Cognitive Therapy to Sustain the Antidepressant Effects of Intravenous Ketamine in Treatment-resistant Depression: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Time to relapse of depression measured by the Montgomery-Asberg Depressive Rating Scale (MADRS) score.
研究概览
简要总结
The goals of this study are: 1) to investigate the efficacy of combining ketamine with intensive cognitive behavioral therapy (CBT) to sustain the antidepressant effects of ketamine; and 2) to determine ketamine's delayed effects on learning and memory, and to explore the relationship between any ketamine-induced changes in learning and memory and duration of antidepressant efficacy, with and without CBT augmentation. Subjects with a diagnosis of MDD who are treatment-resistant to at least 2 antidepressants and have chosen to pursue clinical ketamine treatment at Yale Psychiatric Hospital will be recruited for the study.
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
- Single (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
- •Suffering from a major depressive episode based on Diagnostic and Statistical manual (DSM) 5 criteria and having failed one or more standard antidepressant treatments during the current episode
- •Hamilton Depression Rating Scale (17-HAM-D) score of 21 or more prior to ketamine treatment.
- •Planned clinical treatment with ketamine at Yale Psychiatric Hospital (YPH)
- •As the purpose of this study is to determine the feasibility and efficacy of CBT to sustain the antidepressant effects of ketamine, only those who achieve a clinical response (i.e., 50% reduction in depression symptoms, as measured by the Montgomery-Asberg Depressive Rating Scale (MADRS) will be eligible for randomization.
- •Patients must be treatment resistant to at least two drugs used to treat depression.
排除标准
- •Any Axis I or Axis II Disorder, which at screening is clinically predominant to their depressive episode or has been predominant to their depressive episode at any time within 6 months prior to screening
- •Active suicidal thoughts with a plan
- •Current or recent (<6 months ago) substance use disorder
- •Non-affective psychosis (such as schizophrenia or schizoaffective disorder)
- •Inability to speak English fluently
- •A clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results
- •Dementia, delirium, or any other neurological or mental disease that might affect cognition or the ability to meaningfully participate in cognitive behavioral therapy (CBT).
结局指标
主要结局
Time to relapse of depression measured by the Montgomery-Asberg Depressive Rating Scale (MADRS) score.
时间窗: Enrollment to 17 week follow-up
Relapse is defined as less than 50% improvement in MADRS compared to baseline MADRS score. The median time to relapse is the time at which the 50th percentile of participants relapses.
次要结局
- Change in cognitive flexibility-executive function(Before the first ketamine treatment and 24 hours following the last ketamine treatment.)
- Change in cognitive flexibility-working memory(Before the first ketamine treatment and 24 hours following the last ketamine treatment.)