The Role of Glutamatergic Function in the Pathophysiology of Treatment-resistant Schizophrenia
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Change in glutamate levels (using magnetic resonance spectroscopy) pre- and post-riluzole administration
研究概览
简要总结
The goal of this basic science study is to to explore the responsivity of glutamate in the brain of treatment-resistant schizophrenia patients to the drug riluzole. The main aims of the study are:
To assess the role of glutamate in treatment-resistant schizophrenia using magnetic resonance spectroscopy.
To assess the relationship between glutamate levels and brain structural and functional measures (using: structural MRI; functional MRI (fMRI) and arterial spin labelling (ASL)) at baseline.
To assess the relationship between longitudinal change in glutamate levels and brain structural and functional measures.
To assess the relationship between longitudinal change in glutamate levels and changes in psychopathology.
The researchers will compare the changes with healthy controls and those without treatment-resistant schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment-resistant schizophrenia patients receiving riluzole
干预措施: Riluzole (Drug)
结局指标
主要结局
Change in glutamate levels (using magnetic resonance spectroscopy) pre- and post-riluzole administration
时间窗: Brain measurements will be conducted at baseline (day -7 to day -1 before riluzole administration), day 7 and day 56 (+- 14 days)
Change in glutamate levels will be assessed (using magnetic resonance spectroscopy) in treatment-resistant schizophrenia patients compared with controls and patients without treatment-resistant schizophrenia
次要结局
- Correlation of glutamate (using magnetic resonance spectroscopy) with brain functional measures at baseline (using functional magnetic resonance imaging)(Brain measurements will be conducted at baseline (day -7 to day -1 before riluzole administration), day 7 and day 56 (+- 14 days))
- Longitudinal change in glutamate levels (using magnetic resonance spectroscopy) correlated with changes in psychopathology(Brain measurements will be conducted at baseline (day -7 to day -1 before riluzole administration), day 7 and day 56 (+- 14 days))
- Longitudinal change in glutamate levels (using magnetic resonance spectroscopy) correlated with longitudinal change in brain functional measures (using functional magnetic resonance imaging)(Brain measurements will be conducted at baseline (day -7 to day -1 before riluzole administration), day 7 and day 56 (+- 14 days))