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NCT Number: NCT05763966

Uppsala Psychosis Cohort

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.

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Key information

Conditions

Schizophrenia; Psychosis Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University Hospital

Uppsala, Sweden

Location status: Recruiting

Location contact

Simon Cervenka, MD PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For EPP:

  • 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

For CHR-P:

Clinical high risk for psychosis as determined using Structured Interview for Psychosis-risk Syndromes (SIPS).

Exclusion criteria

For EPP and CHR-P:

  • 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.

For HC:

  • 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.

For all participants:

  • Evidence based on medical history, clinical signs, MRI or laboratory tests of clinically significant somatic disorder, or previous disorder with brain engagement (e.g. tumour, neuroinflammatory disease, epilepsy) or significant brain trauma.
  • Exposure to an effective radiation dose of 25 mSv during the past year.
  • Pregnancy, lactating or breastfeeding (women).
  • Lack of proficiency in Swedish language, or documented intellectual disability that prohibits ability to give informed consent.
  • Meets diagnostic criteria of substance use disorder (excluding nicotine dependence) as assessed using DSM-5 or as determined using repeated positive urine screens during the course of the study.
  • Metallic object in the eye, or ferro/electromagnetic implants. History of claustrophobic anxiety during MRI.
  • Symptoms of severe bacterial, fungal, or viral infection (including upper respiratory tract infection), with systemic effects as detected by e.g. fever, within 7 days prior to inclusion.
  • Treatment with any antihemostatic medication within 2 weeks of lumbar puncture and arterial line placement of either the baseline or 1 year follow-up.
  • Blood donation (1 unit or more) within 90 days prior to Screening, plasma donation from 1 week prior to Screening, and platelet donation from 6 weeks prior to inclusion.
  • Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participant unsuitable for enrollment. This may include very high symptom severity or signs of aggressiveness and hostility.

Treatment and study plan

No intervention

Other

Observational study where participants are followed over time

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).

    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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Simon Cervenka, MD, PhD

CONTACT

[email protected]

+46709944226

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Uppsala University Hospital

Registry information

Official study title

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

Acronym: UPC

Important dates

Study start
2023
Primary completion
2026
Study completion
2031
First posted
Mar 10, 2023
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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