A Proof of Concept Randomized Controlled Trial of XEN1101 for the Treatment of Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in activation within the reward circuit by fMRI
研究概览
简要总结
This project is designed to examine the neuronal KCNQ2/3 potassium (K+) channel subtype as a novel treatment target for mood disorders through the administration of the KCNQ-selective channel opener XEN1101 (Xenon Pharmaceuticals).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
XEN1101
Subjects will take two 10 mg capsules of XEN1101 daily for 8 weeks for a total daily dose of 20 mg.
干预措施: XEN1101 (Drug)
Placebo
Subjects will take a matching placebo daily for eight weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in activation within the reward circuit by fMRI
时间窗: Baseline (week 0), End of treatment (week 8)
The change in activation within the bilateral ventral striatum (VS) from baseline (week 0) to end of treatment (week 8) as measured by fMRI during an Incentive Flanker Task.
次要结局
- Change in Montgomery-Åsberg Depression Rating Scale Score(Baseline (week 0), End of treatment (week 8))
- Change in Quick Inventory of Depressive Symptomatology, Self-Report [QIDS-SR] Score(Baseline (week 0), End of treatment (week 8))
- Change in Temporal Experience of Pleasure Scale(Baseline (week 0), End of treatment (week 8))
- Change in Snaith-Hamilton Pleasure Scale (SHAPS)(Baseline (week 0), End of treatment (week 8))
- Change in Clinical Global Impression Scale(Baseline (week 0), End of treatment (week 8))
研究者
James Murrough
Associate Professor, Psychiatry
Icahn School of Medicine at Mount Sinai