Clinical Trials in Sweden / NCT05763966
Recruiting
Observational
Uppsala Psychosis Cohort
NCT05763966 · tracked via the Priya Life Science Sweden tracker
Condition(s) studied
Schizophrenia; Psychosis
Investigational drug(s) / intervention(s)
No intervention
No intervention: Observational study where participants are followed over time
Study 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.
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 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.
Primary outcome measure(s)
- Synaptic density in early stage psychosis (EPP) patients and individuals at Clinical High Risk for Psychosis (CHR-P) compared to healthy controls (HC). — 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. - Changes in synaptic density in EPP and CHR-P between baseline and after 1 year. — 1 year
Comparison of regional \[18F\]SynVesT-1 binding to SV2A between baseline and follow-up in EPP and CHR-P. - Measures of cognitive function, magnetic resonance imaging (MRI), electroencephalogram (EEG) in relation to SV2A in EPP, CHR-P and HC. — 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. - Measures of cognitive function, magnetic resonance imaging (MRI), electroencephalogram (EEG) in relation to changes in SV2A in EPP and CHR-P. — 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. - Candidate disease markers in cerebrospinal fluid in relation to SV2A in EPP, CHR-P and HC. — 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. - Candidate disease markers in cerebrospinal fluid in relation to changes in SV2A in EPP and CHR-P. — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Uppsala University Hospital | Uppsala | Sweden | Recruiting |
More Uppsala University trials in Sweden
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05763966 on ClinicalTrials.gov ↗ ← All trials in Sweden