NL-OMON46083撤回2 期
Efficacy of ketamine on acute suicidality, a multicenter double blind randomized placebo-controlled trial (Ketamine Trial Amsterdam, KETA) - Ketamine Trial Amsterdam (KETA)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •Acute suicidality: suicidal thoughts and/or behaviour have increased within the last 24 hours.
- •A Beck Scale for Suicide Ideation (BSSI)-score of 7 or above
- •Subjects are in the age of 18-70
排除标准
- •-Earlier participation in this study
- •-Psychosis
- •-A diagnosis of schizophrenia or another psychotic disorder
- •-A history of PCP- or ketamine addiction
- •-Being under influence of GHB (Substance abuse in the (recent) history is not an exclusion criterion per se (with the exception of GHB and a high blood alcohol concentration, and intoxications leading to medical unstable conditions)
- •-A blood alcohol concentration (BAC)of >0.05%
- •-A clinically significant and unstable infectious, immunological, cardiovascular, gastro-intestinal, pulmonal, renal, hepatic, endocrine or haematological disorder, a myocardial infarction, miction problems or a complex surgical problem that needs immediate attention
- •-A known hypersensitivity for ketamine
- •-Concomitant use of a MAO-inhibitor
- •-Severe nose congestion or nasal polyps
- •-Pregnancy or giving breastfeeding
- •-Women using unreliable contraception
- •-Being unable to answer the questionnaires
- •-Legal incompetency
- •-No informed consent
研究者
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