NCT05741502TerminatedPhase 4
An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine
An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine Versus Non-Clozapine Antipsychotics in Individuals With Treatment-resistant Schizophrenia
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Reason given: Not able to recruit enough subjects
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 20 Jan 2023
- Start date
- 16 Aug 2023
- Primary completion date
- 23 Jan 2026
- Lead sponsor
- Ohio State University
- Diseases
- Schizophrenia
- NCT number
- NCT05741502
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with lithium
- Treatment with Clozapine in the past 6 months
- Current treatment with immunomodulatory or anti-inflammatory therapy
Other illness
- 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 alcohol or substance use disorder of moderate or severe severity
Other
- Vaccination within the past 3 months
- Intellectual disability (i.e. intelligence quotient <70)
- Unwilling or unable to sign informed consent document
- Pregnancy
- Any patient deemed ineligible by PI discretion
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ohio State University Harding Hospital | Columbus | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.