NCT00882856已完成不适用
Treating Clozapine-induced Sinustachycardia With Bisoprolol - a Double Blinded Placebo Controlled Cross Over Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Heart rate variability
研究概览
简要总结
Clozapine-induced sinustachycardia occurs in 25% of patients treated with clozapine and sustained sinustachycardia might be a risk factor for dilated cardiomyopathy. This double-blinded cross over placebo controlled study investigate whether 10 mg bisoprolol are efficient in treating clozapine-induced sinustachycardia measured as heart rate, heart rate variability, QTc and T-wave morphology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated with clozapine > 3 months and minimum 100 mg/day
- •Fixed dose 14 days before inclusion
- •Heart rate > 100 (ECG)
- •Pregnancy test negative
- •Clozapine-induced sinustachycardia documented by ECG or case record
- •Sexual abstinence or contraception
- •Informed consent
排除标准
- •Substance abuse
- •Physical diseases, contraindications for clozapine or bisoprolol
- •Asthma or chronic obstructive lung disease
- •Blood pressure < 100/60 or recent history of syncopes
- •QTc>500 ms, SA-block, AV- block II or III
- •Restrictions by Danish mental act
- •Allergic to clozapine or bisoprolol
研究组 & 干预措施
Placebo - wash out - bisoprolol
Active Comparator
Placebo - wash out - bisoprolol
干预措施: Placebo (Drug)
Bisoprolol-washout -placebo
Active Comparator
Bisoprolol - wash out - placebo
干预措施: Bisoprolol (Drug)
Bisoprolol-washout -placebo
Active Comparator
Bisoprolol - wash out - placebo
干预措施: Placebo (Drug)
Placebo - wash out - bisoprolol
Active Comparator
Placebo - wash out - bisoprolol
干预措施: Bisoprolol (Drug)
结局指标
主要结局
Heart rate variability
时间窗: Baseline, visit 1+2+3
次要结局
- QTc, T-wave morphology and other ECG markers(Baseline, visit 1+2+3)
- Salivation rate(Baseline, visit 1+2+3)
- Orthostatic blood pressure(Baseline, visit 1+2+3)
- WHO-QoL(Baseline, visit 1+2+3)
- Nocturnal Hypersalivation Rating Scale (NHRS).(Baseline, visit 1+2+3)
- Hamilton-Anxiety scale(Baseline, visit 1+2+3)
研究者
研究点 (1)
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