跳至主要内容
临床试验/NCT03065933
NCT03065933终止4 期

An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-On, Open-Label Study

Mclean Hospital0 个研究点目标入组 5 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth S. Liebson

PI

Mclean Hospital

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