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Clinical Trials/IRCT20211110053031N1
IRCT20211110053031N1
Not yet recruiting
Phase 2

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

Shiraz University of Medical Sciences0 sites1 target enrollmentTBD

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Shiraz University of Medical Sciences
Enrollment
1
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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