Twice-daily 15 mA Transcranial Alternating Current Stimulation for Treatment-Resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS): Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score After 4 weeks of Treatment
研究概览
简要总结
This trial aims to investigate the effect of twice-daily 15 mA transcranial alternating current stimulation (tACS) through three conductive electrodes attached to the scalp in subjects with treatment-resistant depression (TRD). Two hundred adult subjects with TRD will be included in this randomized, double-blind, parallelized, multi-centre study. The primary outcome is the change of the Montgomery-Asberg Depression Rating Scale (MADRS) after four weeks of tACS.
详细描述
This is an 8-week, multicenter, double-blind, sham-controlled, randomized, parallel-group trial.
TRD is defined as failure of response to at least two antidepressant medication trials based on the Massachusetts General Hospital antidepressant treatment response questionnaire (MGH-ATRQ). Patients will be randomized if they remain moderately ill, assessed by Hamilton Depression Scale-item 17 (HAMD-17) score ≥ 20. The primary outcome is a change in the MADRS total score after four weeks of tACS.
"Remission" is defined as MADRS total score ≤10 at Week 4 and Week 8. "Response" is a ≥50% reduction in MADRS total score from baseline to Week 4 and Week 8.
All participants will receive 40 sessions with stimulation at 77.5 Hz and 15 mA (Active group) or sham stimulation (Sham group).
Each session will last 40 minutes from Monday to Friday at a fixed daytime interval for four continuous weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old;
- •able to provide written informed consent;
- •had a diagnosis of major depression disorder (MDD) (recurrent episodes) without psychotic features in compliance with the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revised (DSM-IV-TR) and confirmed by the Mini-International Neuropsychiatric Interview Chinese version 5.0;
- •failure to respond to at least two antidepressant medication trials based on the MGH-ATRQ;
- •ongoing antidepressant(s) at a fixed dose for at least four weeks before baseline assessment;
- •scored≥20 on the Hamilton Depression Scale-item 17 (HAMD-17) at baseline.
排除标准
- •Axis I psychiatric disorders, including schizophrenia, bipolar disorder, manic episodes, anxiety disorders (panic disorder, generalized anxiety disorder, and social anxiety disorder), post-traumatic stress disorder, obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, psychosis over the previous six months, and any disorders in Axis II (borderline personality disorder, antisocial personality disorder, schizotypal personality disorder, and narcissistic personality disorder);
- •a treatment history of electroconvulsive therapy (ECT), modified ECT, transcranial direct current stimulation, tACS, deep brain stimulation, and transcranial magnetic stimulation (TMS);
- •risk for suicide (defined as a score of ≥ 3 on the suicide item of HAMD-17);
- •known allergy to electrode materials;
- •inability to communicate with researchers fluently;
- •traumatic brain injury;
- •cerebrovascular or cardiovascular stents;
- •substance use disorder (abuse or dependence, as defined by DSM-IV-TR) in the previous six months;
- •for females, pregnant or breastfeeding, or females of childbearing potential refused to use reliable contraceptive methods during the study;
- •dementia (as defined by Short Blessed > 10 and/or clinical evidence of dementia);
- •participated in other clinical research within three months before enrollment in this study.
研究组 & 干预措施
Sham tACS
no active stimulation
干预措施: Sham tACS (Device)
active transcranial alternating current stimulation (tACS)
true stimulation.
干预措施: transcranial alternating current stimulation (tACS) (Device)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS): Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score After 4 weeks of Treatment
时间窗: week 0, 4
The MADRS has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).
次要结局
- EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 4 and Week 8 in EQ-5D-5L.(week 0, 4, 8)
- Montgomery-Asberg Depression Rating Scale (MADRS): remission (defined as MADRS total score ≤10) at Week 4 and Week 8; response is a ≥50% reduction in MADRS total score from baseline to Week 4 and Week 8(week 0, 4, 8)
- Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 4 and Week 8.(week 4, 8)
- Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to Week 4 and Week 8.(week 0, 4, 8)
- Clinical Global Impression-Severity (CGI-S): the change from baseline to Week 4 and Week 8 in Clinical Global Impression- Severity (CGI-S)(week 0, 4, 8)
研究者
wanghongxing
Professor, MD & PhD
Xuanwu Hospital, Beijing