Neurocognitive Features of Patients With Treatment-Resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Change in pattern separation task results
研究概览
简要总结
There is an urgent need for novel and effective interventions for treatment-resistant depression (TRD). In previous studies, ketamine has been shown to rapidly reduce depressive symptoms; however, the exact mechanisms of action of ketamine remain unknown. There are some preliminary findings to suggest that ketamine may exert its antidepressant effects through promotion of neurogenesis in the dentate gyrus. The aim of this study is to help delineate the neurocognitive effects of ketamine exposure using a behavioral task (specifically, a pattern separation task) and a battery of other well-established cognitive measures.
This is an assessment-only study, as we will be recruiting subjects to complete an assessment battery at two time points, before and after receiving ongoing ketamine administrations for at least four weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be 18-80 years old
- •be able to read, understand, and provide written informed consent in English,
- •meet criteria for a current moderate/severe (> 14 on QIDS-SR) depressive episode (unipolar or bipolar mood disorder),
- •have a history of > 3 failed antidepressant trials, and be
- •be seeking ketamine ongoing treatment through the ketamine clinic at Massachusetts General Hospital and be deemed appropriate for the clinic.
排除标准
- •Subjects who will not provide consent to neuropsychological testing
- •Subjects who are not deemed appropriate for the ketamine clinic will not be enrolled
结局指标
主要结局
Change in pattern separation task results
时间窗: Baseline - post at least 2 weeks on a stable dose of intranasal ketamine
The pattern separation task is a computer-based behavioral task that captures characteristic of pattern separation processes. Pattern separation is thought to be involved in the process of you finding your car everyday despite being in a different space; this may be dysfunctional in people with depression. The task itself is not an intervention; it is a rapid assessment of putative changes in pattern separation.
次要结局
未报告次要终点
研究者
Cristina Cusin, MD
Staff Psychiatrist
Massachusetts General Hospital