Deciphering Metacognition and Treatment Response in Depression With a Novel Digital Paradigm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical remission
研究概览
简要总结
To develop and test a neurocomputational model of ketamine treatment response predictions in TRD.
详细描述
The investigators propose applying a previously validated computational model of the MMN and the ensuing effects of NMDAR antagonism to predict treatment response following ketamine infusions in TRD patients and distinguish ketamine's antisuicidal effects from those related to mood improvements. The study has two subgoals: first, the computational mechanisms underlying MMN reductions that predict ketamine treatment response in TRD patients will be examined. Second, the computational mechanisms will be linked to their underlying neural causes using neural circuit models. Beyond understanding ketamine's short- and long-term mechanisms of action in TRD, the parameters obtained from fitting these models to noninvasive EEG recordings may facilitate single-patient treatment predictions. If successful, this approach may provide clinically useful prognostic statements in individual patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •1.18 to 65 years of age
- •Meeting Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria for MDD and in a Major Depressive Episode and ≥10 on the Montgomery-Asberg Depression Rating Scale (MADRS).
- •Competent to consent-based on their ability to provide a spontaneous narrative description of the key elements of the study.
- •Failure of at least two trials of antidepressant therapy during the current episode (treatment-resistant depression) and receiving ketamine treatment clinically as administered by their clinician
- •Staying on stable dosages of any concomitant psychotropic medications.
排除标准
- •History of bipolar disorder or psychosis
- •Current substance use or history of substance use during the past year (excluding nicotine and caffeine use disorder)
- •Concomitant major and unstable medical or neurologic illness or a history of seizures.
- •Non-English-speaking individuals.
结局指标
主要结局
Clinical remission
时间窗: 4 weeks following the baseline visit
Remission, defined as MADRS \<10, and suicide risk reduction is defined as a ≥ 50% reduction in the suicidal ideation item of the MADRS scale from baseline
次要结局
- Modelling(2 weeks following the baseline visit)