clozapine-induced hypersalivation - feasibility trial
Research type
Research Study
Full title
GOTHIC1: A feasibility trial of glycopyrrolate in comparison to hyoscine hydrobromide and placebo in the treatment of clozapine-induced hypersalivation
IRAS ID
172540
Contact name
Inti Qurashi
Contact email
Sponsor organisation
Mersey Care NHS Trust
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
For some people with schizophrenia the only medicine that alleviates their symptoms is an antipsychotic medication called clozapine but unfortunately it also causes many people to produce far too much saliva (hypersalivation). A survey of people taking clozapine within Mersey Care NHS Trust found hypersalivation to be the most unacceptable side effect of clozapine; it is an embarrassing and socially stigmatizing side-effect causing social withdrawal and disturbed sleep. Hyoscine hydrobromide is usually prescribed to treat hypersalivation but there is no convincing information about how effective it is. Hyoscine also causes side-effect that cause problems (e.g. confusion, poor concentration) which may contribute to a poorer long-term outcome for patients with schizophrenia. There have been encouraging results from small studies investigating a medication called glycopyrrolate for the treatment of hypersalivation.
Although the evidence indicates it may be effective, its use may be limited by side effects and patients have not been asked which medication they would prefer if different treatments were similarly effective. In the longer term we want to conduct a large clinical trial to examine several important issues; which (if any) of the two medicines, hyoscine hydrobromide and glycopyrrolate, is most effective in treating hypersalivation? Which medication causes the least thinking side effects? Which medication do patients prefer? We propose to conduct a preliminary (feasibility) study to answer some important questions to inform the design of a larger future trial. These are:
1. Will our proposed study design be acceptable to potential participants?
a) Are patients willing to join such a study?
b) Are the medications tolerated by participants, if they drop out what are the reasons and what can we change?
2. Are the hypersalivation assessments suitable for use in a UK population and how many participants will we need in a future large randomised controlled trial?REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
15/NW/0823
Date of REC Opinion
26 Nov 2015
REC opinion
Favourable Opinion