RecruitingPhase 4NCT05316883

Biomarkers in Clozapine-responding Schizophrenia


Sponsor

Jimmi Nielsen

Enrollment

200 participants

Start Date

Feb 28, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study looks for biological markers (called biomarkers) in the blood and brain of people with schizophrenia who respond well to clozapine — a powerful antipsychotic drug used when other medications haven't worked. Finding these markers could help predict who will benefit from clozapine and lead to better treatments. **You may be eligible if...** - You are between 18 and 65 years old and legally competent - You have been diagnosed with schizophrenia, chronic paranoid psychosis, schizoaffective disorder, or another non-organic psychosis (per ICD-10 criteria) - Your antipsychotic treatment has been stable for the past month - You are considered treatment-resistant (meaning at least 2 prior antipsychotic drugs at adequate doses and durations did not help enough) **You may NOT be eligible if...** - You have not tried at least 2 prior antipsychotic treatments without adequate response - You are not legally competent to consent - Your condition is unstable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGClozapine

clinical doses adjusted to sideeffects and clinical effect


Locations(1)

Mental Health Services Glostrup, Unit for Complicated Schizophrenia

Glostrup Municipality, Denmark, Denmark

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NCT05316883


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