Clozapine-induced Hypersalivation - Feasibility Trial

• Status: Completed
• Trial end date: 2018-02-23
• Target enrollment: 0
• Participant gender: All

Summary

A randomised placebo-controlled feasibility study of glycopyrrolate and hyoscine in the treatment of clozapine-induced hypersalivation to assess recruitment and retention rates in a multi-centre trial.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mersey Care NHS Trust
• Collaborators: Lancashire Care NHS Foundation Trust; Manchester Mental Health & Social Care Trust; University of Central Lancashire; University of Manchester
• Treatments: Bromides; Butylscopolammonium Bromide; Clozapine; Glycopyrrolate; Scopolamine; Scopolamine Hydrobromide

Criteria

Inclusion Criteria:

1. Prescribed clozapine for a minimum of three months.

2. Is experiencing hypersalivation (minimum score of 4 on the Drooling Rating Scale).

3. Aged between 18 and 65 years and English speaking.

4. Is capable of understanding the information given and provides informed consent prior to study specific procedures.

Exclusion Criteria:

1. Medical conditions that could influence hypersalivation (e.g. idiopathic 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 or glycopyrrolate.

4. Any of the following contra-indications to hyoscine or glycopyrrolate as stated in the British National Formulary: prostatic enlargement, myasthenia gravis, pyloric stenosis, paralytic ileus, toxic megacolon.

5. Any of the following cautions to hyoscine or glycopyrrolate as stated in the British National Formulary e.g. closed angle glaucoma, chronic heart failure, chronic lung disease, untreated stomach ulcer, ulcerative colitis, significant liver problems, significant kidney disease, Downs Syndrome, persistent untreated tachycardia, overactive thyroid gland.

6. Current prescription for potassium chloride, digoxin, cimetidine, indacaterol, amantadine, atenolol, levodopa or medications that, in the view of the trial pharmacist, have a significant anticholinergic profile.

7. A woman of childbearing potential who has tested negative for pregnancy, unable or unwilling to use contraception during the study.

8. Participation in another therapeutic study within the preceding 12 weeks or use of other investigational drugs or agents.

9. Active suicidal ideation.

10. Lack of capacity to provide informed consent. -