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An observational study using the radioligand [11C]-UCB-J for imaging synaptic density in healthy participants, patients with a psychotic disorder and their healthy siblings

An observational study using the radioligand [11C]-UCB-J for imaging synaptic density in healthy participants, patients with a psychotic disorder and their healthy siblings - Synaptic density in psychotic disorders

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49941
Enrollment
Unknown
Registered
2019-07-31
Start date
2020-07-08
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cognition (thinking) Schizophrenia schizophrenia, cognition (thinking)

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. The participant understands the study and provides written informed consent 2. Must be between the age of 26-65 3. For patients: must have a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder 4. For siblings: must have 1 brother or sister with a disorder specified under point 3. The sibling is not necessarily related to one of the participants from the patient group. 5. For controls: subjects must be free of any psychiatric or neurological disease and should not have any first- or second-degree relatives with one of the disorders specified under point 3. 6. Dutch as native language

Exclusion criteria

Exclusion criteria: 1. Participation in a scientific research study during the past year involving radiation (or any other form of exposure to the same amount of radiation within the past year via, e.g., 25 or more transatlantic flights during the past year) 2. MRI incompatible implants in the body 3. The possibility of having metal particles in the eyes 4. Tattoo*s containing red pigments that form a safety risk 5. Dangerous or harmful behaviour (i.e. behaviour with a risk of severe physical injury, or actual physical injury inflicted, to self or others) occurred in the last 3 months 6. Pregnancy 7. Treatment with levetiracetam or brivaracetam (contraindication for [11C]-UCB-J) 8. Speech disorders (e.g., stuttering) 9. Uncorrected hearing disorder

Design outcomes

Primary

MeasureTime frame
MRI parameters: • Functional connectivity defined in terms of GRAPH theory, i.e., number of nodes and edges, minimal pathlengths and effectivity of the network • Grey matter volumes as measured by MRI. MRI scans will be acquired on a standard 3 Tesla Siemens clinical scanner located at the Radiology Department of the University Medical Center Groningen. • Metabolites concentrations as assessed with MRS. PET parameters: PET parameters are defined in a PET analysis plan and include: • Specific/non-specific [11C]-UCB-J binding (expressed by volumes of distribution) • Time-activity courses • The volume of distribution per region per subject • Distribution volume ratios Cognitive and clinical parameters: • PANSS: Positive and Negative Syndrome Scale • BACS: Brief assessment of cognition in schizophrenia • Symbol Search: a measure of information processing speed derived from the WAIS-IV • Stroop task • CASH-interview: Comprehensive Assessment of Symptoms and History - the PRAAT language assesment interview

Countries

Netherlands

Contacts

Public ContactM. Germann

Universitair Medisch Centrum Groningen

m.germann@umcg.nl0503616323

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)