Antibodies to Digoxin for Bipolar Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- improvement
研究概览
简要总结
Subjects suffering from bipolar disorders treated with specific medications will give their informed concent and will receive intravenously only one dose of Digoxin antibodies (Fab). Their response to this therapy will be measured accordingly.Previous medications will be not changed A base line serum Endogenous Digitalis-like Compounds (DLC)levels will be measured using a specific laboratory technique and these compounds will be measured at 6 and 24 hours after Fab therapy.
Patients also will be followed using clinical and psychological tests
详细描述
Twenty subjects suffering from bipolar disorders treated with specific medications will give their informed concent and will included in the study. All will receive in an open study only one intravenously dose of Digoxin antibodies (Fab). Their response to this therapy will be measured accordingly.Previous medications will be not changed A base line serum Endogenous Digitalis-like Compounds (DLC)levels will be measured using a specific laboratory technique and these compounds will be measured at 6 and 24 hours after Fab therapy.
Patients also will be followed using clinical and psychological tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted patients suffering from Bipolar Disorder
- •abillity to give informed concent
排除标准
- •Allergy to Digoxin Antibodies
- •Renal and Liver function impairment
- •Liver Cirrhosis
- •Patients on Digoxin or Digitoxin
- •Patients receiving Aldactone therapy
- •Heart A-V Block
- •Hypo or Hyperkalemia on admission
- •Potential Suicidal Behaviour
研究组 & 干预措施
digibind
Injection of digibind and psychological tests
干预措施: Digibind (Fab) (Drug)
结局指标
主要结局
improvement
时间窗: 24 hours
次要结局
未报告次要终点