Sialorrhoea in patients treated with clozapine. MedDRA version: 12.0 Level: LLT Classification code 10059812 Term: Sialorrhoea
Conditions
Interventions
Trade Name: Kwells
Product Name: Kwells 300 microgram tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Scopolamine hydrobromide
CAS Number: 114-49-8
Other descriptive name: Hyoscine Hydrobromi
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. To investigate whether quality of life is enhanced by treatment with Hyoscine 0.3mg nocte in patients taking Clozapine with nocturnal sialorrhoea. 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. ;Primary end point(s): Score on the Toronto Nocturnal Hypersalivation Scale each morning | — |
Countries
United Kingdom
Outcome results
None listed