EUCTR2015-004745-70-NL进行中（未招募）1 期
Efficacy of intranasal ketamine on acute suicidality, a double blind randomized placebo-controlled trial(Ketamine Trial Amsterdam, KETA) - Ketamine Trial Amsterdam, (KETA)
Academic Medical Center (AMC)0 个研究点目标入组 128 人开始时间: 2018年8月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Acute suicidality
- •A Beck Scale for Suicide Ideation (BSSI)-score of 7 or above
- •Subjects are in the age of 18-70
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •-Psychosis
- •-A diagnosis of schizophrenia or another psychotic disorder
- •-A history of PCP- or ketamine addiction
- •-Being under influence of GHB
- •-A blood alcohol concentration (BAC)of >0.05%
- •-A clinically significant and unstable 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 seligiline
- •-Severe nose congestion or nasal polyps
- •-Pregnancy or giving breastfeeding
- •-Women using unreliable contraception
- •-Being unable to answer the questionnaires
- •-Being unwilling or unable to provide informed consent
- •-Earlier participation in this study
研究者
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