self-harm suicidality
Conditions
Interventions
Subjects will be randomly allocated to either 75 mg of i.n. ketamine or the
active placebo midazolam (3.8mg i.n.). The patients will be treated on the
emergency ward of the general hospital of the A
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in suicidality scores on the BSSI between baseline and 180 minutes after 75 mg intranasal ketamine administration compared to 3.8 mg intranasal midazolam (placebo). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Suicidality from baseline to 60 minutes, 180 minutes, one day, three days and one week after one intranasal ketamine administration compared to placebo, as measured with: a. Beck Scale for Suicide Ideation (BSSI) b. Sheehan Suicidality Tracking Scale (SSTS) c. Suicidality item on the Montgomery Asberg Depression Rating Scale. (MADRS). 2. Actual number of suicides and suicidal at 60 and 180 minutes, 1, 3 and 7 days and 6 and 12 months after ketamine/midazolam administration. 3. Depressive symptoms as measured with the MADRS from baseline to 60 minutes and 180 minutes, one, three and seven days and 6 and 12 months after one intranasal ketamine administration compared to placebo. 4. Psychotomimetic symptoms, as measured with the Brief Psychiatric Rating Scale - Positive Subscale (BPRS) from baseline to 60 minutes and 180 minutes. 5. 5. Change in BDNF concentration, genetics and other biomarkers, and the correlation pattern between change in BDNF concentration and suicidality. Three blood samples will be taken by venepuncture at baseline: two samples into a vacuum tube containing ethylene diamine tetra-acetic acid (EDTA) that will be transferred into a heparinised tube, and onedirectly into a serum gel tube. At 180 minutes also three blood samples will be taken to measure, among others, the BDNF concentration. Two in an EDTA tube and one into a serum gel tube (57). Furthermore, at baseline one 8ml EDTA sample will be taken in order to study genetics. 6. Plasma ketamine concentration at 180 minutes after ketamine/midazolam administration 7. Structural MRI, functional MRI (fMRI), diffusion tensor imaging (DTI), H-MRS-analysis of glutamate in hippocampus and prefrontal cortex. Subjects that were administered ketamine will be compared to subjects that were administered midazolam, at one day after administration. 8. A responder/non responder analysis. (Response is defined as a 50% reduction in BSSI-score) for the total study period. 9. Correl | — |
Countries
Netherlands
Outcome results
None listed