Prazosin as an Antimanic Agent in Severe Mania or Mixed Episodes: a Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Young Mania Rating Scale (YMRS)
研究概览
简要总结
Mania has been considered to be, in part, a hyperadrenergic state. One focus of treatment of mania involves directly targeting this hyperexcitable state by reducing arousal with antiadrenergic agents. This can be achieved by decreasing norepinephrine release by stimulating presynaptic inhibitory receptors. Prazosin, FDA approved for the treatment of high blood pressure works in part by blocking postsynaptic alpha-adrenergic receptors. Prazosin has been found to be clinically useful for the treatment of Post Traumatic Stress Disorder. It is reasonable, therefore, to anticipate that prazosin might be helpful in the treatment of mania.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Age 18-60
- •Primary diagnosis of bipolar disorder with severe mania or mixed episode
- •YMRS score of > 20
- •Documented medical evaluation without acute or serious medical illness
- •Negative pregnancy test
- •Healthy functioning liver
排除标准
- •Lack of capacity to provide informed consent
- •Involuntary commitment
- •Low blood pressure
- •History of adverse reaction or allergy to prazosin or other quinazolines
- •Informed consent not given or retracted during study
- •History of narcolepsy
- •Unstable or acute medical illness
研究组 & 干预措施
prazosin
Add prazosin to usual medications and monitor manic symptoms and for adverse effects
干预措施: Addition of prazosin to usual care (add-on study) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Young Mania Rating Scale (YMRS)
时间窗: 10 days
次要结局
- Mania Acute Changes Scale (MACS)(10 days)