JPRN-jRCTs041210033已完成3 期
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)
Amano Yuhei0 个研究点目标入组 16 人开始时间: 2021年6月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
We suggest that sofpironium bromide gel is effective in treating clozapine-induced hypersalivation in patients with treatment-resistant schizophrenia.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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