CLOZAPINE for Schizophrenia

Inclusion criteria

• {"criterion_text":"- According to ICD-10 fulfill diagnostic criteria of schizophrenia (F20.x), chronical paranoid psychoses (F22), Schizoaffective psychoses (F25) or other non-organic psychoses (F28/29)\n- Age 18-64 years\n- Legally competent\n- Stable antipsychotic treatment during the last month\n- 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).\n- Recreational use of substances is allowed as long as it does not interfere with compliance\n- Fertile females must use safe contraception (spiral or any hormonal contraception)."}

Exclusion criteria

• {"criterion_text":"- Involuntarily psychiatric admittance during the study\n- Substance abuse that interfere with compliance\n- Any condition that interfere with compliance for obtaining bloodsamples weekly\n- Pregnancy (will be verified by urine-HCG-test in fertile females)\n- Females who are breastfeeding\n- Toxic or idiosyncratic agranulocytosis in the past\n- Reduced bone marrow function according to blood samples (normal function defined as leucocytes > 3.3*109/l and neutrophil > 2.0*109/l)\n- According to information from patient and available files, no o\tCurrent uncontrolled epilepsy o\tCurrent circulatory collapse and / or CNS depression for any cause o\tCurrent severe kidney, heart or liver disease o\tCurrent paralytic ileus"}

Primary endpoints

• {"endpoint_text":"- Permeability of the blood-brain barrier blood and CSF inflammatory cytokines","definition_or_measurement_approach":""}

Denmark

Earliest CTIS Part Ii Submission Date

17-10-2024

Latest Decision Or Authorization Date

23-10-2024

Processing Time Days

6

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

Region Hovedstaden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}