GOTHIC2
Research type
Research Study
Full title
A multi-centre randomised placebo-controlled trial of glycopyrrolate and hyoscine hydrobromide for the treatment of clozapine-induced hypersalivation
IRAS ID
1008055
Contact name
Inti Qurashi
Contact email
Sponsor organisation
University of Liverpool
ISRCTN Number
ISRCTN36536677
Research summary
Clozapine is an antipsychotic medication used to help treat the symptoms of schizophrenia and is also sometimes used to treat other mental health conditions. It is the most effective antipsychotic medication for many people and it is important to keep taking it. Clozapine can cause different side effects and people tell us one of the most upsetting is excessive drooling. Doctors call this ‘clozapine-induced hypersalivation’ (CIH or drooling). People with CIH/drooling tell us they often have to wipe the saliva from their mouth during the day and their pillow becomes very wet at night which can sometimes make the skin on their face sore. CIH can be very embarrassing and lead to some patients wanting to stop clozapine treatment. For most patients this is not a good idea as their mental illness is likely to come back and they may need to be admitted to hospital. Currently there is no proven treatment for CIH. The medication usually prescribed is called hyoscine but we don’t know if hyoscine helps although doctors think it might. Hyoscine can cause unpleasant side effects such as bowel problems (constipation) and thinking problems (making attention and concentration worse). Some studies suggest a different medication called glycopyrrolate might be helpful for CIH and may cause fewer thinking problems. But it may still cause other side effects like constipation. Patients have told us that it is important for them to know which medications may improve CIH and what the side effects are so they can make an informed choice about whether or not to take any of these medicines based on their mental illness symptoms and experience of side-effects. Our study will find out if either hyoscine or glycopyrrolate can improve CIH/drooling by comparing patients taking these medications with patients taking a dummy treatment (placebo). If both help reduce CIH/drooling we will compare the two medications to see which one causes fewer side effects and ask which one patients prefer.
REC name
London - Fulham Research Ethics Committee
REC reference
23/LO/1002
Date of REC Opinion
26 Jan 2024
REC opinion
Further Information Favourable Opinion