A Randomized Comparison of Ketamine and Methohexital Anesthesia for Electroconvulsive Therapy (ECT) in Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Mean Depression Rating Using the Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
Does the use of ketamine as the anesthetic medication in electroconvulsive therapy (ECT) accelerate the antidepressant effect of ECT?
The study hypothesis was that depressed subjects receiving ECT with ketamine as the anesthetic agent would demonstrate a faster rate of improvement, defined as lower depression ratings after the second ECT than depressed patients receiving ECT with the usual anesthetic agent.
详细描述
There are several drugs available to induce anesthesia for electroconvulsive therapy (ECT), a psychiatric treatment for major depressive illness. The most commonly utilized of these include methohexital, thiopental, etomidate, and propofol. Recently, there has been interest in the use of ketamine in sub-anesthetic doses to treat major depressive illness.
In this randomized, blinded trial, depressed subjects scheduled to be treated with ECT were anesthetized with either ketamine or methohexital at doses of approximately 1.0 mg/kg for each drug. Patients received the same drug for up to six of their ECT treatments. Outcome measures included assessments of depressive severity, cognition, post-anesthesia side effects, and hemodynamics.
Subjects were to be followed with as long as they were receiving inpatient ECT treatments. The number of treatments was determined entirely by their primary psychiatric team, also blind to anesthetic, as per usual care. In other words, this study did not determine when to terminate the ECT course.
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
- Double (Participant, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ketamine
Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
干预措施: Ketamine (Drug)
Methohexital
Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
干预措施: methohexital (Drug)
结局指标
主要结局
Mean Depression Rating Using the Hospital Anxiety and Depression Scale (HADS)
时间窗: Baseline and after every second treatment for 7 treatments
The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 42 (severe symptoms) for either anxiety or depression. The questionnaire was administered to the subjects prior to the first treatment, the morning of the third treatment, the morning of the fifth treatment, and the morning of the seventh treatment. For subjects whose treatment series ws cancelled prior to a scheduled next administration of the rating scale, every effort was made to administer them 2 days after the last treatment. Means are reported overall across all treatments; p-values also take into account variability across treatments and within subject.
次要结局
- Mean Depression Rating Using the Patient Health Questionnaire-9 (PHQ-9)(Baseline and after every second treatment for 7 treatments)
- Mean Post Anesthesia Recovery Side Effects(Time of discharge from recovery after ECT for each treatment, approximately 30 minutes after the end of the seizure)