Lorazepam Effects on Neuroimaging Measures: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To understand the impact of lorazepam on functional connectivity measures collected using resting state functional magnetic imaging (rs-fMRI).
研究概览
简要总结
This within-subject, double blind, randomized controlled study will investigate the effects of a widely used benzodiazepine (BZD), lorazepam, on various neuroimaging measures. The investigators will be assessing the relationship of lorazepam to resting state functional connectivity and other neuroimaging measures. Specifically, the investigators will be using a pre-identified metric, the striatal connectivity index (SCI), (Sarpal et al. 2015, 2016), a prognostic biomarker of treatment response assessing the connectivity between regions of the striatum and the cortex. The investigators hypothesize that lorazepam administration will be associated with greater SCI values compared with placebo administration; consistent with previous work suggesting short-acting benzodiazepines increase functional connectivity across brain networks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18-40
- •In general good health as evidenced by medical history
- •Ability to take oral medication and be willing to adhere to the study medication regimen
- •For women of reproductive potential, negative pregnancy test and agreement to use a medically accepted birth control method.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Pregnancy or lactation
- •Contraindications to MR imaging (i.e. pacemaker)
- •Known allergic reactions to components of the lorazepam
- •Current smoker or tobacco use
- •Concurrent use of any psychotropic medications, anticonvulsants, opioids or any other medication with effects on the CNS.
- •Acute narrow-angle glaucoma
- •Current or past history of a substance use disorder and/or a positive urine toxicology test.
研究组 & 干预措施
Lorazepam first
This arm comprises of participants who were randomized to receive lorazepam 1 mg prior to the first MRI scan and then placebo on the second MRI scan a week later.
干预措施: Lorazepam 1Mg Tablet (Drug)
Lorazepam first
This arm comprises of participants who were randomized to receive lorazepam 1 mg prior to the first MRI scan and then placebo on the second MRI scan a week later.
干预措施: Placebo (Drug)
Placebo first
This arm comprises of participants who were randomized to receive placebo prior to the first MRI scan and then lorazepam 1 mg orally prior to the second MRI scan a week later.
干预措施: Lorazepam 1Mg Tablet (Drug)
Placebo first
This arm comprises of participants who were randomized to receive placebo prior to the first MRI scan and then lorazepam 1 mg orally prior to the second MRI scan a week later.
干预措施: Placebo (Drug)
结局指标
主要结局
To understand the impact of lorazepam on functional connectivity measures collected using resting state functional magnetic imaging (rs-fMRI).
时间窗: 2 weeks
SCI, a parameter that captures the connectivity between the stratum and the cortex, is a primary candidate for a prognostic biomarker that may guide individual treatment. Exploratory functional connectivity analyses between other brain regions will be conducted as well.
次要结局
- The goal is to study the impact of lorazepam on glutamate, glutamine and GABA in the striatum.(2 weeks)
研究者
Juan Gallego Angel
Assistant Investigator
Northwell Health