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临床试验/NCT05763966
NCT05763966招募中不适用

Uppsala Psychosis Cohort: a Multimodal Study in Early Stage Psychosis Patients, High Risk Individuals and Healthy Controls

Uppsala University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Measures of cognitive function, magnetic resonance imaging (MRI), electroencephalogram (EEG) in relation to SV2A in EPP, CHR-P and HC.

研究概览

简要总结

A multimodal longitudinal study in early stage psychosis patients and individuals at high risk for psychosis. Healthy controls are included for baseline comparisons. The aim is to investigate disease mechanisms of psychotic disorders, specifically focusing on the synaptic pruning hypothesis.

详细描述

This is a single-site observational study examining synaptic density using positron emission tomography (PET) and the radioligand [18F]SynVest-1 binding to the synaptic vesicle glycoprotein 2A. In addition to PET, the study includes clinical assessment, cognitive testing, multimodal magnetic resonance imaging (MRI) measures, neurophysiological measures, lumbar punction for cerebrospinal fluid (CSF) analyses, blood sampling, heart rate variability measures. Early stage psychosis patients and clinical high-risk individuals are subject to repeat assessment after 1 year (including PET), and at 3 and 5 years.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Measures of cognitive function, magnetic resonance imaging (MRI), electroencephalogram (EEG) in relation to SV2A in EPP, CHR-P and HC.

时间窗: 1 timepoint (baseline)

Analyses of group differences and correlational analyses between cognitive performance as measured using Measurement and Treatment Research to Improve Cognition in Schizophrenia battery (MATRICS), MRI measures of connectivity and metabolite levels, and EEG measures of cortical excitability to \[18F\]SynVesT-1 binding to SV2A will be performed in EPP, CHR-P and HC.

Changes in synaptic density in EPP and CHR-P between baseline and after 1 year.

时间窗: 1 year

Comparison of regional \[18F\]SynVesT-1 binding to SV2A between baseline and follow-up in EPP and CHR-P.

Candidate disease markers in cerebrospinal fluid in relation to changes in SV2A in EPP and CHR-P.

时间窗: 1 year

Analyses of group differences and correlational analyses between candidate disease markers in CSF to changes in \[18F\]SynVesT-1 binding to longitudinal differences in \[18F\]SynVesT-1 binding to SV2A will be performed in EPP and CHR-P.

Synaptic density in early stage psychosis (EPP) patients and individuals at Clinical High Risk for Psychosis (CHR-P) compared to healthy controls (HC).

时间窗: 1 timepoint (baseline)

Group comparisons of \[18F\]SynVesT-1 binding to the synaptic vesicle glycoprotein 2A (SV2A) at baseline between EPP, CHR-P and HC.

Measures of cognitive function, magnetic resonance imaging (MRI), electroencephalogram (EEG) in relation to changes in SV2A in EPP and CHR-P.

时间窗: 1 year

Analyses of group differences and correlational analyses between cognitive performance as measured using MATRICS, MRI measures of connectivity and metabolite levels, and EEG measures of cortical excitability to longitudinal differences in \[18F\]SynVesT-1 binding to SV2A will be performed in EPP and CHR-P.

Candidate disease markers in cerebrospinal fluid in relation to SV2A in EPP, CHR-P and HC.

时间窗: 1 timepoint (baseline)

Analyses of group differences and correlational analyses between candidate disease markers in CSF to \[18F\]SynVesT-1 binding to SV2A will be performed in EPP, CHR-P and HC.

次要结局

未报告次要终点

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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