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

ISRCTN ISRCTN47146067
DOI https://doi.org/10.1186/ISRCTN47146067
Secondary identifying numbers 1.0
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

Senior Lecturer
Department of Psychiatry
P063 Institute of Psychiatry
DeCrespigny Park
London
SE5 8AF
United Kingdom

Phone +44 (0)20 7848 0757
Email j.maccabe@iop.kcl.ac.uk

Study information

Study designSingle centre double blind randomised placebo controlled crossover trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePilot double blind randomised placebo controlled crossover trial of hyoscine hydrobromide for the treatment of clozapine-induced nocturnal sialorrhoea
Study acronymREST
Study objectivesThis 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) studiedNocturnal sialorrhoea
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Hyoscine hydrobromide, clozapine
Primary outcome measureScore on the Toronto Nocturnal Hypersalivation Scale (TNHS), collected daily
Secondary outcome measures1. Overnight increase in mass of pillowcase, collected daily
2. Change in diameter of wet area on pillowcase, collected daily
3. Score on EQ-5D, collected daily
Overall study start date02/01/2010
Completion date31/03/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants12
Total final enrolment14
Key inclusion criteria1. 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 criteria1. 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 enrolment02/01/2010
Date of final enrolment31/03/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Senior Lecturer
London
SE5 8AF
United Kingdom

Sponsor information

Kings College London - Joint Clinical Trials Office (UK)
University/education

3rd floor, Conybeare House
Guy’s Hospital
Great Maze Pond
London
SE1 9RT
England
United Kingdom

Phone +44 (0)20 7188 9574
Email enquiries@jcto.co.uk
Website http://jcto.co.uk
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Biomedical Research Centre for Mental Health award, administered by the Institute of Psychiatry at King’s College London

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

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