Glutamatergic System and Response to Clozapine in Patients With Treatment-Resistant Schizophrenia: a Prospective Proton Magnetic Resonance Spectroscopy Study
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change in 1H-MRS glutamatergic metabolites before and after clozapine.
研究概览
简要总结
The purpose of this study is to investigate the relationship between glutamate and related brain chemicals and treatment response to clozapine in patients with treatment-resistant schizophrenia.
详细描述
This study will be a prospective proton spectroscopy (1H-MRS) study designed to compare the levels of glutamate, glutamine, glx, and glutathione in age- and gender- matched patients with poor response to clozapine (URS), patients with good response to clozapine (non-URS), and healthy controls. Participants with schizophrenia who fail to respond to optimal treatment with at least two different non-clozapine antipsychotics (i.e. treatment-resistant schizophrenia [TRS]) and who are starting clozapine as part of their clinical care will be recruited. A sample of healthy controls will also be recruited. Participants with TRS will have two 1H-MRS scans. The 1H-MRS scan will be performed within 1 week and 12 weeks after clozapine initiation. Clinical assessments will be performed within 1 week of each 1H-MRS scan and after 6 weeks of clozapine treatment. Cognitive assessments will also be performed within 1 week of 1H-MRS scans. Healthy controls will also undergo two 1H-MRS scans with a 12-week interval. Cognitive assessments will also be performed within 1 week of 1H-MRS scans.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
Clozapine Responders (Non-URS)
Definition of non-URS
(1) ≥30% decrease in the PANSS positive subscale score, CGI-severity ≤3 and CGI-Improvement ≤2 after 12 weeks of treatment.
干预措施: Clozapine (Drug)
Clozapine Non-Responders (URS)
Definition of URS
- Taking clozapine for ≥ 12 weeks, attaining a plasma clozapine level ≥350 ng/ml.
- CGI-Severity score of ≥4 and score of ≥4 on 2 PANSS positivesymptom items.
干预措施: Clozapine (Drug)
结局指标
主要结局
Change in 1H-MRS glutamatergic metabolites before and after clozapine.
时间窗: Change from baseline (pre-clozapine) of 1H-MRS glutamatergic metabolites at 12 weeks
1H-MRS will be employed to quantify glutamatergic metabolites, specifically glutamate, glutamine, glx and glutathione.
次要结局
未报告次要终点
研究者
Ariel Graff
Ariel Graff MD, PhD
Centre for Addiction and Mental Health