Mersey Care leads new study to test medications that treat side effects from anti-psychotic drugs

Mersey Care is leading a new clinical trial (GOTHIC2) which aims to test the effectiveness of medications in treating the side effects from antipsychotic drugs for schizophrenia.

Excessive drooling, or hypersalivation, is a common reaction to Clozapine, the most effective drug for ‘resistant’ schizophrenia. Stopping taking it is not always a viable option as it may lead to symptoms of schizophrenia becoming worse.

GOTHIC2 aims to investigate this issue, which is a major problem for patients, carers and clinicians, and plans to investigate alternative medications, hyoscine hydrobromide and glycopyrrolate, and compare them to a placebo in treating hypersalivation.

Mersey Care’s Chief Investigator, Dr Inti Qurashi, said: “Clozapine is often the only option for people with schizophrenia who have not responded to other medications. Although clozapine is effective in many cases it causes side effects, including hypersalivation, which occurs in up to 85% of patients.

“Excessive drooling is not only uncomfortable and unpleasant but can also lead patients to stop taking clozapine. Stopping clozapine in most cases leads to worsening mental illness symptoms and possible hospitalisation.

“There are currently no evidence-based treatments for hypersalivation caused by clozapine and the medication usually used, hyoscine, may not be effective. That is why this trial is important, to find an effective treatment for drooling caused by clozapine that does not add to the overall side-effect burden experienced by patients on clozapine.”

Hyoscine is commonly used to manage clozapine-induced hypersalivation, but researchers do not know if it works and it can cause unpleasant side effects such as bowel problems and mental acuity (for example, reducing attention span and ability to concentrate on tasks). Early evidence has shown glycopyrrolate may an effective treatment for hypersalivation and may cause fewer side effects, particularly those that affect thinking.

The study aims to recruit 252 patients on clozapine experiencing hypersalivation across England, and Dr Qurashi explained: “We have designed the study working closely with service users.

“By the end of the 48-month trial, we will have good evidence on the best treatment option for clozapine-induced hypersalivation and hope the study findings have a significant impact on improving the quality of life for patients prescribed clozapine.”

Service User Representative, Robert Bayley added: As a service user, diagnosed with treatment resistant schizophrenia since the 1980s, the only medication that has worked with any effectiveness, has been Clozapine. I’ve endured the accompanying hypersalivation for the duration of my treatment but have persisted.

“However, I have come close to cessation. So, the prospect of identifying a medication to contain this deeply distressing side effect is potentially pivotal and hugely important.”