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临床试验/NCT06159322
NCT06159322招募中不适用

A Study Investigating the Relationship Between the Antipsychotic Response and Non-invasive Proxies of Neurochemistry in Schizophrenia

The Royal Ottawa Mental Health Centre1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Neuromelanin-sensitive magnetic resonance imaging (MRI) contrast-to-noise ratio (CNR)

研究概览

简要总结

The goal of this research project is to develop MRI-based biomarkers to identify patients with schizophrenia who are most likely to benefit from first-line antipsychotic or clozapine treatment. The MRI sequences (NM-MRI, MRS and rsfMRI) will be created by translating the best scientific evidence into a potential clinical product that has the highest chance of being clinically relevant predictor of treatment response. This study has the potential to significantly improve patient outcomes and reduce unnecessary interventions and costs at the Royal's Integrated Schizophrenia Recovery Program.

详细描述

Currently, we cannot predict who will get better on first-line antipsychotic versus clozapine treatment. Although much evidence shows that dopamine and glutamate function are related to treatment response in schizophrenia, the utility of neuromelanin sensitive MRI (NM-MRI) as a measure of dopamine and magnetic resonance spectroscopy (MRS) as a measure of glutamate & glycine (a co-agonist of glutamate receptors) in predicting response to treatment have never been measured in the same sample. The evidence suggests that the function of these two neurotransmitter systems partially determines the response to antipsychotic medications. Additionally, an emerging type of resting-state functional MRI (rsfMRI), naturalistic movie-watching, has been shown to outperform traditional rsfMRI for functional connectivity-based prediction of behaviour and will be explored in the current study. Given the background information, our hypotheses are:

1.1) First-line antipsychotic users will have higher dopamine turnover resulting in a higher NM-MRI signal in the substantia nigra relative to clozapine users.

1.2) First-line antipsychotic users will have lower glutamate and/or glycine concentration as indicated by the MRS signal in the dorsal anterior cingulate relative to clozapine users.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Are voluntary and competent to consent to the study
  • Are between the ages of 18-55
  • Are English literate
  • Have a diagnosis of schizophrenia or schizoaffective disorder
  • Are currently taking primarily olanzapine or clozapine

排除标准

  • Medication for the treatment of schizophrenia or schizoaffective disorder has changed in the past month
  • Have a significant neurologic, neurodevelopmental, cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, or metabolic-endocrine disorder
  • Are pregnant or breastfeeding
  • Acquire positive urine test result for all drugs of abuse including cannabis
  • Have met DSM-5 criteria for substance use disorder other than tobacco in the last 6 months
  • Have a history of significant head trauma with loss of consciousness for more than 5 minutes
  • Have any contraindication to MRI
  • Have any other condition that in the opinion of the investigator(s) could create a hazard to the subject's safety, endanger the study procedures, or interfere with the interpretation of study results

研究组 & 干预措施

First-line treatment group

This group will consist of 20 patients with schizophrenia or schizoaffective disorder who are primarily prescribed olanzapine. Treatment will be carried out by the physicians within their circle of care, however, we will record their symptoms as they continue treatment.

干预措施: Olanzapine (Drug)

Treatment-resistant group

This group will consist of 20 patients with schizophrenia or schizoaffective disorder who are primarily prescribed clozapine due to poor treatment response to first-line antipsychotic agents. Treatment will be carried out by the physicians within their circle of care, however, we will record their symptoms as they continue treatment.

干预措施: Clozapine (Drug)

结局指标

主要结局

Neuromelanin-sensitive magnetic resonance imaging (MRI) contrast-to-noise ratio (CNR)

时间窗: Will be examined cross-sectionally on an as-recruited basis.

Indexes dopamine function

Glutamate/glycine magnetic resonance sptrectroscopy (MRS)

时间窗: Will be examined cross-sectionally on an as-recruited basis.

Indexes glutamate \& glycine concentration

次要结局

未报告次要终点

研究者

发起方
The Royal Ottawa Mental Health Centre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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