Efficacy and Safety of tDCS and tACS in Treatment of Major Depressive Disorder: A Randomized, Double-Blind, Factorial Placebo-Controlled Study Design

Abstract

Background 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.