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

Phase 1

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

Registration Number: EUCTR2015-004745-70-NL

Lead Sponsor: Academic Medical Center (AMC)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 128

Inclusion Criteria

Acute suicidality
A Beck Scale for Suicide Ideation (BSSI)-score of 7 or above
Subjects are in the age of 18-70

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 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

-Psychosis
-A diagnosis of schizophrenia or another psychotic disorder
-A history of PCP- or ketamine addiction
-Being under influence of GHB
-A blood alcohol concentration (BAC)of >0.05%
-A clinically significant and unstable 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 seligiline
-Severe nose congestion or nasal polyps
-Pregnancy or giving breastfeeding
-Women using unreliable contraception
-Being unable to answer the questionnaires
-Being unwilling or unable to provide informed consent
-Earlier participation in this study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary Objective<br>To investigate the anti-suicidal effects of a single dose of intranasal ketamine in acutely suicidal subjects.<br>;Secondary Objective: to assess<br>- the safety, <br>-the antidepressant effects, <br>-time-course of the effects<br>-find neurobiological markers that predict and are associated with the response to ketamine using <br>ohippocampal magnetic resonance spectroscopy (MRS)<br>ostructural connectivity using diffusion tensor imaging (DTI)<br>ofunctional connectivity using magnetic resonance imaging (fMRI)<br>oBlood samples<br>;Primary end point(s): Change in suicidality scores on the BSSI between baseline and 180 minutes after 50 mg intranasal ketamine administration compared to 4.5 mg intranasal midazolam (placebo).;Timepoint(s) of evaluation of this end point: 180 minutes

Secondary Outcome Measures