Biomarkers linked to clozapine response in schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study will recruit patients with treatment‑refractory schizophrenia who are eligible for clozapine and perform detailed neurobiological testing before treatment and after 12 weeks on clozapine. Baseline and follow‑up examinations include clinical ratings, blood inflammatory markers and autoantibodies, cerebrospinal fluid inflammatory markers, MRI of brain structure and spectroscopy (glutamate and GABA), blood–brain barrier permeability measures, and selected cognitive tests. Participants will receive clozapine according to national clinical guidelines and clinical response will be related to the biological measures. The goal is to identify clinical and biological characteristics that distinguish clozapine responders from non‑responders.

Why it matters

Who can join: the full rules

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

Where it's running

• Mental Health Services Glostrup, Unit for Complicated Schizophrenia
  Glostrup Municipality, Denmark, Denmark Recruiting

Study contacts

• Principal investigator: Jimmi Nielsen, PhD — Mental health Service, Glostrup
• Study coordinator: Jimmi Nielsen, PhD
• Email: jimmi.nielsen@regionh.dk
• Phone: 4538640885

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.