Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT05741502
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05741502
Study Brief:
Protocol Section:
NCT05741502