BridgeMD
Biomarkers in clozapine-responding schizophrenia
EU CTIS ID: 2024-515338-34-01
What this study is testing
biomarkers predicting clozapine response
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
- Age 18-64 years
- Legally competent
- Stable antipsychotic treatment during the 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
You likely can't join if
- 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)
- Females who are breastfeeding
- Toxic or idiosyncratic agranulocytosis in the past
See the full eligibility criteria
- 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)
- Age 18-64 years
- Legally competent
- Stable antipsychotic treatment during the 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).
- 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)
- Females who are breastfeeding
- Toxic or idiosyncratic agranulocytosis in the past
- Reduced bone marrow function according to blood samples (normal function defined as leucocytes > 3.3*109/l and neutrophil > 2.0*109/l)
- According to information from patient and available files, no o Current uncontrolled epilepsy o Current circulatory collapse and / or CNS depression for any cause o Current severe kidney, heart or liver disease o Current paralytic ileus
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.