A Prospective, Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

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 prospectively track them over the course of 4 months in 4 week intervals along with rating scales for psychosis and suicidality, the other entities which Clozapine has been shown to improve.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Treatments: Antipsychotic Agents; Aripiprazole; Cariprazine; Clozapine; Lurasidone Hydrochloride; Olanzapine; Paliperidone Palmitate; Quetiapine Fumarate; Risperidone; Ziprasidone

Criteria

Inclusion Criteria:

• All participants:

• Between 18 and 40 years of age

• Physically healthy (no clinically significant medical condition as confirmed by medical history and physical examination)

• Able to give informed consent

• Treatment-Refractory Schizophrenia

Clozapine treatment group (n = 30)

• Newly initiating treatment with Clozapine for the first time and have not yet been given more than 4 days (96 hours) of the Clozapine before initial lab work obtained Non-Clozapine treatment, active comparator group (n = 30)

• Continued treatment with non-Clozapine antipsychotic but would be eligible for Clozapine with the provider/patient electing to not pursue such for clinical reasons

Exclusion Criteria:

• 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