Pilot double blind randomised placebo controlled crossover trial of Hyoscine for the treatment of Clozapine induced nocturnal sialorrhoea. - Reducing Excess Salivation Trial (REST)

King's College London0 个研究点目标入组 12 人开始时间: 2009年11月9日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1.Diagnosis of Schizophrenia or Schizoaffective disorder as per 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 TNHS prior to inclusion in the trial.
•6. Adults aged between 18 and 65 years of age
•7.Capable of understanding the information given and giving fully informed consent prior to any study specific procedures.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Medical conditions that could influence hypersalivation (e.g. idiopathic Parkinson’s 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:
•Prostatic enlargement, myasthenia gravis, pyloric stenosis, paralytic ileus, glaucoma and pregnancy (see appendix C).
•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.

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