An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-On, Open-Label Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 主要终点
- Score on a Mania Rating Scale
研究概览
简要总结
The investigators plan to to study an extended-release form of clonidine, which the investigators hope will be even better tolerated than the immediate-release form, as an antimanic agent. Subjects will receive an extended-release form of clonidine in addition to their usual medication regimen on the second day of this three-day study. Rating scales, a record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3 days. Any medication changes made by the attending psychiatrist and prns administered will be recorded throughout the study.
详细描述
Clonidine has been reported to be effective in a variety of hyperadrenergic states, including mania. It is generally well-tolerated and does not result in the severe adverse effects that are associated with many antipsychotics and mood stabilizers used in the treatment of mania, such as weight gain and akathisia. There is some suggestion that clonidine may be particularly effective in a subset of refractory cases and in patients who cannot tolerate antipsychotic medications or lithium. The investigators plan to to study an extended-release form of clonidine, which the investigators hope will be even better tolerated than the immediate-release form, as an antimanic agent. Subjects will receive an extended-release form of clonidine in addition to their usual medication regimen on the second day of this three-day study. Rating scales, a record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3 days. Any medication changes made by the attending psychiatrist and prns administered will be recorded throughout the study. The investigators believe that studying as few as 10 subjects will give the investigators a sense as to whether the addition of clonidine is helpful in reducing manic symptoms and if the rate of adverse effects is unacceptable.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meet SCID criteria for bipolar disorder, type I, Mania with YMRS > 15
- •No significant improvement in symptoms after three or more days of hospitalization
- •documented medical evaluation without identified acute or serious medical illness
- •negative pregnancy test in women of child-bearing age
排除标准
- •involuntary commitment or lack of capacity to provide informed consent
- •low blood pressure
研究组 & 干预措施
clonidine as an antimanic agent
Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.
干预措施: extended-release clonidine (Drug)
结局指标
主要结局
Score on a Mania Rating Scale
时间窗: 3 days
Mania rating scale to be performed each day of this 3 day study.
次要结局
未报告次要终点
