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Recruiting NCT05316883

Biomarkers in Clozapine-responding Schizophrenia

Phase IV Interventional Schizophrenia Psychosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clozapine.
Who it may be relevant to
Registry conditions: Schizophrenia, Psychosis. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

Patients will be examined before and after 12 weeks of treatment with clozapine

Examinations at baseline and follow up will be:

* Clinical ratings * Blood inflammatory markers * Inflammatory markers in cerebro spinal fluid * MRI : examination of grey \& white matter, glutamate and GABA in Anterior Cingulate cortex and glutamate in thalamus, * selected cognitive measures

Interventions

  • Drug Clozapine
    clinical doses adjusted to sideeffects and clinical effect

Primary outcome measures

  • Qalb [Time frame: Baseline]
  • Change in Qalb [Time frame: Baseline and after 12 weeks]
  • Change in IL-6 and TGF-beta [Time frame: Baseline and after 12 weeks]
Secondary outcome measures (3)
  • Change in FA, MD, AD and RD [Time frame: Baseline and after 12 weeks]
  • Change in cortical thickness as measured with FreeSurfer [Time frame: Baseline and after 12 weeks]
  • Change in glutamate in ACC and thalamus measured with MTI [Time frame: Baseline and after 12 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Denmark · 1 center
  • Mental Health Services Glostrup, Unit for Complicated Schizophrenia — Glostrup Municipality

Identifiers

NCT: NCT05316883 · BiCS2019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗