Studying Biomarkers in Schizophrenia Patients Who Respond to Clozapine
Tests clozapine in adults with treatment-resistant schizophrenia, studying biological markers before and after.
Plain-language title generated from the registry record
Registry title: Biomarkers in Clozapine-responding Schizophrenia
Key facts
- Where
- Glostrup, DenmarkSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT05316883, who can take part
Where in Denmark
- Region Hovedstadens PsykiatriskeGlostrup, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jimmi Nielsen
- Trial code
- NCT05316883EU 2024-515338-34-01
- Record updated
- 20 January 2026
- Original description
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.Read full original descriptionShow less
Biomarkers in Clozapine-responding Schizophrenia
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.
Inclusion: According to ICD-10 fulfill diagnostic criteria for schizophrenia (F20.x), chronical paranoid psychoses (F22), Schizoaffective psychoses (F25) or other non-organic psychoses (F28/F29); Age 18-65 years; Legally competent; Stabil antipsychotic treatment during last month; Being treatment refractory according to TRIPP-guidelines (Howes et al. 2017) defined as having tried at least two antipsychotic drugs in sufficient dosage (≥600 mg chlorpromazine equivalent) for a sufficient time (≥ 6 weeks) without sufficient symptom improvement (still a moderate level of positive symptoms); Recreational use of substances is allowed as long as it does not interfere with compliance; Fertile females must use safe contraception (spiral or any hormonal contraception).
Exclusion: Involuntarily psychiatric admittance during the study; According to information from patient and available files, noUncontrolled; Current uncontrolled epilepsy; Current circulatory collapse and / or CNS depression for any cause; Current severe kidney, heart or liver disease; Current paralytic ileus; Substance abuse that interfere with compliance; Pregnancy (will be verified by urine-HCG-test in fertile females); Toxic or idiosyncratic agranulocytosis in the past; Reduced bone marrow function according to blood samples.