EUCTR2020-002905-24-NL进行中（未招募）1 期
Efficacy and feasibility of intranasal ketamine on acute suicidality, a double blindrandomized placebo-controlled trial(Ketamine Trial for Acute suicidalty, KETA) - Ketamine Trial for Acute suicidality (KETA)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 112
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 18-7
- •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 112
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Earlier participation in this study
- •2. Psychosis (as a primary diagnosis) (depression with psychotic features will not be an exclusion criterion per se).
- •3. A diagnosis of schizophrenia or another primary psychotic disorder.
- •4. A history of PCP- or ketamine addiction.
- •5. 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).
- •6. A blood alcohol concentration (BAC)of >0.05%
- •7. 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.
- •8. 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.
- •9. A known hypersensitivity for ketamine.
- •10. Concomitant use of a MAO-inhibitor.
- •11. Severe nose congestion or nasal polyps.
- •12. Pregnancy or giving breastfeeding 13. Women of reproductive age using unreliable contraception.
- •14. Being unable to answer the questionnaires
- •15. Legal incompetency with regard to participation in this study
- •16. No informed consent
研究者
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