Biomarkers in patients with Schizophrenia responding to Clozapine treatment
- Conditions
- schizophreniaMedDRA version: 21.1 Level: LLT Classification code 10009134 Term: Chronic schizophrenia System Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2019-003128-19-DK
- Lead Sponsor
- Psykiatrisk Center Glostrup
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 200
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method