Siltuximab in Schizophrenia

Launched by BRIAN MILLER · Jun 10, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Siltuximab to see if it can help improve cognitive function in people with schizophrenia. It is specifically looking at patients who are already stable on their antipsychotic medications but have signs of increased inflammation in their blood. The study will involve 30 participants who will receive Siltuximab through an intravenous infusion every three weeks over a period of nine weeks. Researchers hope to find out if this medication can help improve thinking skills compared to a placebo, which is a harmless substance that looks like the medication but has no active ingredients.

To be eligible for this trial, participants should be between the ages of 18 and 75, have a diagnosis of schizophrenia or schizoaffective disorder, and have been on the same non-clozapine antipsychotic medication for at least four weeks. They should also have a specific blood marker indicating inflammation. However, those with certain medical conditions, recent infections, or who are pregnant cannot participate. Throughout the study, participants will be monitored for any changes in their symptoms and cognitive abilities. This trial aims to explore a new approach to treating schizophrenia by targeting inflammation in the body.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • capable of giving informed consent
• • diagnosis of schizophrenia or schizoaffective disorder
• • stable based on clinical judgment
• • taking a non-clozapine antipsychotic
• • on the same psychotropic medications for \>4 weeks
• • hsCRP \>0.3 mg/dL at the screening visit
• Exclusion Criteria:
• • imminent danger to self/others
• • antibiotic use in the past 2 weeks
• • current scheduled use of immunomodulatory agents
• • history of an immune disorder
• • illicit drug use in the past 30 days
• • any unstable or untreated medical condition
• • history of gastrointestinal ulcers, diverticulitis, malignancy, CNS demyelinating disorder, seizure disorder, or exposure to tuberculosis
• • low absolute neutrophil (\<2000) or platelet (\<100,000) count
• • abnormal hepatic function (AST or ALT \>1.5 times the upper limit of normal) or renal function (BUN or creatinine \>1.5 times the upper limit of normal)
• • any abnormal lab test result judged to be clinically significant
• • active or chronic infections
• • pregnancy, breast feeding, or female of child-bearing potential who is not using any contraception.