ISRCTN47146067
Completed
未知
Pilot double blind randomised placebo controlled crossover trial of hyoscine hydrobromide for the treatment of clozapine-induced nocturnal sialorrhoea
Kings College London - Joint Clinical Trials Office (UK)0 sites14 target enrollmentMarch 16, 2010
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- octurnal sialorrhoea
- Sponsor
- Kings College London - Joint Clinical Trials Office (UK)
- Enrollment
- 14
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2019 results in https://pubmed.ncbi.nlm.nih.gov/30614850 (added 06/10/2020)
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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