Uppsala Psychosis Cohort

NCT05763966 | Recruiting

• 1 other identifier: UPC_v 1.0
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Psychosis

Outcome Measures

Primary Outcomes (6)

• 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.

  1 timepoint (baseline)

• 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.

  1 year

• 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.

  1 timepoint (baseline)

• 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.

  1 year

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

  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.

  1 timepoint (baseline)

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

  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.

  1 year

Study Arms (3)

Early stage psychosis patients (EPP)

Diagnosis of psychotic disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) with onset of less than 3 years prior to inclusion.

Other: No intervention

Individuals at clinical high risk for psychosis (CHR-P)

Fulfills criteria for clinical high risk for psychosis according to Structured Interview for Psychosis-risk Syndromes (SIPS).

Other: No intervention

Healthy controls (HC)

Age- and sexmatched controls.

Other: No intervention

Interventions

No intervention OTHER

Observational study where participants are followed over time

Early stage psychosis patients (EPP); Healthy controls (HC); Individuals at clinical high risk for psychosis (CHR-P)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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
• For CHR-P:
• Clinical high risk for psychosis as determined using Structured Interview for Psychosis-risk Syndromes (SIPS).

You may not qualify if:

• 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.
• Treatment with any antihemostatic medication within 2 weeks of lumbar puncture and arterial line placement of either the baseline or 1 year follow-up.
• 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.

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, CSF

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Simon Cervenka, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Cervenka, MD, PhD

CONTACT

+46709944226; simon.cervenka@neuro.uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

SE (1)