EUCTR2009-016300-23-GB
Active, not recruiting
Not Applicable
Pilot double blind randomised placebo controlled crossover trial of Hyoscine for the treatment of Clozapine induced nocturnal sialorrhoea. - Reducing Excess Salivation Trial (REST)
ConditionsSialorrhoea in patients treated with clozapine.MedDRA version: 12.0Level: LLTClassification code 10059812Term: Sialorrhoea
DrugsKwells
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sialorrhoea in patients treated with clozapine.
- Sponsor
- King's College London
- Enrollment
- 12
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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