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The outline of the current project is to establish a cohort of patients with treatment refractory schizophrenia eligible for clozapine, to identify clinical and biological characteristics of clozapine responding patients. Patients will be offered treatment with clozapine according to national clinical guidelines. Before clozapine is initiated, patients will be offered a thoroughly neurobiological examination, and re-examination will be carried out after 12 weeks of treatment. The primary focus of the examinations will be immunological markers and autoantibodies in the blood and cerebrospinal fluid, permeability of the blood-brain barrier and magnetic resonance imaging of structural, neurochemical and functional brain changes.
Patients will be examined before and after 12 weeks of treatment with clozapine Examinations at baseline and follow up will be: * Clinical ratings * Blood inflammatory markers * Inflammatory markers in cerebro spinal fluid * MRI : examination of grey \& white matter, glutamate and GABA in Anterior Cingulate cortex and glutamate in thalamus, * selected cognitive measures
Age
18 - 64 years
Sex
ALL
Healthy Volunteers
No
Mental Health Services Glostrup, Unit for Complicated Schizophrenia
Glostrup Municipality, Denmark, Denmark
Start Date
February 28, 2021
Primary Completion Date
December 31, 2029
Completion Date
December 31, 2029
Last Updated
January 20, 2026
200
ESTIMATED participants
Clozapine
DRUG
Lead Sponsor
Jimmi Nielsen
NCT07226895
NCT06159673
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07455929