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Clozapine and myocarditis

A case-control study to identify risk factors for myocarditis with clozapine

Senior Research Fellow and contact person: Dr Kathlyn Ronaldson

Phone: 03-9903-0840 or email

Download the study protocol (pdf 136kb)

Clozapine is the most effective treatment available for schizophrenia that has not responded to other therapies, but its use is limited because of serious adverse reactions.  One of those adverse reactions is myocarditis, or inflammation of the heart muscle.  In Australia, 264 cases of myocarditis with clozapine were reported to the Therapeutic Goods Administration (TGA) up to the end of 2008, and 26 reports have been received in New Zealand.  6% of the Australian cases were fatal.

At present there is no proven method for either predicting or preventing the development of myocarditis.  Our study is designed to identify risk factors.  Once we know what the risk factors are, it will be possible either to exclude from clozapine treatment those at high risk, or to monitor them more closely. 

Our study involves identifying cases of myocarditis at the psychiatric units around Australia and New Zealand and matching each of these to four control patients who have also been treated with clozapine at the same psychiatric unit but without developing myocarditis.  We will then obtain as much relevant information as we can about these patients, including age, sex, race, smoking status, use of illicit drugs, concurrent disease, other medication and dose of clozapine each day.  Where we are able to contact the patient and they give their consent, we also plan to take a blood sample so that we can look for a genetic marker for myocarditis.

We are hoping to include about 200 case patients and 800 controls.

The data will be analysed to look for factors that occur significantly more frequently among those with myocarditis than those without.



Ethics Committee Approvals


Progress Reports


Please tell us of any possible cases of myocarditis with clozapine, particularly if the cases occurred recently or they have not been reported to TGA.