Reducing Excess Salivation in clozapine Treatment: hyoscine for the treatment of clozapine induced nocturnal sialorrhoea
| ISRCTN | ISRCTN47146067 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47146067 |
| Protocol serial number | 1.0 |
| Sponsor | Kings College London - Joint Clinical Trials Office (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Biomedical Research Centre for Mental Health award, administered by the Institute of Psychiatry at Kings College London |
- Submission date
- 11/12/2009
- Registration date
- 16/03/2010
- Last edited
- 06/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr James MacCabe
Scientific
Scientific
Senior Lecturer
Department of Psychiatry
P063 Institute of Psychiatry
DeCrespigny Park
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 7848 0757 |
|---|---|
| j.maccabe@iop.kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre double blind randomised placebo controlled crossover trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Pilot double blind randomised placebo controlled crossover trial of hyoscine hydrobromide for the treatment of clozapine-induced nocturnal sialorrhoea |
| Study acronym | REST |
| Study objectives | This is a pilot study to obtain data on the efficacy of hyoscine hydrobromide 0.3 mg nocte in reducing nocturnal sialorrhoea in patients treated with clozapine. |
| Ethics approval(s) | South East Research Ethics Committee (REC) approved on the 22nd October 2009 (ref: 09/H1102/103) |
| Health condition(s) or problem(s) studied | Nocturnal sialorrhoea |
| Intervention | 1. Oral hyoscine hydrobromide 0.3 mg nocte for the treatment of nocturnal sialorrhoea in patients taking clozapine 2. Matching placebo The trial will consist of 2 washout periods of 1 week and two treatment phases of 4 weeks, totalling 10 weeks per participant. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Hyoscine hydrobromide, clozapine |
| Primary outcome measure(s) |
Score on the Toronto Nocturnal Hypersalivation Scale (TNHS), collected daily |
| Key secondary outcome measure(s) |
1. Overnight increase in mass of pillowcase, collected daily |
| Completion date | 31/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 12 |
| Total final enrolment | 14 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/01/2010 |
| Date of final enrolment | 31/03/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Senior Lecturer
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2019 | 06/10/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/10/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
26/09/2016: No publications found, verifying study status with principal investigator
