Biomarkers in Clozapine-responding Schizophrenia

Schizophrenia Clinical Trial

— BiCS  

Official title:

Biomarkers in Clozapine-responding Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05316883
• Other study ID #: BiCS2019
• Status: Recruiting
• Phase: Phase 4
• Start date: February 28, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2022
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Jimmi Nielsen, PhD
• Phone: 4538640885
• Email: jimmi.nielsen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychosis
• Schizophrenia

Intervention

Drug:
• Clozapine
clinical doses adjusted to sideeffects and clinical effect

Locations

Country	Name	City	State
Denmark	Mental Health Services Glostrup, Unit for Complicated Schizophrenia	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qalb	Quotient albumin (Qabl) in cerebrospinal fluid (CSF) compared to plasma	Baseline
Primary	Change in Qalb	Change in quotient albumin in cerebrospinal fluid compared to plasma	Baseline and after 12 weeks
Primary	Change in IL-6 and TGF-beta	Change in interleukin 6 (IL-6) and transcription growth factor beta (TGF-beta)	Baseline and after 12 weeks
Secondary	Change in FA, MD, AD and RD	Change in fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (AD) and radial diffusivity (RD)	Baseline and after 12 weeks
Secondary	Change in cortical thickness as measured with FreeSurfer	Change in cortical thickness as measured with FreeSurfer	Baseline and after 12 weeks
Secondary	Change in glutamate in ACC and thalamus measured with MTI	Change in glutamate in anterior cingulate cortex (ACC) and thalamus measured with magnetic transfer imaging (MTI)	Baseline and after 12 weeks