NCT01046851Unknown3 期
Phase 3 Study of the Effects of Nopan as add-on Treatment to Antidepressants in Treating Depression and Suicidality
Prof. Yoram Yovell3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Reduction in Suicidality as expressed by the score on the BSI
研究概览
简要总结
Anecdotal evidence and several clinical studies found the mixed opioid agonist-antagonist Nopan to be an effective antidepressant with a rapid onset of action. It is therefore hypothesized that Nopan may be a novel and quick-acting treatment for acute suicidality. Depression, suicidality, and overall functioning will be assessed before, during and after a four-week Nopan/placebo trial. It is hypothesized that subjects who receive the active drug will show rapid improvements in objective and subjective measures of these variables.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •suicidal behavior or ideation (BSI>6)
排除标准
- •ECT history within the last month
- •psychotic features within the last 3 months
- •history of schizophrenia, substance or alcohol abuse within the last two years
- •benzodiazepine dependence within the last two years
- •any significant systemic illness or unstable medical condition which does not permit inclusion, according to the research physician
- •pregnant women
- •patients who currently suffer from severe impairment or severe dysfunction of liver, kidney, adrenal, gall, closed brain injury, urinary retention or respiratory system.
研究组 & 干预措施
Nopan
Active Comparator
干预措施: Nopan (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in Suicidality as expressed by the score on the BSI
时间窗: 4 weeks
次要结局
- Reduction in depression as measured by the BDI(4 weeks)
研究者
Prof. Yoram Yovell
MD, PhD
University of Haifa
研究点 (3)
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