Tranylcypromine Treatment of Bipolar Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- 29 Item Hamilton Rating Scale for Depression (HamD29)
研究概览
简要总结
This study seeks to investigate whether tranylcypromine (Parnate®) might be an effective treatment of bipolar depression. New treatments are needed, as there is little evidence that standard antidepressants are effective in treating this condition, and the two antipsychotic medications that have indications for bipolar depression can cause substantial side effects. This study will focus specifically on currently depressed outpatients having a bipolar history for whom at least one standard antidepressant medication was ineffective. Patients will be treated openly with tranylcypromine for 8-10 months, depending on treatment response.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of Bipolar I, II
- •Currently depressed (major depressive episode or depression NOS)
- •Physically healthy or physically stable (i.e.,No changes in medical interventions in past three months or likely for the next three months)
- •On stable and effective mood stabilizer or hypomania deemed sufficiently mild to not require a mood stabilizer.
- •Prior adequate trial on at least one antidepressant.
- •Able to follow a tyramine-free diet
- •Must speak English
排除标准
- •Current psychosis
- •past psychosis not occurring during an episode of mania or depression
- •prior nonremission to tranylcypromine 60 mg/d (or greater)
- •currently taking effective medication precluded while taking a Monoamine Oxidase Inhibitor (e.g., a psychostimulant or a serotonin re-uptake inhibitor)
- •current (last six months) drug or alcohol abuse or dependence
- •significant suicide risk
- •significant cardiovascular risk
研究组 & 干预措施
Tranylcypromine
Active, open-label tranylcypromine treatment
干预措施: Tranylcypromine (Drug)
结局指标
主要结局
29 Item Hamilton Rating Scale for Depression (HamD29)
时间窗: Hamilton 29 score at baseline (start date of medication) and week 16
29 Item Hamilton Rating Scale for Depression (HamD29) is the 29 item version of the most common depression rating scale. The scores represented here are the average scores at baseline and after 16 weeks of open label treatment. The scale is rated from 0-89 with higher scores representing a more depressed state.
次要结局
未报告次要终点