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11 February 2012
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| [ Print-friendly version ] |
| Reducing Excess Salivation in clozapine Treatment: hyoscine for the treatment of clozapine induced nocturnal sialorrhoea |
| ISRCTN | ISRCTN47146067 |
| ClinicalTrials.gov identifier | |
| Public title | Reducing Excess Salivation in clozapine Treatment: hyoscine for the treatment of clozapine induced nocturnal sialorrhoea |
| Scientific title | Pilot double blind randomised placebo controlled crossover trial of hyoscine hydrobromide for the treatment of clozapine-induced nocturnal sialorrhoea |
| Acronym | REST |
| Serial number at source | 1.0 |
| 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. |
| Lay summary | |
| Ethics approval |
South East Research Ethics Committee (REC) approved on the 22nd October 2009 (ref: 09/H1102/103)
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| Study design | Single centre double blind randomised placebo controlled crossover trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Nocturnal sialorrhoea |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 02/01/2010 |
| Anticipated end date | 31/03/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 12 |
| Interventions |
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. |
| Primary outcome measure(s) | Score on the Toronto Nocturnal Hypersalivation Scale (TNHS), collected daily |
| Secondary outcome measure(s) |
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 |
| Sources of funding | 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 |
| Trial website | |
| Publications | |
| Contact name | Dr James MacCabe |
| Address |
Senior Lecturer
Department of Psychiatry P063 Institute of Psychiatry DeCrespigny Park |
| City/town | London |
| Zip/Postcode | SE5 8AF |
| Country | United Kingdom |
| Tel | +44 (0)20 7848 0757 |
| j.maccabe@iop.kcl.ac.uk | |
| Sponsor | Kings College London - Joint Clinical Trials Office (UK) |
| Address |
3rd floor, Conybeare House
Guy’s Hospital Great Maze Pond |
| City/town | London |
| Zip/Postcode | SE1 9RT |
| Country | United Kingdom |
| Tel | +44 (0)20 7188 9574 |
| Fax | +44 (0)20 7188 8330 |
| enquiries@jcto.co.uk | |
| Sponsor website: | http://jcto.co.uk |
| Date applied | 11/12/2009 |
| Last edited | 07/05/2010 |
| Date ISRCTN assigned | 16/03/2010 |
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