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Report for Clinical Trial NCT02009826

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase 0 Clinical Protocol: A Longitudinal and Multimodal Exploratory Study to Evaluate a Neuroinflammatory Hypothesis in Patients With Schizophrenia Compared to Young Healthy Subjects

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.

NCT02009826 Schizophrenia Psychosis
MeSH:Schizophrenia Psychotic Disorders Mental Disorders
HPO:Psychosis Schizophrenia

3 Interventions

Name: [18F]-PBR111 Positron Emission Tomography (PET)

Description: [18F]-PBR111 radioligand to assess binding to TSPO
Type: Radiation
Group Labels: 2

Healthy controls Schizophrenia patients

Name: Cognitive and psychomotor tasks

Description: Cognitive and psychomotor tasks on digitizing tablet
Type: Behavioral
Group Labels: 2

Healthy controls Schizophrenia patients

Name: Blood sampling

Description: Blood sampling for peripheral inflammatory and neurotoxicity markers
Type: Biological
Group Labels: 2

Healthy controls Schizophrenia patients

Primary Outcomes

Description: 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

Measure: Regional VT of [18F]PBR111

Time: 2 years

Secondary Outcomes

Description: Levels and ratios of inflammatory and neurotoxicity markers in blood samples of schizophrenia patients compared to healthy age- and gender-matched healthy controls.

Measure: Peripheral markers

Time: 2 years

Time Perspective: Prospective


There is one SNP


1 rs6971

- Low affinity binder of the TSPO, as determined by rs6971 polymorphism genotyping at Screening - Use of benzodiazepines for 3x the half-life prior to PET-scan - Presence of irremovable magnetic materials in or on the body - Has a medical history of organic brain disease - Has a medical history of traumatic brain injury - Has a medical history of allergic reaction to any of the substances in the tracer fluid.

HPO Nodes