Reducing Excess Salivation Trial, Version 1.0

• Research type

  Research Study

• Full title

  Pilot double blind randomised placebo controlled crossover trial of Hyoscine for the treatment of Clozapine induced nocturnal sialorrhoea.

• IRAS ID

  23162

• Sponsor organisation

  King's College London

• Eudract number

  2009-016300-23

• ISRCTN Number

  pending

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  One of the most effective medications for psychosis (clozapine) causes many patients to produce excessive saliva. This is embarrassing and occasionally life threatening. Another team of researchers found it to be the most troublesome side effect of clozapine by far, especially at night. We will conduct a small clinical trial (pilot study) to examine the benefits of a medicine called hyoscine to combat this problem. Many people are familiar with its trade name ??Quells? as a remedy for travel sickness. Part of its action includes slowing the rate at which our mouths produce saliva. We want to focus on hyoscine because, while it is often used for this problem, there are no scientific studies offering proof that it is effective. We intend to invite twelve patients who been prescribed clozapine and who suffer from excessive salivation, to take part in this study. We will give participants either a capsule with hyoscine in or an identical capsule with no active ingredient in (a placebo) every evening for 4 weeks. After a break of 1 week, participants will receive the other type of capsule (active drug or placebo) for a further four weeks. We will measure the amount of saliva that each patient produces each morning and we will ask them whether the problem has improved or not each week. Together this information will tell us whether the hyoscine has helped to reduce the amount of saliva produced at night or not. One completed we intend to write about our findings in a scientific journal.

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/103

• Date of REC Opinion

  22 Oct 2009

• REC opinion

  Favourable Opinion