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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Clozapine
Drugclinical doses adjusted to sideeffects and clinical effect
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: clozapine treatmentOther 1 intervention
Trial outcomes
Primary outcomes
1
Qalb
Quotient albumin (Qabl) in cerebrospinal fluid (CSF) compared to plasma
Time frame
Baseline2
Change in Qalb
Change in quotient albumin in cerebrospinal fluid compared to plasma
Time frame
Baseline and after 12 weeks3
Change in IL-6 and TGF-beta
Change in interleukin 6 (IL-6) and transcription growth factor beta (TGF-beta)
Time frame
Baseline and after 12 weeksSecondary outcomes
1
Change in FA, MD, AD and RD
Change in fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (AD) and radial diffusivity (RD)
Time frame
Baseline and after 12 weeks2
Change in cortical thickness as measured with FreeSurfer
Change in cortical thickness as measured with FreeSurfer
Time frame
Baseline and after 12 weeks3
Change in glutamate in ACC and thalamus measured with MTI
Change in glutamate in anterior cingulate cortex (ACC) and thalamus measured with magnetic transfer imaging (MTI)
Time frame
Baseline and after 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jimmi Nielsen
Lead sponsor
Copenhagen University Hospital, Hvidovre
Sponsor institution
Source ClinicalTrials.gov