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Clinical Trials/NCT05763966
NCT05763966
Recruiting
Not Applicable

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

Uppsala University1 site in 1 country120 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia; Psychosis
Sponsor
Uppsala University
Enrollment
120
Locations
1
Primary Endpoint
Measures of cognitive function, magnetic resonance imaging (MRI), electroencephalogram (EEG) in relation to SV2A in EPP, CHR-P and HC.
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
December 31, 2031
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 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.

Time Frame: 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.

Time Frame: 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).

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Study Sites (1)

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