Effectiveness of sofpironium bromaide gel for clozapine-induced hypersalivation in patients with treatment-ressistant schizophrenia:A double-blind comparative study (Effectiveness of ECCLOCKgel for clozapine-induced hypersalivation)

Phase 3

• Conditions: schizophrenia; schizophrenia,hypersalivation; D019967

• Registration Number: JPRN-jRCTs041210033
• Lead Sponsor: Amano Yuhei

Brief Summary

We suggest that sofpironium bromide gel is effective in treating clozapine-induced hypersalivation in patients with treatment-resistant schizophrenia.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-17
• Study Completion: 2021-12-16
• Results First Posted: 2023-01-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 16

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Saliva volume per minute(6 weeks later)

Secondary Outcome Measures

Name	Time	Method
Saliva volume per minute(2,4,6 weeks after)<br>Objective drooling rating scale(Drooling Severity and Frequency Scale),(Nocturnal Hypersalivation Rating Scale)<br> Subjective symptoms of drooling by VAS (Visual Analog Scale) <br>Dverse events