Uppsala Psychosis Cohort

Schizophrenia; Psychosis Clinical Trial

— UPC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05763966
• Other study ID #: UPC_v 1.0
• Status: Not yet recruiting
• Start date: March 15, 2023
• Est. completion date: December 31, 2031

Study information

• Verified date: February 2023
• Source: Uppsala University
• Contact: Simon Cervenka, MD, PhD
• Phone: +46709944226
• Email: simon.cervenka[@]neuro.uu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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 2 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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia; Psychosis

Intervention

Other:
• No intervention
Observational study where participants are followed over time

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Uppsala University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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