Ketamine Anesthesia for Improvement of Depression in ECT
关键词
抽象
描述
The purpose of this prospective randomized clinical trial is to determine if patients receiving ketamine as a part of general anesthesia during electroconvulsive therapy (ECT) rather than standard of care will have improvement in symptoms of depression after a course of ECT treatments. The investigators hypothesize that utilization of ketamine for induction of general anesthesia during ECT treatments will improve symptoms of depression better than standard care.
For induction of general anesthesia for ECT, patients will receive either 1mg/kg of methohexital (standard arm) or 1.0 mg/kg IV ketamine (experimental arm) intravenously (IV) for the duration of their ECT index course over 2-3 weeks. The primary outcome in this trial is change in symptoms of depression assessed by standard questionnaires: Patient Health Questionnaire 9 (PHQ9) and Hamilton Depression Rating Scale (HAM-D) score changes from baseline and final ECT administration. Secondary outcomes are changes in cognitive status as assessed by the Montreal Cognitive Assessment (MoCA) scale, quality of seizures and after seizure, changes in serum metabolites (including kynurenine, D/L-serine and other glutamate intermediates) after treatment and need for further ECT courses (relapse) within 1 year after initial course.
Approximately 50 veterans with the diagnosis of major depressive disorder older than 18 years of age undergoing ECT will be randomized and blinded to the intervention. Operative ECT clinicians will not be blinded; clinicians evaluating patients will be blinded. Exclusion criteria for this study include uncontrolled hypertension, blood pressure > 180/90 mmHg at the pre-anesthesia clinic visit, renal failure, neurologic disorders (e.g. epilepsy, space occupying lesions, traumatic brain injuries in the past 6 months), myocardial infarction in the past 6 months, known allergies or adverse reactions to ketamine, American Society of Anesthesiology Physical Class greater than 3, concomitant psychosis, schizophrenia or current abuse of alcohol or illicit substances and pregnancy.
The long term objective of this trial is to systematically characterize ketamine's effect on depression outcomes utilizing validated scoring tools, its safety profile throughout an ECT index course, ketamine's effect on seizure quality and changes in novel translational endpoints to better understand mechanisms of action of ketamine and its potential role in treatment of psychiatric disorders.
日期
| 最后验证: | 05/31/2018 |
| 首次提交: | 03/24/2016 |
| 提交的预估入学人数: | 04/22/2016 |
| 首次发布: | 04/26/2016 |
| 上次提交的更新: | 05/31/2018 |
| 最近更新发布: | 06/05/2018 |
| 实际学习开始日期: | 02/29/2016 |
| 预计主要完成日期: | 03/31/2017 |
| 预计完成日期: | 04/29/2018 |
状况或疾病
干预/治疗
Drug: Ketamine Interventional Arm
Drug: Methohexital Control Arm
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Ketamine Interventional Arm 1.0 mg/kg IV ketamine (experimental arm) intravenously (IV) for the duration of their ECT index course over 2-3 weeks | Drug: Ketamine Interventional Arm Ketamine anesthesia for ECT index course with measurement cerebral metabolic regional oximetry, EEG seizure quality, cognitive scoring and serum metabolites. |
| Active Comparator: Methohexital Control Arm 1mg/kg of methohexital (standard arm) intravenously (IV) for the duration of their ECT index course over 2-3 weeks | Drug: Methohexital Control Arm Methohexital anesthesia for ECT index course with measurement cerebral metabolic regional oximetry, EEG seizure quality, cognitive scoring and serum metabolites. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - outpatients or inpatients at the Puget Sound VA with diagnosis of major depressive disorder or bipolar 1 or 2 over the age of 18 undergoing index course ECT Exclusion Criteria: - uncontrolled hypertension (blood pressure > 180/90 mmHg at the pre-anesthesia clinic visit) - renal failure - neurologic disorders (e.g. epilepsy, space occupying lesions, traumatic brain injuries in the past 6 months) - myocardial infarction in the past 6 months - known allergies or adverse reactions to ketamine - American Society of Anesthesiology Physical Class greater than 3 - concomitant psychosis - schizophrenia or current abuse of alcohol or illicit substances and pregnancy (any trimester) |
结果
主要结果指标
1. Change in Depression Patient Health Questionnaire 9 (PHQ9) Scoring [Change from Baseline Score 24 hours prior to starting ECT to PHQ9 score 72 hours following last ECT session]
次要成果指标
1. Soluble Amino Acid Metabolomic Biomarkers [30 minutes prior to first ECT session and within 30 minutes after final ECT session]
2. ECT Seizure Duration [Length of each intraoperative ECT seizure during an index course typically 6-12 individual seizures measure from start of seizure in operating room to end of seizure in operating room.]
3. Change in Montreal Cognitive Assessment (MoCA) Scoring [Change from Baseline Score 24 hours prior to starting ECT to MoCA score 72 hours following last ECT session]
