Evaluation and comparison of efficacy of atropine eye drops and ipratropium bromide oral spray and amitriptyline tablet in the management of clozapine-induced sialorrhea

Phase 2

Conditions: Clozapine-resistant schizophrenic patients with clozapine-induced sialorrhea.
Schizophrenia

Registration Number: IRCT20211110053031N1

Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 1

Inclusion Criteria

Patients aged 18 to 65 years with a diagnosis of schizophrenia according to the DSM-V criteria
Patients should be receiving clozapine for at least 30 days
Patients should have a minimum score of 2 on the TNHS scale for sialorrhea

Exclusion Criteria

Development of allergies or history of allergies to amitriptyline, atropine and ipratropium bromide
Has an underlying disease such as Parkinson's or cerebral palsy that causes sialorrhea
The patient has problems and comorbidities such as untreated constipation or urinary retention or bladder obstruction
Concomitant use of drugs such as tricyclic antidepressants and atropine and ipratropium bromide and other anticholinergic drugs
Breastfeeding and pregnancy
History of diseases such as myasthenia gravis, seizures, cardiac arrhythmias, glaucoma, pyloric obstruction, prostate hypertrophy, renal failure, severe autonomic dysfunction, mental retardation, and paralytic paralysis

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness score of amitriptyline in reducing clozapine-induced sialorrhea according to TNHS (Toronto Nocturnal Hypersalivation scale). Timepoint: At the beginning of the study, then daily for 7 days, then on days 14, 21 and 28. Method of measurement: Toronto Nocturnal Hypersalivation scale.;The effectiveness of atropine eye drops in reducing clozapine-induced sialorrhea according to the TNHS Toronto Nocturnal Hypersalivation Scale. Timepoint: At the beginning of the study, then daily for 7 days, then on days 14, 21 and 28. Method of measurement: Toronto Nocturnal Hypersalivation scale.;Effective score of ipratropium bromide nasal spray in reducing clozapine-induced sialorrhea according to TNHS (Toronto Nocturnal Hypersalivation scale). Timepoint: At the beginning of the study, then daily for 7 days, then on days 14, 21 and 28. Method of measurement: TNHS (Toronto Nocturnal Hypersalivation scale).

Secondary Outcome Measures