Efficacy and feasibility of ketamine on acute suicidality, a multicenter double blind randomized placebo-controlled trial (Ketamine Trial for Acute suicidality, KETA)

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 112

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in suicidality scores on the BSSI between baseline and 180 minutes after<br /><br>75 mg intranasal ketamine administration compared to 4.0 mg intranasal<br /><br>midazolam (placebo).</p><br>

Secondary Outcome Measures