NCT05316883

Biomarkers in Clozapine-responding Schizophrenia

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Jimmi Nielsen · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Schizophrenia
• Psychosis

Interventions

Type	Name	Description
DRUG	Clozapine	clinical doses adjusted to sideeffects and clinical effect

Timeline

• Start date: 2021-02-28
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2022-04-07
• Last updated: 2026-01-20

Locations

1 site across 1 country: Denmark