Status:
UNKNOWN
Biomarkers in Clozapine-responding Schizophrenia
Lead Sponsor:
Mental Health Services in the Capital Region, Denmark
Conditions:
Schizophrenia
Psychosis
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
Patients will be examined before and after 12 weeks of treatment with clozapine Examinations at baseline and follow up will be: * Clinical ratings * Blood inflammatory markers * Inflammatory markers...
Eligibility Criteria
Inclusion
- 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
- 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 chlorpromazine 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).
Exclusion
- 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
- Reduced bone marrow function according to blood samples
- According to information from patient and available files, noUncontrolled
- Current uncontrolled epilepsy
- Current circulatory collapse and / or CNS depression for any cause
- Current severe kidney, heart or liver disease
- Current paralytic ileus
Key Trial Info
Start Date :
February 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05316883
Start Date
February 28 2021
End Date
December 31 2024
Last Update
April 7 2022
Active Locations (1)
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1
Mental Health Services Glostrup, Unit for Complicated Schizophrenia
Glostrup Municipality, Denmark, 2600