Clozapine and hypogammaglobulinaemia
Research type
Research Study
Full title
An Investigation into the effect of Clozapine treatment on the level of serum immunoglobulins
IRAS ID
104402
Contact name
Stephen Jolles
Contact email
Sponsor organisation
University Hospital of Wales
Research summary
The anti-psychotic Clozapine is known to cause deficits in some immunological markers, e.g. low or absent white blood cell count. It has been suggested that Clozapine may also affect the level of antibodies (immunoglobulins), suggested from following a study into calculated globulin as a potential screening tool for antibody deficiency. Monitoring of immunoglobulin levels is not currently part of the routine Clozapine follow up. This study will investigate the hypothesis that the use of regular Clozapine (such as is used in schizophrenia) may cause antibody deficiency.
Patients on regular Clozapine require frequent blood tests to ensure that Clozapine dose is not at a toxic level in the blood, alongside other routine monitoring blood tests. For this study an additional blood sample will be collected (4ml) at the same time as routine samples are taken. This additional sample will be tested for immunoglobulins. The clinic staff will complete a short questionnaire on behalf of the patient and the patient will complete a consent form. We aim to collect data on the patients known to be receiving Clozapine in this HB (approx 280). The information regarding immunoglobulin levels will be correlated with infection frequency and other information collected via the questionnaire.
The data from these collected blood samples and questionnaires will be analysed to ascertain if there is a correlation between the use of Clozapine and a reduction in immunoglobulins.
If a positive correlation is discovered an unknown side effect of Clozapine will have been discovered. This information will be important in patient treatment, monitoring and aid in preventing infectious or immunological problems.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
13/EM/0209
Date of REC Opinion
24 May 2013
REC opinion
Further Information Favourable Opinion