Actively Recruiting
Biomarkers in Clozapine-responding Schizophrenia
Led by Jimmi Nielsen · Updated on 2026-01-20
200
Participants Needed
1
Research Sites
461 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Biomarkers in Clozapine-responding Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of schizophrenia, chronic paranoid psychoses, schizoaffective psychoses, or other non-organic psychoses according to ICD-10
- Age between 18 and 65 years
- Legally competent to consent
- Stable antipsychotic treatment for at least one month
- Treatment refractory according to TRIPP guidelines: tried at least two antipsychotic drugs at sufficient dose (≥600 mg chlorpromazine equivalent) for at least 6 weeks without sufficient symptom improvement
- Recreational substance use allowed if it does not affect treatment compliance
- Fertile females must use safe contraception (spiral or hormonal methods)
You will not qualify if you...
- Involuntary psychiatric admission during the study
- Substance abuse that interferes with treatment compliance
- Pregnancy (verified by urine-HCG test in fertile females)
- History of toxic or idiosyncratic agranulocytosis
- Reduced bone marrow function based on blood tests
- Current uncontrolled epilepsy
- Current circulatory collapse or central nervous system depression
- Current severe kidney, heart, or liver disease
- Current paralytic ileus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mental Health Services Glostrup, Unit for Complicated Schizophrenia
Glostrup Municipality, Denmark, Denmark, 2600
Actively Recruiting
Research Team
J
Jimmi Nielsen, PhD
CONTACT
M
Mette Nielsen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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