schizophrenia MedDRA version: 21.1 Level: LLT Classification code 10009134 Term: Chronic schizophrenia System Organ Class: 100000004873
Conditions
Interventions
Product Name: clozapine
Pharmaceutical Form: Tablet
INN or Proposed INN: clozapine
CAS Number: 5786-21-0
Other descriptive name: CLOZAPINE
Concentration unit: mg milligram(s)
Concentration type: range
Sponsors
Psykiatrisk Center Glostrup
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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 18-64 years; •Legally competent; •Stable antipsychotic treatment during last month •Being treatment refractory according to TRIPP-guidelines (Howes et al. 2017) defined as having tried at least two antipsychotic drugs in sufficient dosage (=600 mg clorpromazine equivalent) for a sufficient time (= 6 weeks) without sufficient symptom improvement (still a moderate level of positive symptoms). •Recreational use of substances is allowed as long as it does not interfere with compliance •Fertile females must use safe contraception (spiral or any hormonal contraception). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Involuntarily psychiatric admittance during the study •Substance abuse that interfere with compliance •Any condition that interfere with compliance for obtaining bloodsamples weekly •Pregnancy (will be verified by urine-HCG-test in fertile females) •Toxic or idiosyncratic agranulocytosis in the past •Reduced bone marrow function according to blood samples •According to information from patient and available files, no -current uncontrolled epilepsy -current circulatory collapse and/or CNS depression for any cause -current severe kidney, heart or liver disease -current paralytic ileus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 the permeability of the blood-brain barrier.;Secondary Objective: The secondary objective of the study is immunological markers and autoantibodies in the blood and magnetic resonance imaging of structural, neurochemical and functional brain changes.;Primary end point(s): Permeability of the blood-brain-barrier blood and csf inflamatory cytokines ;Timepoint(s) of evaluation of this end point: At baseline and after 12 weeks of clozapine treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in brain white matter Changes in cortical thickness glutamate in ACC and thalamus;Timepoint(s) of evaluation of this end point: baseline and after 12 weeks of clozapine treatment | — |
Countries
Denmark
Contacts
Public ContactCenter for Kompliceret Skizofreni
Mental Health services, Capital region of Denmark
Outcome results
None listed