Pilot double blind randomised placebo controlled crossover trial of Hyoscine for the treatment of Clozapine induced nocturnal sialorrhoea. - Reducing Excess Salivation Trial (REST)

Conditions: Sialorrhoea in patients treated with clozapine.
MedDRA version: 12.0Level: LLTClassification code 10059812Term: Sialorrhoea

Registration Number: EUCTR2009-016300-23-GB

Lead Sponsor: King's College London

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 12

Inclusion Criteria

1.Diagnosis of Schizophrenia or Schizoaffective disorder as per DSM IV-TR criteria.
2.Receiving clozapine for at least two weeks
3.Clozapine dose in the range 200 – 900 mg per day.
4.Able to speak English.
5.Have a minimum score of 2 on the TNHS prior to inclusion in the trial.
6. Adults aged between 18 and 65 years of age
7.Capable of understanding the information given and giving fully informed consent prior to any study specific procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Medical conditions that could influence hypersalivation (e.g. idiopathic Parkinson’s Disease).
2.History of an allergic reaction to hyoscine hydrobromide.
3.Any of the following contra-indications to hyoscine as stated in the British National Formulary and electronic Medicines Compendium:
Prostatic enlargement, myasthenia gravis, pyloric stenosis, paralytic ileus, glaucoma and pregnancy (see appendix C).
4.A woman of childbearing potential, who has tested negative for pregnancy, unable or unwilling to use appropriate contraception during the study.
5.Participation in another therapeutic study within the preceding 12 weeks or use of other investigational drugs or agents.
6.Lack of capacity to provide informed consent to the proposed intervention.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This is a pilot study to obtain data on the efficacy of Hyoscine 0.3mg nocte in reducing salivation at night in patients treated with Clozapine. ;Secondary Objective: To monitor the safety of Hyoscine 0.3mg nocte in patients taking Clozapine with nocturnal sialorrhoea.<br>To investigate whether quality of life is enhanced by treatment with Hyoscine 0.3mg nocte in patients taking Clozapine with nocturnal sialorrhoea.<br>To pilot a two new methods of estimating the extent of nocturnal sialorrhoea, by measuring the diameter of the wet patch and the change in mass of the patient’s pillowcase overnight. <br>;Primary end point(s): Score on the Toronto Nocturnal Hypersalivation Scale each morning

Secondary Outcome Measures