Biomarkers in Clozapine-responding Schizophrenia

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-64
SponsorJimmi Nielsen

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

200 Participants
are divided into 1 treatment group

Sponsors and collaborators

Jimmi Nielsen

Lead sponsor

Copenhagen University Hospital, Hvidovre

Sponsor institution