A Randomized Pilot Study Examining DCEEG Characteristics in Ketamine Versus Methohexital Induction in Depressed Patients Receiving Electroconvulsive Therapy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Participants Assessed for Clinical Efficacy of ECT
研究概览
简要总结
The investigators will be examining slow-wave characteristics in depressed patients receiving electroconvulsive therapy (ECT) using direct current electroencephalogram (dcEEG) by anesthesia induction agent.
详细描述
This is a pilot project using dcEEG to look at infra-slow waves in depressed patients receiving ECT randomized to ketamine or methohexital where ketamine suppresses infra-slow waves. The rationale for this project is to identify biomarkers of treatment adequacy in ECT, which could lead to decreased morbidity and mortality with the procedure and lessen the burden of depression in our patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, 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
- •Structured Clinical Interview for DSM-5 will confirm diagnosis of MDD or BPD-depressed (with or without psychotic features
- •The clinical indications for ECT including treatment resistance or a need for a rapid and definitive response;
- •Hamilton Depression Rating Scale 24-item (HDRS-24) > 21; and
- •Age range between 18 and 65 years of age.
排除标准
- •Defined neurological or neurodegenerative disorder (e.g., history of head injury with loss of consciousness > 5 minutes, epilepsy, Alzheimer's disease);
- •Other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
- •Current drug or alcohol use disorder, except for nicotine and marijuana
- •Adults unable to consent, pregnant women, prisoner
- •Non-English speakers
- •Patients that cannot tolerate Methohexital and Ketamine.
研究组 & 干预措施
Ketamine
Standard of care anesthesia that suppresses slow wave characteristics
干预措施: Ketamine (Drug)
Methohexital
Standard of care anesthesia that does not affect slow wave characteristics
干预措施: Methohexital (Drug)
结局指标
主要结局
Number of Participants Assessed for Clinical Efficacy of ECT
时间窗: 1 year
Quick Inventory of Depressive Symptomatology (QIDS) and Self Reporting version (QIDS-SR) - Range 0 - 48 with higher number indicating worsening depression. Inadequate sample size due to COVID. Study was closed.
次要结局
未报告次要终点
研究者
Jeremy Miller
Attending Psychiatrist
University of New Mexico