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:T...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.展开更多
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)+2 种基金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).
文摘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.
