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 个研究点目标入组 14 人开始时间: 2010年3月16日最近更新: 2020年10月19日

适应症

试验速览

•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

•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

发起方

Kings College London - Joint Clinical Trials Office (UK)