Uppsala Psychosis Cohort

Recruiting

• Conditions: Schizophrenia; Psychosis
• Interventions: Other: No intervention

• Registration Number: NCT05763966
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-10
• Study Start: 2023-04-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-20
• Primary Completion: 2026-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals at clinical high risk for psychosis (CHR-P)	No intervention	Fulfills criteria for clinical high risk for psychosis according to Structured Interview for Psychosis-risk Syndromes (SIPS).
Early stage psychosis patients (EPP)	No intervention	Diagnosis of psychotic disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) with onset of less than 2 years prior to inclusion.
Healthy controls (HC)	No intervention	Age- and sexmatched controls.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden