NCT07042217招募中不适用
A Randomized, Double-blind, Parallel-arm, Sham-controlled Trial of ElectraRx Mindfulness Transcranial Direct Current Treatment System (Elect-MDS) for Adults With Major Depressive Disorder
Soterix Medical2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Hamilton Depression Rating Scale (HDRS)
研究概览
简要总结
This study will test the efficacy of transcranial direct current stimulation (tDCS) combined with mindfulness, remotely-delivered using a telemedicine protocol in 25 adults with unipolar depression.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable patients that meet criteria for diagnosis of MDD according to DSM-V-TR and confirmed with the Mini International Neuropsychiatric interview
- •Currently experiencing a major depressive episode of at least 4 week's duration as part of a unipolar depression
- •QIDS-SR score >11 on all three days of screening week (Days 1,3, 7)
- •Scored at least 17 (inclusive) on the HDRS-17 at trial entry
- •Any antidepressant medication is stable ≥ 30 days prior to HDRS-17 screening
- •Female patients are allowed if not pregnant and using a medically acceptable method of contraception, if of childbearing potential.
排除标准
- •Failure to respond to at least 2 antidepressant medications
- •Drug or alcohol abuse or dependence in the preceding 3 months
- •Concurrent benzodiazepine medication
- •High suicide risk assessed during clinician screening at baseline interview.
- •Failure to respond to ECT treatment or rTMS treatment in this or any previous episode.
- •Current DSM-V-TR psychotic disorder
- •History of clinically defined neurological disorder or insult that may impact participation in this study as determined by study physician
- •Metal in the cranium or skull defects
- •Implanted pump, neurostimulator, cardiac pacemaker or defibrillator
- •Skin lesions on scalp at the proposed electrode sites
- •Pregnancy
研究组 & 干预措施
Active tDCS and Mindfulness
Experimental
Application of electrical stimulation to the brain non-invasively combined with mindfulness
干预措施: transcranial direct current stimulation (tDCS) and mindfulness instruction (Device)
Sham tDCS and Mindfulness
Sham Comparator
Sham electrical stimulation and mindfulness
干预措施: Sham tDCS and Mindfulness (Device)
结局指标
主要结局
Hamilton Depression Rating Scale (HDRS)
时间窗: Week 4 and Week 7
Change in HDRS score from Baseline
Hamilton Depression Rating Scale (HDRS)
时间窗: Week 4 and Week 7
Change in HDRS score from Baseline
Blinding Integrity
时间窗: Week 7
Participants will be asked to guess whether they received active or sham treatment, providing a third option of "don't know"
次要结局
- Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR)(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13)
- Response and Remission rates defined by HDRS(Week4, Week 7, Week 10, and Week 13)
- Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13)
- Clinical Global Impression severity (CGI-S) and improvement (CGI-I) subscales(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13)
- Sheehan Disability Scale (SDS)(Baseline, Week 7, and Week 13)
- Montgomery-Asburg Depression Rating Scale (MADRS)(Baseline, Week 7 and Week 13)
- Response and Remission rates defined by HDRS(Week4, Week 7, Week 10, and Week 13)
- Sheehan Disability Scale (SDS)(Baseline, Week 7, and Week 13)
- Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR)(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13)
- Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13)
- Clinical Global Impression severity (CGI-S) and improvement (CGI-I) subscales(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13)
- Montgomery-Asburg Depression Rating Scale (MADRS)(Baseline, Week 7 and Week 13)
研究者
研究点 (2)
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