N-methyl-D-aspartate Antagonist (Ketamine) Augmentation of Electroconvulsive Treatment for Severe Major Depression
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Rating Scale - 28
研究概览
简要总结
Electroconvulsive therapy (ECT), is considered the most effective treatment for severe treatment resistant major depressive disorder (MDD), but it requires about 3 weeks of treatments and can cause considerable acute deficits in memory. It would be a major advance in treatment if ECT could work faster with fewer treatments and result in decrease incidence of memory problems. Ketamine is an excellent candidate for augmentation of ECT because of its acute effects on depression, its short half-life, and its safety profile when given at low doses. Ketamine is given as an infusion and could easily be incorporated into the routine management of patients undergoing ECT, but has never been evaluated prospectively in this context.
The investigators propose to assess the efficacy, feasibility, tolerability and safety of N-methyl-D-aspartate antagonist augmentation of ECT using ketamine.
详细描述
Aim #1: To assess the efficacy of ketamine augmentation in reducing time to remission of a major depressive episode (MDE).
Aim #2: To assess the efficacy of ketamine augmentation on ECT-related cognitive side effects.
Aim #3: To assess the feasibility, safety, and tolerability of ketamine augmentation of ECT.
Exploratory aim #4: We propose to assess the patterns of functional connectivity before, during and after ECT using standard clinical EEG to better characterize the effect of ECT and to correlate clinical effects with changes in EEG measurements.
Thirty (30) participants will be recruited over 24 months. Participants will be males and females, ages 18-60, with severe MDD (baseline score HAM_D-28 >= 20) deemed appropriate for ECT treatment by their treating physician, agreeing to receive ECT treatment as part of their clinical care, and able to provide informed consent.
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, Investigator)
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
- •males and females between the ages of 18-65,
- •DSM-IV diagnosis of Major Depressive Disorder (MDD), without psychotic features
- •HAM-D-28 score of 20 or higher
- •requiring ECT treatment as part of their psychiatric care Comorbid anxiety disorders (OCD, Generalized anxiety, panic disorder) will be allowed as long as the clinician administering the SCID believes that they are not the primary diagnosis.
排除标准
- •MDD with a score of <20 on the HAM-D 28,
- •Other DSM-IV primary diagnoses including major depressive disorder with psychotic features, bipolar disorder, schizoaffective disorder, schizophrenia, dementia
- •any history of psychosis
- •substance use disorder (abuse or dependence with active use within the last 6 months), and any lifetime history of ketamine abuse or dependence;
- •organic mental disorders;
- •seizure disorder or chronic antiepileptic medications;
- •severe or unstable medical illness, including history of closed head injury resulting in loss of consciousness, medical contraindication to anesthesia or to ECT (i.e. recent myocardial infarction, increased intracranial pressure)
- •current treatment with memantine
- •pregnancy, or females of reproductive age who are not using an accepted method of contraception (birth control pill, IUD, combination of barrier methods).
- •known hypersensitivity to ketamine
研究组 & 干预措施
ketamine
ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week
干预措施: ketamine (Drug)
ketamine
ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week
干预措施: ECT (Procedure)
ketamine
ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week
干预措施: Muscle Relaxant (Drug)
ketamine
ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week
干预措施: Anesthetic Agents (Drug)
placebo
IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.
Right unilateral ECT at 5-6x seizure threshold three times a week
干预措施: IV Saline (Other)
placebo
IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.
Right unilateral ECT at 5-6x seizure threshold three times a week
干预措施: ECT (Procedure)
placebo
IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.
Right unilateral ECT at 5-6x seizure threshold three times a week
干预措施: Muscle Relaxant (Drug)
placebo
IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.
Right unilateral ECT at 5-6x seizure threshold three times a week
干预措施: Anesthetic Agents (Drug)
结局指标
主要结局
Change in Hamilton Depression Rating Scale - 28
时间窗: baseline, one month
HAMD will be administered at every ECT treatment.The HAM D 28 is a 28 item scale with scores ranging from 0 to 83, with 0 being no depression and 83 being high levels of depression symptoms. The change in HAM S score was determined by the difference of the HAM D score at the last ECT administration and the baseline HAM D score. A negative change score reflects a decreased HAM D score between the first and last ECT administration and therefore a reduction in depressive symptoms.
次要结局
- Number of Participants With Cognitive Side Effects(3 months)
研究者
Cristina Cusin, MD
Instructor HMS
Massachusetts General Hospital