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
Guys Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
+44 (0)20 7188 9574
enquiries@jcto.co.uk
Sponsor type
University/education
Website
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 Kings 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