An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine (NCT05741502) | Clinical Trial Compass
TerminatedPhase 4
An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine
Stopped: Not able to recruit enough subjects
United States5 participantsStarted 2023-08-16
Plain-language 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 assess them 1x along with rating scales for psychosis and suicidality, the other entities which Clozapine has been shown to improve.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.