Uppsala Psychosis Cohort

NCT ID: NCT05763966

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2031-12-31

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.

Conditions

Schizophrenia; Psychosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No intervention

Intervention Type: OTHER

Observational study where participants are followed over time

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).

No intervention

Intervention Type: OTHER

Observational study where participants are followed over time

Healthy controls (HC)

Age- and sexmatched controls.

No intervention

Intervention Type: OTHER

Observational study where participants are followed over time

Interventions

No intervention

Observational study where participants are followed over time

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uppsala University Hospital

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Cervenka, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Uppsala University Hospital

Uppsala, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Simon Cervenka, MD, PhD

Role: CONTACT

simon.cervenka@neuro.uu.se

+46709944226

Facility Contacts

Simon Cervenka, MD PhD

Role: primary

Other Identifiers

UPC_v 1.0

Identifier Type: -

Identifier Source: org_study_id