A trial of medications in comparison to dummy tablets for the treatment of drooling caused by clozapine.
- Conditions
- Clozapine induced hypersalivation (CIH)Mental and Behavioural Disorders
- Registration Number
- ISRCTN36536677
- Lead Sponsor
- niversity of Liverpool
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 252
1. Aged 18 to 65 years inclusive.
2. English speaking.
3. Prescribed clozapine for a minimum of three months.
4. Experiencing hypersalivation with a minimum score of 4 on the Drooling Rating Scale (DRS) and are either:
4.1. Currently not receiving treatment for CIH, OR
4.2. Receiving drug treatment for CIH and agreeable to a 48-hour washout period
5. Written and informed consent obtained from participant (with capacity and ability) and agreement of participant to comply with the requirements of the trial prior to study specific procedures.
Current participant exclusion criteria as of 07/03/2024:
1. Medical conditions that could influence hypersalivation (e.g., Parkinson’s Disease).
2. Neurological conditions that could affect cognitive functioning during the course of the study (e.g., unstable epilepsy).
3. History of an allergic reaction to hyoscine hydrobromide
4. History of an allergic reaction to glycopyrrolate.
5. Any of the following contra-indications to hyoscine hydrobromide or glycopyrrolate as stated in the British National Formulary:
5.1. Prostatic enlargement
5.2. Myasthenia gravis
5.3. Pyloric stenosis
5.4. Paralytic ileus
5.5. Glaucoma
5.6. Hepatic Impairment
6. Any of the following cautions to hyoscine hydrobromide or glycopyrrolate as stated in the British National Formulary:
6.1. Chronic heart failure
6.2. Stomach ulcer
6.3. Ulcerative colitis
6.4. Significant liver disease that in the opinion of the CI or PI is a contraindication
6.5. Down’s syndrome
6.6. Arrhythmia and/or history of myocardial infarction
6.7. Overactive thyroid gland.
6.8. Unstable angina
7. Current prescription for potassium chloride, digoxin, amantadine, levodopa, tricyclic antidepressants or monoamine oxidase inhibitors
8. Pregnant, trying to conceive or breastfeeding.
9. Sexually active heterosexual patients who are unable or unwilling to use contraception during the study (see section 10.4).
10. Participation in another drug study within the preceding 12 weeks (or within 5 half-lives of an IMP, whichever is longer) or use of other investigational drugs.
11. Active suicidal ideation as assessed within usual care.
12. Known sensitivity to any interventions or excipients.
13. Known history of intestinal obstruction.
14. Known history of urinary retention.
15. Severe renal impairment (eGFR <30 ml/min/1.73m2).
16. Known history of brain tumour or encephalitis.
Previous participant exclusion criteria:
1. Medical conditions that could influence hypersalivation (e.g., Parkinson’s Disease).
2. Neurological conditions that could affect cognitive functioning during the course of the study (e.g., unstable epilepsy).
3. History of an allergic reaction to hyoscine hydrobromide
4. History of an allergic reaction to glycopyrrolate.
5. Any of the following contra-indications to hyoscine hydrobromide or glycopyrrolate as stated in the British National Formulary:
5.1. Prostatic enlargement
5.2. Myasthenia gravis
5.3. Pyloric stenosis
5.4. Paralytic ileus
5.5. Glaucoma
5.6. Hepatic Impairment
6. Any of the following cautions to hyoscine hydrobromide or glycopyrrolate as stated in the British National Formulary:
6.1. Chronic heart failure
6.2. Stomach ulcer
6.3. Ulcerative colitis
6.4. Significant liver disease that in the opinion of the CI or PI is a contraindication
6.5. Down’s syndrome
6.6. Arrythmia and/or history of myocardial infarction
6.7. Overactive thyroid gland.
6.8. Unstable angina
7. Current prescription for a) potassium chloride, b) digoxin, c) amantadine, or d) levodopa.
8. Pregnant, trying to conceive or breastfeeding.
9. Patients who are unable or unwilling to use contraception during the study or abstain from sexual intercourse (see section 10.4).
10. Participation in another drug study within the preceding 12 weeks or use of other investigational drugs.
11. Active suicidal ideation as assessed within usual care.
12. Known sensitivity to any interventions or excipients.
13. Known history of intestinal obstruction.
14. Known history of urinary retention.
15. Severe renal i
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hypersalivation measured using the Drooling Rating Scale at Baseline, T 1, 2, 4, 6, 8, 12 and Optional T16, 20, 24
- Secondary Outcome Measures
Name Time Method