跳至主要内容
临床试验/NCT04277936
NCT04277936终止2 期

Pharmacologic Modulation of Hippocampal Activity in Psychosis

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2020年5月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
1
试验地点
1
主要终点
Hippocampal Activity (Arterial Spin Labeling [ASL] Study)

研究概览

简要总结

The purpose of this study is to test whether administration of levetiracetam (LEV), a commonly used anti-epileptic that alters neurotransmitter release, can reduce hippocampal hyperactivity. Specifically, we will utilize two functional magnetic resonance imaging (MRI) techniques: 1) blood oxygen level dependence (BOLD) contrast will assess activity with a visual scene processing task that engages the anterior hippocampus and 2) arterial spin labeling (ASL) will assess baseline activity. This study will also assess whether patients have improvement in their symptoms after receiving LEV. Previous studies in people with psychotic disorders have shown that the hippocampus is hyperactive and more activity correlates with worsening of clinical symptoms. Therefore, the aim of this study is to use an intervention to further understand the underlying mechanisms of the hippocampus in psychosis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Levetiracetam (LEV) 500 mg

Experimental

Participants will take their first dose of 500 mg LEV. After a two hour time window, the participants will complete MRI study. After MRI, patients will begin a 2-week intervention with 250 mg BID oral LEV.

干预措施: Levetiracetam 500 mg (Drug)

结局指标

主要结局

Hippocampal Activity (Arterial Spin Labeling [ASL] Study)

时间窗: 2 hours and 2 weeks after administration

Change in ASL signal after drug administration

Hippocampal Recruitment (BOLD Study)

时间窗: 2 hours and 2 weeks after administration

Change in BOLD signal after drug administration

次要结局

  • Positive and Negative Symptoms(2 weeks after administration)
  • Cognitive Symptoms(2 weeks after administration)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephan Heckers

Department Chair

Vanderbilt University Medical Center

研究点 (1)

Loading locations...

相似试验