About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Involuntarily psychiatric admittance during the study
Substance abuse that interfere with compliance
Pregnancy (will be verified by urine-HCG-test in fertile females)
Toxic or idiosyncratic agranulocytosis in the past
Trial design
Treatments tested in this trial
- Clozapine
Treatment groups
Sponsors and collaborators
Jimmi Nielsen
Lead sponsor
Copenhagen University Hospital, Hvidovre
Sponsor institution