Reducing Excess Salivation in clozapine Treatment: hyoscine for the treatment of clozapine induced nocturnal sialorrhoea

Pilot double blind randomised placebo controlled crossover trial of hyoscine hydrobromide for the treatment of clozapine-induced nocturnal sialorrhoea

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN47146067

Enrollment

Registered

2010-03-16

Start date

2010-01-02

Completion date

Unknown

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturnal sialorrhoea Digestive System Diseases of salivary glands

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 wash

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Score on the Toronto Nocturnal Hypersalivation Scale (TNHS), collected daily	—

Secondary

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026