NCT05316883 Biomarkers in Clozapine-responding Schizophrenia
| NCT ID | NCT05316883 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Jimmi Nielsen |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-02-28 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2021-02-28 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 responding patients. Patients will be offered treatment with clozapine according to national clinical guidelines. Before clozapine is initiated, patients will be offered a thoroughly neurobiological examination, and re-examination will be carried out after 12 weeks of treatment. The primary focus of the examinations will be immunological markers and autoantibodies in the blood and cerebrospinal fluid, permeability of the blood-brain barrier and magnetic resonance imaging of structural, neurochemical and functional brain changes.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Jimmi Nielsen, PhD
PRINCIPAL INVESTIGATOR
Mental health Service, Glostrup
Frequently Asked Questions
Who can join the NCT05316883 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05316883 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05316883 currently recruiting?
Yes, NCT05316883 is actively recruiting participants. Contact the research team at jimmi.nielsen@regionh.dk for enrollment information.
Where is the NCT05316883 trial being conducted?
This trial is being conducted at Glostrup Municipality, Denmark.
Who is sponsoring the NCT05316883 clinical trial?
NCT05316883 is sponsored by Jimmi Nielsen. The principal investigator is Jimmi Nielsen, PhD at Mental health Service, Glostrup. The trial plans to enroll 200 participants.
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