An Open Label Home-administered Transcranial Direct Current Stimulation (tDCS) Clinical Trial of Unipolar Depression
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Mood
研究概览
简要总结
This study will determine the safety and efficacy of home administered tDCS in adults with unipolar depression. The device used to administer tDCS will be the Soterix Medical 1X1 mini-CT. 32 tDCS sessions of 30 minutes each will be delivered over 10 weeks.
详细描述
The Soterix Medical 1X1 mini-CT will be used to determine the safety and efficacy of home-based transcranial direct current stimulation (tDCS) in treating unipolar depression. Specifically efficacy will be determined by change in MADRS score from baseline to the 10 week follow-up. Feasibility and compliance will be determined by low drop out rate and percentage of scheduled sessions completed. Self-reported mood scores will be evaluated using the Quick Inventory of Depressive Symptomatology (QIDS-SR) and Quality of Life enjoyment and Satisfaction Questionnaire Form (Q-LES-Q-SF). All visits will be performed via telephone or video conference. Subjects will be taught to operate the tDCS system and complete a tolerability check. The treatment course will consist of an acute phase of 28 tDCS sessions conducted Monday - Friday over 6 weeks. This is followed by a taper of 4 tDCS sessions spaced 1 week apart. Patients who meet criteria for clinical response (>=50% improvement in MADRS) may continue with maintenance treatments of once a week for 2 months and once every 2 weeks for the remaining 3 months. Mood assessments will be conducted at baseline, 2 weeks, 4 weeks and 6 weeks in the acute treatment phase. In the taper phase, assessments wil be conducted at 1 month (end of taper), 3 and 6 months following completion of the acute phase. All assessments in the acute treatment phase and the taper phase will have a +/- 1 week collection window.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 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
- •Scored at least 20 on the MADRS at trial entry
- •Patient's antidepressant medication is stable for at least 30 days prior to MADRS screening
- •Female patients are allowed if not pregnant and are using a medically acceptable method of contraception, if of childbearing potential
排除标准
- •DSM-V-TR psychotic disorder
- •Drug or alcohol abuse or dependence in the preceding 3 months
- •Concurrent benzodiazepine medication
- •High suicide risk
- •History of clinically defined neurological disorder or insult
- •Metal in the cranium or skull defects
- •Subjects with an 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
Active Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator
干预措施: Soterix Medical mini-CT tDCS stimulator (Device)
结局指标
主要结局
Change in Mood
时间窗: Baseline, at the end of Weeks 2, 4 ,6 during the acute phase, at completion of taper phase (end of Week 10) and during the Follow-up period (end of Weeks 18 and 30)
Mood will be assessed with the Montgomery Asberg Depression Rating Scale (MADRS). Patients who meet criteria for clinical response (\>=50% improvement in MADRS) may continue with maintenance treatments of once a week for 2 months and once every 2 weeks for the remaining 3 months.
次要结局
- Quick Inventory of Depressive Symptomology (QIDS-SR)(Weeks 1-10. Patients who receive maintenance sessions will also report at the end of Weeks 11-18, 20, 22, 24, 26, 28, 30)
- Self-Reported Mood Score(Weeks 1-10. Patients who receive maintenance sessions will also report before sessions 33-46 (Weeks 11-30))
- Quality of Life Enjoyment and Satisfaction Questionnaire Form (Q-LES-Q-SF)(Weeks 1-10. Patients who receive maintenance sessions will also report at the end of Weeks 11-18, 20, 22, 24, 26, 28, 30)
- Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline, at the end of Weeks 2, 4 ,6 during the acute phase, at completion of taper phase (end of Week 10) and during the Follow-up period (end of Weeks 18 and 30))
- Self-report Columbia Suicide Severity Rating Scale (C-SSRS)(Weeks 1-10)
- Adverse Effects: Pain(Weeks 1-10)
- Adverse Effects: Suicidal Ideation(Weeks 1-10)