NL-OMON52646招募中2 期
Efficacy and feasibility of ketamine on acute suicidality, a multicenter double blind randomized placebo-controlled trial (Ketamine Trial for Acute suicidality, KETA) - Ketamine Trial for Acute suicidality (KETA)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
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 96 hours of the hypothetical administration of ketamine/midazolam.
- •A Beck Scale for Suicide Ideation (BSSI)-score of 7 or above
- •Subjects are in the age of 18-70
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. Concomitant use of a potent CYP3A4 inhibitor, such as clarithromycin,
- •erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil,
- •goldenseal and grapefruit.
- •12. Concomitant use of a potent CYP3A4 inducer such as phenytoin, rifampicin,
- •St. John*s Wort and glucocorticoids.
- •13. Severe nose congestion or nasal polyps.
- •14. Pregnancy or giving breastfeeding
- •15. Women of reproductive age, who are heterosexually active, using unreliable
- •contraception.
- •16. Being unable to answer the questionnaires
- •17. Legal incompetency with regard to participation in this study
- •18. No informed consent
研究者
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