Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression (CLACS): Single-Site Open-Label Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in Hamilton Depression Rating Scale 17-item (HDRS-17)
研究概览
简要总结
The purpose of this research study is to study closed-loop transcranial alternating current stimulation (tACS) to determine its effects on symptoms of depression in people with major depressive disorder.
详细描述
The purpose of this clinical trial is to investigate the preliminary efficacy of closed-loop tACS for the treatment of major depressive disorder (MDD) in an open-label pilot study. We will recruit up to 35 participants with unipolar, non-psychotic MDD. Participation will include seven visits, two of them remotely (with an in-person option as needed), and one electronic survey.
Potential participants fill-in an electronic pre-screening form. If potentially eligible, a remote screening visit is performed. If eligible, participants attend five consecutive, daily stimulation sessions. Clinical assessments will be performed at baseline (Day 1 of stimulation, D1), Day five of stimulation (D5), and at their follow-up visit (14 days after the completion of stimulation, FU2) using the Hamilton Depression Rating Scale (HDRS-17).
For a subset of patients, electroencephalography (EEG) is collected at D1 prior to stimulation and after stimulation and again at FU2.
For a subset of patients, self-scoring surveys will be sent bi-weekly until 12 weeks after treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-70 years
- •Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosis of MDD; unipolar, non-psychotic
- •Hamilton Rating Depression Rating Scale (HRDS-17) score >8
- •Low suicide risk as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) triage form (no intent or plan)
- •Capacity to understand all relevant risks and potential benefits of the study (informed consent)
排除标准
- •DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months.
- •DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months.
- •Lifetime history of bipolar disorder, psychotic disorder, schizophrenia, autism
- •Current use of benzodiazepines > 20mg diazepam/d equivalent
- •Antidepressant dose change within the last 2 weeks
- •Initiated new antidepressant within the last 4 weeks
结局指标
主要结局
Change in Hamilton Depression Rating Scale 17-item (HDRS-17)
时间窗: Day 1 to Day 19 (i.e. 19 days)
Change in HDRS-17 from Day 1 (D1) to Day 19 (i.e., two week follow-up; FU2); HDRS-17 minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. Negative scores indicate improved outcomes.
次要结局
- Change in Hamilton Depression Rating Scale 17-item (HDRS-17)(Day 1 to Day 5 (i.e., 5 days))
- Response/Remission of Depression(Day 5 and Day 19)
- Change in Quick Inventory of Depressive Symptomatology (QIDS)(Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2))
- Change in Altman Self-Rating Mania Scale (ASRM)(Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2))
- Change in Snaith-Hamilton Pleasure Scale (SHAPS)(Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2))
- Change in Depression Anxiety and Stress Scale (DASS-42)(Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2))
- Change in State-Train Anxiety Inventory (STAI)(Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2))
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF)(Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2))
- Change in Clinical Global Impression Scale (CGI)(Severity: {Day 1 (D1), Day 5 (D5) and Day 19 (FU2)}; Global Improvement: {Day 5 (D5) and Day 19 (FU2)})