Neuropsychiatric Disease and Treatment (May 2021)
Efficacy and Safety of tDCS and tACS in Treatment of Major Depressive Disorder: A Randomized, Double-Blind, Factorial Placebo-Controlled Study Design
Abstract
Yuxin Huang,1 Linjie Shen,1 Jia Huang,1 Xianrong Xu,2 Yong Wang,1 Hua Jin1 1Department of Outpatient, Shanghai Mental Health Center, Shanghai, People’s Republic of China; 2School of Public Health, Hangzhou Normal University, Hnagzhou, Zhejiang Province, People’s Republic of ChinaCorrespondence: Yong WangDepartment of Outpatient, Shanghai Mental Health Center, No. 600 Wanping South Road, Xuhui District, Shanghai, People’s Republic of ChinaTel +86-18017311332Email [email protected]: Transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS) are regarded as promising antidepressant treatments.Objective: To compare the efficacy and safety of tDCS, tACS, escitalopram, and placebo/sham stimulation controls.Design: Randomized, parallel, double-blind, placebo-controlled study.Methods: Sample sizes were calculated based on data from previous similar studies. Eligible non-treatment-resistant-depressive outpatient subjects with moderate-to-severe depression (HRDS ≥ 17) are randomized to receive (1) tDCS + placebo; (2) tACS + placebo; (3) escitalopram + placebo; or (4) sham stimulation + placebo. The intensity of electricity is 2 mA, lasting for 30 minutes over two consecutive working days (10 sessions in total). The medication lasts for 6 weeks. The primary outcome measure was the response rates within 6 weeks (week 6 is also the endpoint of the study), and secondary outcome measures included changes in other clinical measurements. Safety and acceptability are measured by adverse event rates and dropout rates. Exploring outcome consist of the performance of cognitive battery as well as neurophysiology results.Conclusion: To the best of our knowledge, the present study is the first double-blind controlled study comparing tDCS, tACS, and clinically used antidepressants, which will provide further evidence for their efficacy and safety in possible clinical applications.Keywords: transcranial direct current stimulation, tDCS, transcranial alternating current stimulation, tACS, electrical stimulation, major depressive disorder, MDD
