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

Evaluation and comparison of efficacy of atropine eye drops and ipratropium bromide oral spray and amitriptyline tablet in the management of clozapine-induced sialorrhea in patients with refractory schizophrenia using the TNHS(Toronto Nocturnal in the management of clozapine-induced sialorrhea in patients with refractory schizophrenia using the TNHS(Toronto Nocturnal Hypersalivation) scale Hypersalivation) scale

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211110053031N1
Enrollment
1
Registered
2022-06-14
Start date
2022-07-24
Completion date
Unknown
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention 1: Intervention group: In this group, patients are supposed to receive amitriptyline tablets from Iran Daroo Company at a dose of 25 mg first, and if the clozapine-induced sialorrhea comp

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactIman Karimzadeh

Shiraz University of Medical Sciences

karimzadehiman@yahoo.com+98 71 3242 4127

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026