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NCT05316883 · ClinicalTrials.gov record · last posted 2026-01-20

Biomarkers in Clozapine-responding Schizophrenia

Study acronym: BiCS
StatusRecruiting
PhasePhase 4
Started2021-02-28
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from the ClinicalTrials.gov record
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.

Amendment record 1 amendment on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended once since 2022-04-06. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

Trial Details
NCT Number NCT05316883
Lead Sponsor Jimmi Nielsen
Conditions Schizophrenia, Psychosis
Enrollment 200 participants
Start Date 2021-02-28
Primary Completion 2029-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-20