Condition category
Digestive System
Date applied
11/12/2009
Date assigned
16/03/2010
Last edited
26/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr James MacCabe

ORCID ID

Contact details

Senior Lecturer
Department of Psychiatry
P063 Institute of Psychiatry
DeCrespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0757
j.maccabe@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

Pilot double blind randomised placebo controlled crossover trial of hyoscine hydrobromide for the treatment of clozapine-induced nocturnal sialorrhoea

Acronym

REST

Study hypothesis

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

South East Research Ethics Committee (REC) approved on the 22nd October 2009 (ref: 09/H1102/103)

Study design

Single centre double blind randomised placebo controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Hyoscine hydrobromide, clozapine

Primary outcome measures

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

Secondary outcome measures

1. 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 trial start date

02/01/2010

Overall trial end date

31/03/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12

Participant 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

Recruitment start date

02/01/2010

Recruitment end date

31/03/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Senior Lecturer
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

Kings College London - Joint Clinical Trials Office (UK)

Sponsor details

3rd floor
Conybeare House
Guy’s Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
+44 (0)20 7188 9574
enquiries@jcto.co.uk

Sponsor type

University/education

Website

http://jcto.co.uk

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/09/2016: No publications found, verifying study status with principal investigator