schizophrenia schizophrenia,hypersalivation
Conditions
Sponsors
Amano Yuhei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed as schizophrenia according to DSM-5 diagnostic criteria 2. Patients who have been continuously taking clozapine for at least 8 weeks prior to enrollment and have moderate or excessive drooling (5 points or more on the Drooling Severity and Frequency Scale) 3. Inpatients and outpatients 4. Patients who can provide written consent for participation in this study from themselves or their guardians
Exclusion criteria
Exclusion criteria: 1.Patients with obvious deterioration of psychiatric symptoms within the past 4 weeks 2.Patients whose general condition has deteriorated within the past 4 weeks, and whose participation in the study is judged to be inappropriate. 3.Patients with closed-angle glaucoma, dysuria due to prostatic hypertrophy, and patients with a history of hypersensitivity to the ingredients of Sofpironium bromide gel 4.Patients taking oral anticholinergic medication 5.Patients who are judged by the physician to be inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Saliva volume per minute(6 weeks later) | — |
Secondary
| Measure | Time frame |
|---|---|
| Saliva volume per minute(2,4,6 weeks after) Objective drooling rating scale(Drooling Severity and Frequency Scale),(Nocturnal Hypersalivation Rating Scale) Subjective symptoms of drooling by VAS (Visual Analog Scale) Dverse events | — |
Contacts
Public ContactJun Mazda
Anzunokai Kakamigahara Hospital
Outcome results
None listed