Schizophrenia; PsychosisUPCNCT05763966
Uppsala Psychosis Cohort
An observational study of Schizophrenia; Psychosis, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia; Psychosis
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2023to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala
Simon Cervenka, MD PhD
About this study
Official title: Uppsala Psychosis Cohort: a Multimodal Study in Early Stage Psychosis Patients, High Risk Individuals and Healthy Controls
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.
Read the 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
- Being tested
- No intervention
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study where participants are followed over time
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: No intervention | |
| Healthy controls (HC) | Age- and sexmatched controls. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia; PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Sponsor
- Investigators
- Simon Cervenka, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763966
- Sponsor's protocol ID
- UPC_v 1.0
- Acronym
- UPC
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2023
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available to other researchers upon request, as allowed by national legislation.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uppsala Psychosis Cohort: a Multimodal Study in Early Stage Psychosis Patients, High Risk Individuals and Healthy Controls
- ClinicalTrials.gov ID
- NCT05763966
- Acronym / sponsor ID
- UPC / UPC_v 1.0
- Conditions
- Schizophrenia; Psychosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early stage psychosis patients (EPP) | – | Other: No interventionDiagnosis 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. |
| Individuals at clinical high risk for psychosis (CHR-P) | – | Other: No interventionFulfills criteria for clinical high risk for psychosis according to Structured Interview for Psychosis-risk Syndromes (SIPS). |
| Healthy controls (HC) | – | Other: No interventionAge- and sexmatched controls. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
- Clinical high risk for psychosis as determined using Structured Interview for Psychosis-risk Syndromes (SIPS).
Key exclusion criteria (17 listed)
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservational study where participants are followed over time | Other | Early stage psychosis patients (EPP), Healthy controls (HC), Individuals at clinical high risk for psychosis (CHR-P) |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Undecided. Data will be made available to other researchers upon request, as allowed by national legislation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simon Cervenka, MD, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia; Psychosis, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Cervenka, MD, PhD (+46709944226, simon.cervenka@neuro.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.