Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment on Alternate Week Days in Patients With Treatment Resistant Depression: A Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion
研究概览
简要总结
In this proof of concept study, the investigators plan to administer iv ketamine interleaved with ECT days.
Patients with treatment resistant depression who are deemed to be eligible for ECT treatment will randomly be assigned to either ketamine or active placebo.
详细描述
The study will compare the effects of standard ketamine dosing with an active placebo arm.
Hypothesis 1:
The investigators hypothesize that interleaved Electroconvulsive Treatment and active ketamine treatment will lead to a meaningful clinical improvement compared to Electroconvulsive Treatment and placebo treatment arm.
Hypothesis 2:
The investigators hypothesize that interleaved Electroconvulsive Treatment and active ketamine treatment will attenuate cognitive side effects.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Males/females at least 18 years of age but no older than 65 years of age
- •Meet Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Major Depression or Bipolar Disorder, depressed phase, as determined by a clinician's diagnostic evaluation and confirmed by interview using the Mini International Neuropsychiatric Interview (MINI PLUS 5.0.0)
- •A current depressive episode that has lasted a minimum of 4 weeks.
- •Have > 3 trials of antidepressants/augmentation strategies.
- •Have a support system capable of transporting the patient post-treatment.
排除标准
- •Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder.
- •Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for other substance/alcohol dependence within the past 6 months or abuse in the past 3 months.
- •Patients who meet exclusion criteria for ketamine and/or midazolam infusion.
研究组 & 干预措施
Ketamine Infusions
Subjects who are randomized to be on this group will receive a standard dose of ketamine interleaved with Electroconvulsive Treatments.
干预措施: Ketamine (Drug)
Midazolam
Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
干预措施: Midazolam (Drug)
结局指标
主要结局
Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion
时间窗: visit 17
Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60
Hamilton Depression Rating Scale (HAMD-17) at Last Infusion
时间窗: visit 17
Change in HAMD-17 at Infusion 6. Scores range from 0 to 50, with higher scores representing more depression.
次要结局
- Controlled Oral Word Association Test (COWAT) at Last Infusion(visit 17)
- Hopkins Verbal Learning Test - Revised (HVLT-R) at Last Infusion(visit 17)
- Montreal Cognitive Assessment (MOCA) at Last Infusion(visit 17)
- Responder Rate on HAMD-17 by Last Infusion(visit 17)
研究者
Dr. Murat Altinay
Staff
The Cleveland Clinic