Yin, Tian-Mei Si, Jing Huang, Jie Lu, Hai-Xia Leng, Wei-Jun Ding, Yuan Liu, Tian-Yi Yan, and Yu-Ping Wang.
• Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
• Chin. Med. J. 2020 Jan 5; 133 (1): 616761-67.

BackgroundTranscranial alternating current stimulation (tACS) offers a new approach for adult patients with major depressive disorder (MDD). The study is to evaluate the efficacy and safety of tACS treating MDD.MethodsThis is an 8-week, double-blind, randomized, placebo-controlled study. Ninety-two drug-naive patients with MDD aged 18 to 65 years will receive 20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS targeting the forehead and both mastoid areas on weekdays for 4 consecutive weeks (week 4), following a 4-week observation period (week 8). The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8. Secondary outcomes are the rates of response at weeks 4 and 8 and rate of remission at week 4 based on HDRS-17, the proportion of participants having improvement in the clinical global impression-improvement, the change in HDRS-17 score (range, 0-52, with higher scores indicating more depression) over the study, and variations of brain imaging and neurocognition from baseline to week 4. Safety will be assessed by vital signs at weeks 4 and 8, and adverse events will be collected during the entire study.DiscussionThe tACS applied in this trial may have treatment effects on MDD with minimal side effects.Trial RegistrationChinese Clinical Trial Registry, ChiCTR1800016479; http://www.chictr.org.cn/showproj.aspx?proj=22048.

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