跳至主要内容
临床试验/NL-OMON20015
NL-OMON20015尚未招募不适用

Efficacy and feasibility of intranasal ketamine on acute suicidality, a multicenter double blind randomized placebo-controlled trial -pilot

niversity Medical Center Groningen (UMCG)0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
12

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

入选标准

  • Acute suicidality: suicidal thoughts and/or behaviour have increased within the last 24 hours.
  • BSSI score = 7
  • Subjects are in the age of 18-70

排除标准

  • Earlier participation in this study
  • Psychosis (as a primary diagnosis) (depression with psychotic features will not be an exclusion criterion per se).
  • Schizophrenia or another primary psychotic disorder
  • 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 current GHB-intoxication and a high blood alcohol concentration, and intoxications leading to medical unstable conditions). Use of GHB will be assessed by asking the participant, since urinary analysis is relatively unreliable, and waiting for results of the blood test will, given the acute nature of this study, be too time consuming.
  • A blood alcohol concentration (BAC) of > 0.05%
  • Clinically significant and unstable infectious, immunological, neurological cardiovascular, gastro-intestinal, pulmonary, renal, ophthalmological (glaucoma), hepatic, endocrine or haematological disorder, a myocardial infarction, micturition problems or a complex surgical problem that needs immediate attention.
  • Presence of any contra-indication for ketamine use, such as severe high blood pressure, a recent myocardial infarction or relevant cardiac problems, severe thyroid problems, severe liver problems, severe kidney problems, epilepsy and increased intracranial pressure.
  • A known hypersensitivity for ketamine
  • Concomitant use of a MAO-inhibitor
  • Severe nose congestion or nasal polyps
  • Pregnancy or giving breastfeeding
  • Women in the reproductive age using unreliable contraception
  • Being unable to answer the questionnaires
  • Legal incompetency with regard to participation in this study
  • No informed consent

研究者

发起方
niversity Medical Center Groningen (UMCG)

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