Protocol on transcranial alternating current stimulation for the treatment of major depressive disorder: a randomized controlled trial / 中华医学杂志(英文版)
Chinese Medical Journal
; (24): 61-67, 2020.
Article
in En
| WPRIM
| ID: wpr-781607
Responsible library:
WPRO
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.@*TRIAL REGISTRATION@#Chinese Clinical Trial Registry, ChiCTR1800016479; http://www.chictr.org.cn/showproj.aspx?proj=22048.
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WPRIM
Type of study:
Clinical_trials
/
Guideline
Language:
En
Journal:
Chinese Medical Journal
Year:
2020
Type:
Article