Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in brain structural modifications in terms of cortical superficial area measured using magnetic resonance imaging
研究概览
简要总结
The present longitudinal study aims to investigate the impact of lurasidone treatment in recent-onset psychosis patients. The effects of lurasidone will be studied primarily in terms of structural and myelin modifications, in relation to clinical outcomes, before and after treatment and in healthy controls. Furthermore, neuropsychological tests will be used to evaluate changes in cognitive performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（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
Recent-onset schizophrenia
Patients diagnosed with schizophrenia with onset in the last 5 years that will be started on lurasidone or that have been on treatment with lurasidone for less than two weeks at the time of enrollment.
干预措施: Lurasidone (Drug)
结局指标
主要结局
Changes in brain structural modifications in terms of cortical superficial area measured using magnetic resonance imaging
时间窗: Before and at three months of treatment
Modifications of cortical superficial area measuring using magnetic resonance imaging
Changes in brain structural modifications in terms of cerebral cortex thickness measuring using magnetic resonance imaging
时间窗: Before and at three months of treatment
Modifications of cerebral cortex thickness measuring using magnetic resonance imaging
Changes in myelin integrity measured using magnetic resonance imaging
时间窗: Before and at three months of treatment
Modifications of myelinization status measured in terms of myelin water fraction using magnetic resonance imaging
Changes in brain structural modifications in terms of grey matter volume measured using magnetic resonance imaging
时间窗: Before and at three months of treatment
Modifications of grey matter volume measuring using magnetic resonance imaging
次要结局
- Evaluation of efficacy as assessed by Brief Psychiatric Rating Scale (BPRS)(once per month during three months of treatment)
- Structural differences in patients at baseline vs healthy controls measured using magnetic resonance imaging(baseline)
- Evaluation of efficacy as assessed by Positive and Negative Syndrome Scale (PANSS)(once per month during three months of treatment)
- Changes in cognitive performance as assessed by Brief Assessment of Cognition in Schizophrenia (BAC-S)(once per month during three months of treatment)
- Number of Adverse effects(three months of treatment)
- Myelinization differences in patients at baseline vs healthy controls measured using magnetic resonance imaging(baseline)