Zaro-002
Research type
Research Study
Full title
AN OBSERVATIONAL STUDY INTO THE EFFECT OF CLOZAPINE AND OTHER ANTIPSYCHOTIC TREATMENT ON CIRCULATING B CELLS
IRAS ID
250864
Contact name
Edward Silva
Contact email
Sponsor organisation
Zarodex Therapeutics Limited
Duration of Study in the UK
0 years, 3 months, 5 days
Research summary
1. Study title: An observational study into the effect of clozapine and other antipsychotic treatment on circulating B cells.
2. Short title: A study investigating the effect of antipsychotic medication on the immune system.
3. Background to the study
Antipsychotic medication is associated with several adverse effects. For some of these, including clozapine used mainly for treatment-resistant schizophrenia, this includes an increased risk of infection. The reasons for this are not fully understood, but may include low antibody levels.
4. Study aims and importance
This study will look at the effects of antipsychotic medication on the immune system, specifically the part that makes antibodies, called B cells.
This may help us see if some of these medications cause a low level of immunity and so help improve care and reduce risk of infections, for example by checking effects on this part of the immune system. The study might also lead to other uses for clozapine in diseases caused by this part of the immune system (such as rheumatoid arthritis) where B cell function is a problem.
5. Who would be eligible?
Patients on clozapine or any other antipsychotic medication.
6. Where will the study be carried out?
Ashworth Hospital and at community mental health services in Mersey Care NHS Foundation Trust.
7. What will the participants undergo?
a) Participants will be requested to provide a single blood test to measure types of white blood cells and antibody levels. wherever possible this will be times with other routine blood sampling, e.g. as part of routine clozapine monitoring.
and
b) participants will be asked questions about prior infections and antibiotic use.
8. How long will the study last?
For each individual participant the blood sampling and asking of questions will be undertaken once.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
18/NW/0540
Date of REC Opinion
3 Oct 2018
REC opinion
Further Information Favourable Opinion