Comparing Clozapine and Non-Clozapine Treatments for Schizophrenia

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

This study is testing whether Clozapine can help people with treatment-resistant schizophrenia feel better and reduce inflammation compared to other antipsychotic medications.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ohio State University (other)
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT05741502 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effects of Clozapine treatment versus non-Clozapine antipsychotic treatment in individuals with treatment-resistant schizophrenia. It will specifically investigate whether Clozapine leads to a reduction in inflammatory markers, particularly interleukin-6, while also assessing psychosis and suicidality ratings. Participants will include stable outpatients who have been on Clozapine for at least six months and a comparator group on non-Clozapine antipsychotics. The study involves a single visit for symptom assessments and laboratory tests to collect biomarker data.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with treatment-resistant schizophrenia who have been on Clozapine or non-Clozapine antipsychotics for at least six months.

Not a fit: Patients with clinically significant medical conditions, active infections, or a history of autoimmune or chronic inflammatory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the mechanisms behind Clozapine's efficacy, potentially leading to improved treatment strategies for patients with treatment-resistant schizophrenia.

How similar studies have performed: Other studies have explored the relationship between antipsychotic treatment and inflammatory markers, but this specific comparison of Clozapine versus non-Clozapine treatments is relatively novel.

Eligibility criteria

Inclusion 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

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

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

Where this trial is running

Columbus, Ohio

• Ohio State University Harding Hospital — Columbus, Ohio, United States (RECRUITING)

Study contacts

• Study coordinator: Walter H Stearns, MD

Conditions: Treatment-resistant Schizophrenia