Reducing Excess Salivation in clozapine Treatment: hyoscine for the treatment of clozapine induced nocturnal sialorrhoea

Not Applicable

Completed

• Conditions: octurnal sialorrhoea; Digestive System; Diseases of salivary glands

• Registration Number: ISRCTN47146067
• Lead Sponsor: Kings College London - Joint Clinical Trials Office (UK)

Brief Summary

2019 results in https://pubmed.ncbi.nlm.nih.gov/30614850 (added 06/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-16
• Study Completion: 2010-03-31
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Diagnosis of schizophrenia or schizoaffective disorder as per Diagnostic and Statistical Manual, Fourth Edition, Text Revision (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 Toronto Nocturnal Hypersalivation Scale (TNHS) on 4 occasions, in the 28 days prior to randomisation in the trial
6. Aged between 18 and 65 years of age, either sex
7. Capable of understanding the information given and giving fully informed consent prior to any study specific procedures

Exclusion Criteria

1. Medical conditions that could influence hypersalivation (e.g. idiopathic Parkinsons 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:
3.1. Prostatic enlargement
3.2. Myasthenia gravis
3.3. Pyloric stenosis
3.4. Paralytic ileus
3.5. Hypertension
3.6. Pregnancy
3.7. Tachycardia
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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score on the Toronto Nocturnal Hypersalivation Scale (TNHS), collected daily

Secondary Outcome Measures

Name	Time	Method
<br> 1. Overnight increase in mass of pillowcase, collected daily<br> 2. Change in diameter of wet area on pillowcase, collected daily<br> 3. Score on EQ-5D, collected daily<br>