(acute) suicidality, depression, personality disorders, substance use disorder. (acute) suïcidaliteit, depressie, persoonlijkheidsstoornissen, middelenmisbruik
Conditions
Interventions
-ketamine nasal spray 75 mg
-midazolam nasal spray 3,8 mg (active placebo)
Sponsors
University Medical Center Amsterdam, location AMC
Eligibility
Inclusion criteria
Inclusion criteria: -Acute suicidality: suicidal thoughts and/or behaviour have increased within the last 24 hours. -score on the Beck Scale for Suicide Ideation (BSSI) > or = 7
Exclusion criteria
Exclusion criteria: -Earlier participation in this study -Psychosis -Schizophrenia or another psychotic disorder -History of PCP- or ketamine addiction -Being under the influence of GHB (Substance abuse in the (recent) history is not an exclusion crtierion per se (with the exception of GHB and high blood alcohol concentration, and intoxications leading to medical unstable conditions) Clinically significant and unstable infectious, immunological, neurological cardiovascular, gastro-intestinal, pulmonary, renal, ophthalmological (glaucoma), hepatic, endocrine or haematological disorder, a myocardial infarction, micturition 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 Beck Scale for Suicidal Ideation (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, 1, 3 and 7 days and 6 and 12 months after one intranasal ketamine administration as measured with: a. Beck Scale for Suicide Ideation (BSSI) b. Suicidality item on the Montgomery Asberg Depression Rating Scale. (MADRS). 2. Actual number of suicides and suicidal acts in 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 and 180 minutes, 1, 3 and 7 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 and 180 minutes. 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 one directly into a serum gel tube. At 180 minutes also three blood samples will be taken to measure the BDNF concentration. Two in an EDTA tube and one into a serum gel tube. Furthermore, at baseline one 9ml EDTA sample will be taken in order to study genetics. 6. Plasma ketamine concentration at 180 minutes. 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. Correlation patterns for the total study period between changes in BSSI- and MADRS-scores 10. Correlation patterns for the total study period between sex and changes i | — |
Contacts
Public ContactD. Denys
PO Box 75867
Outcome results
None listed