Efficacy of ketamine nose-spray on acute suicidal thoughts and behaviou

Phase 1

• Conditions: Acute suicidality, which is a rapid increase in suicidal ideation orbehaviour from the patient's 'baseline' in the last 24 hours.; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-002905-24-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-10
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

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

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. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified