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Neuromelanin-sensitive magnetic resonance imaging in young adults at clinical high-risk for psychosis

Neuromelanin-sensitive magnetic resonance imaging in young adults at clinical high-risk for psychosis - Neuromelanin in young adults with unusual experiences

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57584
Enrollment
120
Registered
2025-05-02
Start date
2025-12-05
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Clinical high-risk of psychosis (CHR-P)

Interventions

None listed

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
16 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Age 16-30 years old. 2. Dutch-speaking. 3. CHR-P only: Meets CHR-P classification criteria (i.e., the presence of attenuated psychotic symptoms and a reduction in social functioning). Of note, a CHR-P classification can also be made if a participant has a first-degree relative with a psychotic disorder, but we will only include CHR-P individuals if they themselves have experienced (attenuated) psychotic symptoms.

Exclusion criteria

Exclusion criteria: All participants: 1. Current or past (suspected) presence of a psychotic disorder, such as schizophrenia or other psychotic disorder, bipolar disorder, depressive disorder with psychotic features. 2. Current or past (suspected) presence of a neurological disorder (e.g., Parkinson*s disease, epilepsy), evidence of brain damage, and/or other medical illness (e.g., diabetes mellitus) that may affect brain function. 3. Intellectual disability (IQ

Design outcomes

Secondary

MeasureTime frame
Supplementary NM-MRI data from FEP patients and HCs: ANOVA will be used to examine the difference in NM-MRI CNR in the SN between CHR-P individuals, FEP, and HCs. For this analysis, FEP and additional HC data will be obtained from previous NM-MRI studies conducted at the Amsterdam UMC. In these supplementary analyses, we will also explore the relationship between NM-MRI signal and age, sex, drug/medication use, and psychosis symptom severity, if sufficient information on these variables is available. Finally, exploratory voxel-wise analysis of NM-MRI data will be conducted in addition to the main region of interest analysis.

Primary

MeasureTime frame
(1) Nigrostriatal dopaminergic functioning, as assessed with the NM-MRI contrast-to-noise ratio (CNR) in the substantia nigra (SN). These outcomes will be compared between CHR-P and HCs. (2) The relationship between baseline NM-MRI CNR and three-year conversion to a psychotic disorder in CHR-P individuals. The development of a (diagnosed) psychotic disorder will be evaluated through a follow-up clinical evaluation of the participant (in-person or by telephone; this is the preferred method) or by consulting their treating mental healthcare professional or general practitioner and/or through data linkage with health records provided by Statistics Netherlands.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)