Actively Recruiting
Biomarkers in Clozapine-responding Schizophrenia
Led by Jimmi Nielsen · Updated on 2026-01-20
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to identify clinical and biological markers in patients with treatment-resistant schizophrenia who are eligible for clozapine treatment. The study focuses on patients with schizophrenia or related psychoses who have not responded adequately to at least two antipsychotic drugs. The goal is to understand which patients respond to clozapine by examining immunological markers, autoantibodies, and brain changes. Participants will receive open-label clozapine treatment, with doses adjusted based on side effects and clinical response. Before starting treatment, patients will undergo detailed neurobiological exams, including blood and cerebrospinal fluid tests and magnetic resonance imaging (MRI). After 12 weeks of treatment, these examinations will be repeated to assess changes. During the study, participants will have clinical ratings, blood tests for inflammatory markers, cerebrospinal fluid analysis, MRI scans focusing on brain structure and chemistry, and selected cognitive tests. Researchers will measure changes in specific immune markers and brain imaging features from baseline to 12 weeks. The total study period includes baseline assessments, 12 weeks of treatment, and follow-up evaluations to monitor treatment effects and safety.
CONDITIONS
Brief 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
- Stable antipsychotic treatment for the last month
- Treatment refractory as defined by having tried at least two antipsychotic drugs in sufficient dosage (≥600 mg chlorpromazine equivalent) for at least 6 weeks without sufficient symptom improvement
- Recreational substance use allowed if it does not affect compliance
- Fertile females must use safe contraception (spiral or hormonal)
You will not qualify if you...
- Involuntary psychiatric admittance during the study
- Substance abuse interfering with 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive open label clozapine at clinical doses adjusted to side effects and clinical effect.
1 baseline visit and 1 follow-up visit
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
M
Mette Nielsen, PhD
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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