Study of Clozapine Treatment and Biomarkers in Adults with Treatment-Resistant Schizophrenia or Related Psychoses

What this Trial Is About

This research aims to identify clinical and biological markers in patients with treatment-resistant schizophrenia who are eligible for clozapine treatment. The study focuses on patients with schizophrenia or related psychoses who have not responded adequately to at least two antipsychotic drugs. The goal is to understand which patients respond to clozapine by examining immunological markers, autoantibodies, and brain changes. Participants will receive open-label clozapine treatment, with doses adjusted based on side effects and clinical response. Before starting treatment, patients will undergo detailed neurobiological exams, including blood and cerebrospinal fluid tests and magnetic resonance imaging MRI. After 12 weeks of treatment, these examinations will be repeated to assess changes. During the study, participants will have clinical ratings, blood tests for inflammatory markers, cerebrospinal fluid analysis, MRI scans focusing on brain structure and chemistry, and selected cognitive tests. Researchers will measure changes in specific immune markers and brain imaging features from baseline to 12 weeks. The total study period includes baseline assessments, 12 weeks of treatment, and follow-up evaluations to monitor treatment effects and safety.

Biomarkers in Clozapine-responding Schizophrenia