Using Tocilizumab to treat schizophrenia
A Randomized Controlled Trial of Adjunctive Tocilizumab in Schizophrenia
This study is testing if adding the anti-inflammatory drug Tocilizumab to the usual treatment can help improve thinking skills in people with stable schizophrenia who have high inflammation levels.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Augusta University Academic / other |
| Drugs / interventions | Tocilizumab, siltuximab |
| Locations | 1 site (Augusta, Georgia) |
| Trial ID | NCT02874573 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial investigates the safety, tolerability, and efficacy of Tocilizumab, an anti-inflammatory medication, as an adjunct treatment for stable outpatients with schizophrenia. The study involves a 12-week randomized controlled design with 20 participants who have elevated inflammation markers in their blood. Participants will receive Tocilizumab via intravenous infusion alongside their current antipsychotic medications to assess improvements in cognitive function. The trial aims to explore the relationship between inflammation and cognitive impairment in schizophrenia.
Who should consider this trial
Good fit: Ideal candidates are stable outpatients aged 18-55 with a diagnosis of schizophrenia or schizoaffective disorder and evidence of increased inflammation.
Not a fit: Patients who are currently in danger to themselves or others, or those with certain medical conditions or recent antibiotic use, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved cognitive function and overall quality of life for patients with schizophrenia.
How similar studies have performed: Previous studies have shown some success with anti-inflammatory treatments in schizophrenia, but this specific approach using Tocilizumab is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * male and female * age 18-55 * capable of giving informed consent * Diagnostic and Statistical Manual of Mental Disorders (DSM)-V diagnosis of schizophrenia or schizoaffective disorder * stable based on clinical judgment, no psychiatric hospitalizations in past 3 months, and on the same psychotropic medications for \>4 weeks * taking a non-clozapine antipsychotic * 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 tuberculosis * low absolute neutrophil (\<2000) or platelet (\<100,000) count * abnormal hepatic (AST or ALT \>1.5 times the upper limit of normal) or renal (BUN or creatinine\>1.5 times the upper limit of normal) function * any abnormal lab test result judged to be clinically significant * active, chronic or recurrent infections * pregnancy * breast feeding * female and of child-bearing potential who is not using any contraception
Where this trial is running
Augusta, Georgia
- Augusta University — Augusta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Brian J Miller, MD — Augusta University
- Study coordinator: Brian J Miller, MD
- Email: brmiller@augusta.edu
- Phone: 706-721-4445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.