Protocol on transcranial alternating current stimulation for the treatment of major depressive disorder: a randomized controlled trial
- Author:
Wang HONG-XING
1
;
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
Author Information
- Keywords: Major depressive disorder; Transcranial alternating current stimulation; Treatment; Trial
- From: Chinese Medical Journal 2020;133(1):61-67
- CountryChina
- Language:Chinese
- Abstract: 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.
