SAIL databank analysis of Infection Related Outcomes in schizophrenia patients taking Clozapine (SIROC) Study

Public involvement and dissemination:

Schizophrenia is a common and devastating mental illness affecting 1 in 100 of the population. Clozapine was licensed as therapy over 30-years ago and remains the only effective anti-psychotic drug for patients with treatment-resistant schizophrenia. Despite saving lives by reducing suicide risk, people taking clozapine are at increased risk of chest infections and death from pneumonia.

We have recently led a study which showed that patients on clozapine therapy often show low levels of antibodies (known as 'IgG', 'IgA', and 'IgM') in blood. These proteins are important to fight off bacteria and viruses. Antibody deficiency may explain the increased risk of infections associated with clozapine-treatment. Patients taking clozapine already follow an intensive regimen of blood testing for the rare risk of agranulocytosis (1/100 cases). Antibody-level testing is not currently part of monitoring for these patients, therefore patients remain undiagnosed and at risk of infection.

Our team includes patients, mental health charities representatives, general practitioners, psychiatrists, immunologists, statisticians and the NHS Wales Informatics Service. Together we will achieve four key aims:

1. Offer individuals with schizophrenia receiving clozapine-treatment antibody-level testing alongside their routine blood testing. This will help them to access to appropriate protective vaccinations and where needed specialist assessment.
2. Using the SAIL-databank, which holds anonymous information on patients across-Wales, we will define the current burden from infection for these individuals and the healthcare system, comparing this to other individuals with chronic mental health issues, the general population, and those with known antibody-deficiency.
3. Develop new information technology (IT) tools to help flag-up patients whose routine NHS data suggests they have infections associated with antibody deficiency. This will help us to share results with clinicians and patients involved in this study in a meaningful way. It will also show that innovation in IT can help make sense of complex results and save time, supporting earlier diagnosis and treatment for patients with important or rare conditions.
4. Establish an archive of samples with consent from patients for use in future studies. This will include making use of leftover samples from routine blood tests, which would have otherwise simply have been thrown away. This will help shed light on our wider understanding of schizophrenia and the link to antibody-deficiency.

Public involvement and dissemination:

We have support from individuals with Schizophrenia, the Immune-deficiency Patient Group Wales (IDPGW), and the all-Wales mental health charity Hafal, (Chief Executive Alun Thomas). They will help shape how we setup and run this study. We will feedback findings to those contributing. Understanding the health economics will inform policy decisions and healthcare planning in Wales at a national level. We will also present and publish our results in peer-reviewed journals and conferences to share lessons learnt in Wales across the world.