NCT05316883RecruitingPhase 4
Biomarkers in clozapine-responding schizophrenia
Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
biomarkers predicting clozapine response
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 10 Oct 2024
- Start date
- 10 Oct 2024
- Lead sponsor
- Region Hovedstaden
- Diseases
- Schizophrenia
- NCT number
- NCT05316883
- EU CT number
- 2024-515338-34-01
- EudraCT number
- 2019-003128-19
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Involuntarily psychiatric admittance during the study
- Any condition that interfere with compliance for obtaining bloodsamples weekly
- 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
Lab values
- Reduced bone marrow function according to blood samples (normal function defined as leucocytes > 3.3*109/l and neutrophil > 2.0*109/l)
Other
- Substance abuse that interfere with compliance
- Pregnancy (will be verified by urine-HCG-test in fertile females)
- Females who are breastfeeding
- Toxic or idiosyncratic agranulocytosis in the past
Who the study is looking for
- 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).
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Hovedstadens Psykiatriske Coordinator of this site? Confirm its status | Glostrup | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.