Protocol on transcranial alternating current stimulation for the treatment of major depressive disorder:a randomized controlled trial  

作　　者：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 Yu-Ping Wang 

机构地区：[1]Departm ent of Neurology,Xuanwu Hospital,Capital Medical University,Beijing 100053,China [2]Beijing Key Laboratory of Neuromodulation,Beijing 100053,China [3]Center of Epilepsy,Beijing Institute for Brain Disorders,Capital Medical University,Beijing 100053,China [4]Department of Neurology,Beijing Puren Hospital,Beijing 100062,China [5]Medical Research&Biometrics Centre,National Centre for Cardiovascular Diseases,Beijing 102300,China [6]Peking University Sixth Hospital,Beijing 100083,China [7]Department of Radiology,Xuanwu Hospital,Capital Medical University,Beijing 100053,China [8]School of Life Science,Beijing Institute of Technology,Beijing 100081,China

出　　处：《Chinese Medical Journal》2020年第1期61-67,共7页中华医学杂志（英文版）

基　　金：This work is supported by the National Key R&D Program of China(No.2017YFC1310001);the National Natural Science Foundation of China(No.81771862);the Beijing Municipal Science and Technology Project(No.Z171100000117016);the Beijing Natural Science Foundation(No.KZ201710025017);the Beijing Hundred,Thousand,and Ten Thousand Talents Project(No.2017-CXYF-09).

摘　　要：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.Trial registration:Chinese Clinical Trial Registry,ChiCTR1800016479;http://www.chictr.org.cn/showproj.aspx?proj=22048.

关 键 词：Major depressive disorder Transcranial alternating current stimulation TREATMENT TRIAL 

分 类 号：R749[医药卫生—神经病学与精神病学]