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临床试验/NL-OMON46083
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)

Academisch Medisch Centrum0 个研究点目标入组 156 人开始时间: 待定最近更新:
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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