A Phase 4 interventional study of Clozapine in Schizophrenia and Psychosis, sponsored by Jimmi Nielsen. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Jimmi Nielsen · Phase 4, Interventional, and Basic science
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:
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's planned enrollment of 200 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Jimmi Nielsen is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
According to information from patient and available files, noUncontrolled
Open label clozapine will be given to all participants in clinical doses adjusted to sideeffects and clinical effect
Drug: Clozapine
clinical doses adjusted to sideeffects and clinical effect
Qalb
Quotient albumin (Qabl) in cerebrospinal fluid (CSF) compared to plasma
Time frame: Baseline
Change in Qalb
Change in quotient albumin in cerebrospinal fluid compared to plasma
Time frame: Baseline and after 12 weeks
Change in IL-6 and TGF-beta
Change in interleukin 6 (IL-6) and transcription growth factor beta (TGF-beta)
Time frame: Baseline and after 12 weeks
Change in FA, MD, AD and RD
Change in fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (AD) and radial diffusivity (RD)
Time frame: Baseline and after 12 weeks
Change in cortical thickness as measured with FreeSurfer
Change in cortical thickness as measured with FreeSurfer
Time frame: Baseline and after 12 weeks
Change in glutamate in ACC and thalamus measured with MTI
Change in glutamate in anterior cingulate cortex (ACC) and thalamus measured with magnetic transfer imaging (MTI)
Time frame: Baseline and after 12 weeks
Plan to share: No
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Jimmi Nielsen