NCT05316883

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline
44mo left

Started Feb 2021

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Feb 2021Dec 2029

First Submitted

Initial submission to the registry

September 30, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

February 28, 2021

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

8.8 years

First QC Date

September 30, 2020

Last Update Submit

January 16, 2026

Conditions

SchizophreniaPsychosis

Outcome Measures

Primary Outcomes (3)

  • Qalb

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

    Baseline

  • Change in Qalb

    Change in quotient albumin in cerebrospinal fluid compared to plasma

    Baseline and after 12 weeks

  • 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 Outcomes (3)

  • Change in FA, MD, AD and RD

    Baseline and after 12 weeks

  • Change in cortical thickness as measured with FreeSurfer

    Baseline and after 12 weeks

  • Change in glutamate in ACC and thalamus measured with MTI

    Baseline and after 12 weeks

Study Arms (1)

clozapine treatment

OTHER

Open label clozapine will be given to all participants in clinical doses adjusted to sideeffects and clinical effect

Drug: Clozapine

Interventions

ClozapineDRUG

clinical doses adjusted to sideeffects and clinical effect

clozapine treatment

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Services Glostrup, Unit for Complicated Schizophrenia

Glostrup Municipality, Denmark, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Clozapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jimmi Nielsen, PhD

    Mental health Service, Glostrup

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jimmi Nielsen, PhD

CONTACT

4538640885jimmi.nielsen@regionh.dk

Mette Nielsen, PhD

CONTACT

mette.oedegaard.nielsen@regionh.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: To compare biomarkers between clozapine responders and non-responder before and after 12 weeks of treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 30, 2020

First Posted

April 7, 2022

Study Start

February 28, 2021

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)