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NCT Number: NCT05316883

Biomarkers in Clozapine-responding Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychosis Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mental Health Services Glostrup, Unit for Complicated Schizophrenia

Glostrup Municipality, Denmark, 2600

Location status: Recruiting

Location contact

Bahast Biuk, MD

CONTACT

[email protected]

38640884

Mette Ødegaard Nielsen, MD, PhD

CONTACT

[email protected]

38640884

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clozapine

Drug

clinical doses adjusted to sideeffects and clinical effect

Primary outcomes

  1. Qalb

    Time frame: Baseline

    Quotient albumin (Qabl) in cerebrospinal fluid (CSF) compared to plasma

  2. Change in Qalb

    Time frame: Baseline and after 12 weeks

    Change in quotient albumin in cerebrospinal fluid compared to plasma

  3. Change in IL-6 and TGF-beta

    Time frame: Baseline and after 12 weeks

    Change in interleukin 6 (IL-6) and transcription growth factor beta (TGF-beta)

Secondary outcomes

  1. Change in FA, MD, AD and RD

    Time frame: Baseline and after 12 weeks

    Change in fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (AD) and radial diffusivity (RD)

  2. Change in cortical thickness as measured with FreeSurfer

    Time frame: Baseline and after 12 weeks

    Change in cortical thickness as measured with FreeSurfer

  3. Change in glutamate in ACC and thalamus measured with MTI

    Time frame: Baseline and after 12 weeks

    Change in glutamate in anterior cingulate cortex (ACC) and thalamus measured with magnetic transfer imaging (MTI)

Study contacts

Contact information is provided by the study sponsor or research team.

Jimmi Nielsen, PhD

CONTACT

[email protected]

4538640885

Mette Nielsen, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Jimmi Nielsen

Other

Registry information

Acronym: BiCS

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Apr 7, 2022
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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