RECRUITING

An Exploratory Analysis of Immune and Inflammatory Response Associated with Clozapine

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-08-16
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05741502

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All participants:
  2. * Between 18 and 65 years of age
  3. * Physically healthy (no clinically significant unstable medical condition as confirmed by medical history and physical examination)
  4. * Able to give informed consent
  5. * Treatment-Refractory Schizophrenia
  1. * Clinically significant medical condition; cardiovascular, pulmonary, endocrine, or renal condition requiring in depth medical treatment
  2. * Active or recent (within 4 weeks) bacterial or viral infection
  3. * Chronic viral infection (hepatitis, HIV)
  4. * History of autoimmune, or chronic inflammatory condition
  5. * Current treatment with lithium
  6. * Treatment with Clozapine in the past 6 months
  7. * Current treatment with immunomodulatory or anti-inflammatory therapy
  8. * Vaccination within the past 3 months
  9. * Current alcohol or substance use disorder of moderate or severe severity
  10. * Intellectual disability (i.e. intelligence quotient \<70)
  11. * Unwilling or unable to sign informed consent document
  12. * Pregnancy
  13. * Any patient deemed ineligible by PI discretion

Contacts and Locations

Study Contact

Walter H Stearns, MD
CONTACT
6146853221
walter.stearns@osumc.edu
Craig J Parris, MS
CONTACT
6146858623
craig.parris@osumc.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-16
Study Completion Date2026-06

Study Record Updates

Study Start Date2023-08-16
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Treatment-resistant Schizophrenia