An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine
Stopped early · Phase 4
Conditions studied: Treatment-resistant Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT05741502
- Run by
- Ohio State University
- People needed
- 5
- Starts
- 2023-08-16
- Expected to finish
- 2026-01-23
- Last updated by the study team
- 2026-02-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All participants:
- Between 18 and 65 years of age
- Physically healthy (no clinically significant unstable medical condition as confirmed by medical history and physical examination)
- Able to give informed consent
- Treatment-Refractory Schizophrenia
- Clozapine treatment group (n = 30) Individuals treated with Clozapine consistently for a minimum of 6 months
- Non-Clozapine treatment group Continued treatment with non-Clozapine antipsychotic but would be eligible for Clozapine with the provider/patient electing to not pursue such for clinical reasons, consistently treated for at least 6 months
You may not qualify if…
- Clinically significant medical condition; cardiovascular, pulmonary, endocrine, or renal condition requiring in depth medical treatment
- Active or recent (within 4 weeks) bacterial or viral infection
- Chronic viral infection (hepatitis, HIV)
- History of autoimmune, or chronic inflammatory condition
- Current treatment with lithium
- Treatment with Clozapine in the past 6 months
- Current treatment with immunomodulatory or anti-inflammatory therapy
- Vaccination within the past 3 months
- Current alcohol or substance use disorder of moderate or severe severity
- Intellectual disability (i.e. intelligence quotient <70)
- Unwilling or unable to sign informed consent document
- Pregnancy
- Any patient deemed ineligible by PI discretion
Where it is running
- Ohio State University Harding Hospital — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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