None listed
Conditions
Brief summary
Clozapine is one of the most effective medications used for the treatment of schizophrenia. Up to 80% of patients treated with clozapine may complain of an increased secretion of saliva in the mouth (known as hypersalivation) as a result of being treated with clozapine. Hypersalivation may result in an overspill of saliva outside the mouth (known as drooling). Excessive production of saliva may disrupt sleep and speech, and cause aspiration pneumonia. Drooling is not pleasant and may damage the skin around your mouth. Atropine sulfate is one of the medications used most often in inpatient units in New South Wales-Australia to treat hypersalivation or drooling that is caused by clozapine. However, studies testing the effect of atropine are lacking. The aim from this study is to test the effect of atropine sulfate when administered under the tongue for the treatment of hypersalivation and/or drooling that is caused by clozapine. One sub-study to this study involves testing the chemical content of saliva by researchers in the ANZAC Research Institute at Concord Hospital. This research is designed by the mental health pharmacist Omar Mubaslat and overseen and supervised by consultant psychiatrist Professor Tim Lambert.
Interventions
The clinical trial aims to test the effect of sublingual atropine sulfate on clozapine induced hypersalivation and drooling. The effect will be compared to that of a placebo.
One dose composed of 2 drops of atropine sulfate 1% solution will be administered to participants at least one hour after dinner. This dose will be administered once only over one night by the nurse looking after the patient on the ward in the presence of the trial coordinator.
Prior to administering the study medication t
The clinical trial aims to test the effect of sublingual atropine sulfate on clozapine induced hypersalivation and drooling. The effect will be compared to that of a placebo. One dose composed of 2 drops of atropine sulfate 1% solution will be administered to participants at least one hour after dinner. This dose will be administered once only over one night by the nurse looking after the patient on the ward in the presence of the trial coordinator. Prior to administering the study medication to the participant, the nurse will administer two drops of the study medication in the plastic container to feel the pressure needed to squeeze the MINIM bottle.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Non pregnant and non-breast feeding adults 18 or more year old, 2. Treated with clozapine. 3. Hypersalivation or drooling started after starting clozapine, and the treating psychiatry physician believes it is most likely due to clozapine therapy. Hypersalivation or drooling is identified through either: Screening patients treated with clozapine for clozapine-induced hypersalivation or drooling as per the screening protocol. Or Examining patient for clozapine-induced hypersalivation or drooling after it is reported by the patient, healthcare team, or carers 4. Consents ,willingly, to participate in the study 5. The treating psychiatry physician chooses to enrol the patient in the study Note: all patients treated with clozapine must have schizophrenia
Exclusion criteria
1. Pregnant, breast feeding, or < 18 year old 2. Allergy to atropine or chloramphenicol. 3. Has any of the following disease: Anaemia, diarrhoea (suggestive of pseudomembranous colitis), neutropaenia (suggestive of bone marrow suppression), Narrow-Angle Glaucoma, Myasthenia Gravis, Prostatic Hypertrophy, bladder obstruction, Glucose-6-Phosphate Dehydrogenase (G-6-PD) Deficiency, GI obstructive disease such as ileus, or other medical illness that may be seriously adversely affected by atropine or quinine. 4. Treated with an anticoagulants or antiarrhythmics. 5. Have been given or started on any medication known to have an anticholinergic effect after the detection of hypersalivation or drooling
Outcome results
None listed