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

Phase 2

Withdrawn

Conditions: self-harm
suicidality
10042460

Registration Number: NL-OMON46083

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 156

Inclusion Criteria

Acute suicidality: suicidal thoughts and/or behaviour have increased within the last 24 hours.
A Beck Scale for Suicide Ideation (BSSI)-score of 7 or above
Subjects are in the age of 18-70

Exclusion Criteria

-Earlier participation in this study
-Psychosis
-A diagnosis of schizophrenia or another psychotic disorder
-A history of PCP- or ketamine addiction
-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)
-A blood alcohol concentration (BAC)of >0.05%
-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
-A known hypersensitivity for ketamine
-Concomitant use of a MAO-inhibitor
-Severe nose congestion or nasal polyps
-Pregnancy or giving breastfeeding
-Women using unreliable contraception
-Being unable to answer the questionnaires
-Legal incompetency
-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 3.8 mg intranasal<br /><br>midazolam (placebo).</p><br>

Secondary Outcome Measures