The effect of atropine sulfate 1% administered under the tongue on excessive saliva secretion and drooling caused by clozapine in patients with schizophrenia.

Phase 1

Completed

• Conditions: Clozapine-Induced Hypersalivation; Clozapine-Induced Drooling; Schizophrenia; Mental Health - Schizophrenia; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12618000051246
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-16
• Study Completion: 2019-02-28
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified