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

JRCT ID: jRCT1041210028

Registered date:03/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: schizophrenia
• Date of first enrollment: 03/06/2021
• Target sample size: 20
• Study type: Interventional

Intervention(s)

arm A:Apply sofpironium bromide gel for 6 weeks, followed by placebo 1 week later for 6 weeks.
arm B:Placebo is applied for 6 weeks, followed 1 week later by sofpironium bromide gel for 6 weeks.

Outcome(s)

• Primary Outcome: Saliva volume per minute(6 weeks later)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Amano Yuhei