Behavioral and Electrophysiological Effects of Ketamine in Treatment-Resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feedback-related positivity (FRP) amplitudes over frontocentral scalp regions in response to rewarded trials versus no-reward trials
研究概览
简要总结
The overarching goal of the present study is to evaluate the effect of a subanesthetic dose of ketamine 24-hour post-injection on resting state functional connectivity, cognitive control, and reward learning.
详细描述
Major Depressive Disorder (MDD) participants with treatment-resistant depression (TRD) will be recruited from McLean's Ketamine clinic. Suitability for Ketamine treatment will be determined as typically done by the service - through evaluation by the clinicians on the staff of the Ketamine Service who perform psychiatric consultations and assessments for Ketamine suitability. Potential subjects will be informed about the study only after they have received a positive consultation at the clinic and have already agreed to receive the treatment.
This study consists of a set of questionnaires, urine drug screen, and electroencephalogram (EEG) recordings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Feedback-related positivity (FRP) amplitudes over frontocentral scalp regions in response to rewarded trials versus no-reward trials
时间窗: Baseline
Relative FRP response is the primary outcome measure for the probabilistic reward task (PRT).
Behavioral Performance on the Probabilistic Reward Task (PRT)
时间窗: Baseline
The Probablilistic Reward Task operationalizes positive reinforcement learning
Event-related negativity (ERN) amplitudes over frontocentral scalp regions in response to correct trials versus incorrect trials.
时间窗: Baseline
Relative ERN response is the primary outcome measure for the flanker task.
Behavioral Performance on the Flanker Task
时间窗: Baseline
The Flanker Task is a cognitive task that measures response inhibition to assess the ability to suppress responses that are inappropriate in a particular context.
Rumination
时间窗: Baseline
Severity of rumination will be assessed using the Rumination Response Scale (RRS). The RRS has a minimum score of 22 and a maximum score of 88. Higher scores indicate higher degrees of ruminative symptoms.
次要结局
未报告次要终点
研究者
Diego Pizzagalli
Director, Center for Depression, Anxiety and Stress Research
Mclean Hospital