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Uppsala Psychosis Cohort

ConditionSchizophrenia; Psychosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-40
SponsorUppsala University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosis as assessed using DSM-5 of one of the following: schizophrenia, schizophreniform psychosis, psychosis not otherwise specified (NOS), brief psychosis, schizoaffective syndrome, delusional disorder

Onset of psychotic symptoms together with functional decline no more than 3 years prior to inclusion visit

Disqualifiers

Other dominant psychiatric illness that is deemed to be related to current psychotic symptoms (including bipolar disorder, major depressive disorder, autism)

Long-term daily treatment (<2 weeks) with benzodiazepines, such that there is an inability to refrain from treatment during testing procedures.

A history of diagnosis of a major psychiatric disorder, including substance use disorders.

A family history of psychotic disorders or bipolar disorder in first degree relatives.

Trial population

Early stage Psychosis Patients (EPP) (\<3 year duration) and individuals at clinical high risk for psychosis (CHR-P) are recruited from the psychiatry clinic. Healthy controls (HC) are recruited by advertisement.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    Observational study where participants are followed over time

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Early stage psychosis patients (EPP)1 intervention
Group B: Individuals at clinical high risk for psychosis (CHR-P)1 intervention
Group C: Healthy controls (HC)1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
1 timepoint (baseline)
2

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

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

Time frame
1 year
3

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

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.

Time frame
1 timepoint (baseline)
4

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

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.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uppsala University

Lead sponsor

Uppsala University Hospital

Collaborator

Source ClinicalTrials.gov
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