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| ID | Type | Description | Link |
|---|---|---|---|
| B300201318710 | Other Identifier | Belgian Study Registration Number |
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| Name | Class |
|---|---|
| Agentschap voor Innovatie door Wetenschap en Technologie | OTHER |
| Janssen Research & Development, LLC | INDUSTRY |
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Previous research has suggested central nervous system inflammatory activity to be critically involved in disease development and progression in schizophrenia, with a complex interplay of inflammatory mechanisms leading to the development of brain abnormalities and medical symptoms related to schizophrenia. However, the mutual interactions of different inflammatory pathways and their relation to disease course have not been sufficiently studied. This study therefore aims to explore the interaction of neuroinflammatory mechanisms in patients with schizophrenia and to assess whether the inflammatory activity in schizophrenia is state-dependent and occurs mainly during psychotic episodes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy controls | Healthy age- and sex-matched controls |
| |
| Schizophrenia patients | Young schizophrenia patients 18-40y |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]-PBR111 Positron Emission Tomography (PET) | Radiation | [18F]-PBR111 radioligand to assess binding to TSPO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Regional VT of [18F]PBR111 | Regional distribution volume in tissue (VT) of 2-(6-chloro-2-(4-(3-fluoropropoxy)phenyl)imidazo(1,2-a)pyridin-3-yl)-N,N-diethylacetamide (PBR111) labelled with fluorine-18 (18F) in schizophrenia patients and age- , gender-, and translocator protein (TSPO) binding profile- matched healthy controls | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral markers | Levels and ratios of inflammatory and neurotoxicity markers in blood samples of schizophrenia patients compared to healthy age- and gender-matched healthy controls. | 2 years |
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Inclusion Criteria:
Schizophrenia subjects:
total score of ≥14 on the positive scale of the "Positive and Negative Syndrome Scale" (PANSS) and at least a score of 5 on 1 item or a score of 4 on 2 "psychotic" PANSS items P2, P3, P5 or G9 at Screening.
Exclusion Criteria:
Healthy volunteers:
Schizophrenia patients:
- Calgary Depression Scale for Schizophrenia (CDSS) score >6 at screening
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Young schizophrenia patients admitted to psychiatric hospital for acute relapse or first-episode of psychosis
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Sabbe, MD PhD | Universiteit Antwerpen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatrisch Ziekenhuis Broeders Alexianen | Boechout | Antwerpen | 2530 | Belgium | ||
| Psychiatrisch Ziekenhuis St Norbertus |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D009422 | Nervous System Diseases |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Plasma samples
| Cognitive and psychomotor tasks | Behavioral | Cognitive and psychomotor tasks on digitizing tablet |
|
| Blood sampling | Biological | Blood sampling for peripheral inflammatory and neurotoxicity markers |
|
| Duffel |
| Antwerpen |
| 2570 |
| Belgium |
| Psychiatrisch Ziekenhuis Sint-Amedeus | Mortsel | Antwerp | 2640 | Belgium |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |