An Exploratory Analysis of Immune and Inflammatory Response Associated with Clozapine

Description

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.

Conditions

Treatment-resistant Schizophrenia

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Study Overview

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Study Details

Study overview

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.

An Exploratory Analysis of Immune and Inflammatory Response Associated with Clozapine Versus Non-Clozapine Antipsychotics in Individuals with Treatment-resistant Schizophrenia

An Exploratory Analysis of Immune and Inflammatory Response Associated with Clozapine

Condition
Treatment-resistant Schizophrenia
Intervention / Treatment

-

Contacts and Locations

Columbus

Ohio State University Harding Hospital, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ohio State University,

Study Record Dates

2026-06