An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine
Summary
The specific aim of this protocol is to compare Clozapine treatment vs Non-Clozapine antipsychotic treatment in a population of treatment-refractory individuals with schizophrenia. Specifically, it is to test if Clozapine leads to a decrease in levels of inflammatory markers, namely interleukin-6 but with an exploratory view of other markers. Clozapine has superior efficacy and is the only medication approved for treatment-refractory schizophrenia in addition to decreasing the risk of suicidal behavior as well. It is unclear why Clozapine has increased efficacy from a mechanistic viewpoint. We will look at the role of inflammatory markers and assess them 1x along with rating scales for psychosis and suicidality, the other entities which Clozapine has been shown to improve.
Timeline
- Start
- 2023-08-16
- Primary completion
- 2026-01-23
- Completion
- 2026-01-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aripiprazole | Other / unclassified | — | — |
| Comparator | Cariprazine | Small molecule | — | — |
| Subject | Clozapine | Other / unclassified | — | — |
| Comparator | Lurasidone | Small molecule | — | — |
| Comparator | Olanzapine | Small molecule | — | — |
| Comparator | Paliperidone | Unknown | — | — |
| Comparator | Quetiapine | Small molecule | — | — |
| Comparator | Risperidone | Other / unclassified | — | — |
| Comparator | Ziprasidone | Small molecule | — | — |