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
This cross-sectional study recruited consecutively 347 patients (178 males,169 females) aged 19 to 30 years with a diagnosis of MDD according to Diagnostic and Statistical Manual of Mental Disorders,Fifth Edition (DSM...This cross-sectional study recruited consecutively 347 patients (178 males,169 females) aged 19 to 30 years with a diagnosis of MDD according to Diagnostic and Statistical Manual of Mental Disorders,Fifth Edition (DSM-V) criteria who underwent in-person interviews,the mini international neuropsychiatric interview,and physical examinations by experienced psychiatrists at Division of Neuropsychiatry,Department of Neurology,Xuanwu Hospital of Capital Medical University (Beijing,China) between August 20,2015,and December 28,2018.All patients were excluded with anemia,thyroid dysfunction,mental retardation,neurologic conditions,bipolar disorders,schizophrenia,and other mental disorders.Depressive symptoms were assessed with the Hamilton rating scale for depression (HAMD-17) by three experienced psychological testing technicians who were blinded to all subjects' birth delivery types at the Neuropsychological Center of Department of Neurology of Xuanwu Hospital.The study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of Xuanwu Hospital.As a retrospective study and data analysis were performed anonymously,this study was exempt from the informed consent from patients.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.
基金grants from the Beijing Muni cipal Science and Technology Project (No. Z171100000117016)National Natural Science Foundation of China (No. 81771862)+1 种基金the Beijing Natural Science Foundation (No. KZ201710025017), the Beijing Municipal Hospital Research and Development Plan (No. PX2017069)the Beijing Hundred, Thousand, and Ten Thousand Talents Project (No. 2017-CXYF-09).
文摘This cross-sectional study recruited consecutively 347 patients (178 males,169 females) aged 19 to 30 years with a diagnosis of MDD according to Diagnostic and Statistical Manual of Mental Disorders,Fifth Edition (DSM-V) criteria who underwent in-person interviews,the mini international neuropsychiatric interview,and physical examinations by experienced psychiatrists at Division of Neuropsychiatry,Department of Neurology,Xuanwu Hospital of Capital Medical University (Beijing,China) between August 20,2015,and December 28,2018.All patients were excluded with anemia,thyroid dysfunction,mental retardation,neurologic conditions,bipolar disorders,schizophrenia,and other mental disorders.Depressive symptoms were assessed with the Hamilton rating scale for depression (HAMD-17) by three experienced psychological testing technicians who were blinded to all subjects' birth delivery types at the Neuropsychological Center of Department of Neurology of Xuanwu Hospital.The study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of Xuanwu Hospital.As a retrospective study and data analysis were performed anonymously,this study was exempt from the informed consent from patients.
