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

2021H0388

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.

2023-08-16

2026-03-01

2026-06-01

Recruiting

Early phase I

60

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel open-label groups of Treatment-Refractory schizophrenia patients treated with Clozapine or non-Clozapine drug', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-10-06