1.Protocol on transcranial alternating current stimulation for the treatment of major depressive disorder: a randomized controlled trial
Wang HONG-XING ; Wang KUN ; Zhang WEN-RUI ; Zhao WEN-FENG ; Yang XIAO-TONG ; Wang LI ; Penn MAN ; Sun ZHI-CHAO ; Xue QING ; Jia YU ; Li NING ; Dong KAI ; Zhang QIAN ; Zhan SHU-QIN ; Min BAO-QUAN ; Fan CHUN-QIU ; Zhou AI-HONG ; Song HAI-QING ; Yin LU ; Si TIAN-MEI ; Huang JING ; Lu JIE ; Leng HAI-XIA ; Ding WEI-JUN ; Liu YUAN ; Yan TIAN-YI ; Wang YU-PING
Chinese Medical Journal 2020;133(1):61-67
Background:Transcranial 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.Methods:This 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.Discussion:The tACS applied in this trial may have treatment effects on MDD with minimal side effects.
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