Acute Suicidality
Conditions
Interventions
intranasal ketamine
Sponsors
University Medical Center Groningen (UMCG)
Eligibility
Inclusion criteria
Inclusion criteria: Acute suicidality: suicidal thoughts and/or behaviour have increased within the last 24 hours. BSSI score = 7 Subjects are in the age of 18-70
Exclusion criteria
Exclusion criteria: Earlier participation in this study Psychosis (as a primary diagnosis) (depression with psychotic features will not be an exclusion criterion per se). Schizophrenia or another primary psychotic disorder 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 current GHB-intoxication and a high blood alcohol concentration, and intoxications leading to medical unstable conditions). Use of GHB will be assessed by asking the participant, since urinary analysis is relatively unreliable, and waiting for results of the blood test will, given the acute nature of this study, be too time consuming. A blood alcohol concentration (BAC) of > 0.05% 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. 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. A known hypersensitivity for ketamine Concomitant use of a MAO-inhibitor Severe nose congestion or nasal polyps Pregnancy or giving breastfeeding Women in the reproductive age using unreliable contraception Being unable to answer the questionnaires Legal incompetency with regard to participation in this study 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Suicidality from baseline to 60 minutes, 180 minutes, 1, 3 and 7 days after one intranasal ketamine administration as measured with: a. Beck Scale for Suicide Ideation (BSSI) (Dutch version) b. Suicidality item on the Montgomery Asberg Depression Rating Scale. (MADRS) (Dutch version). 2. Actual number of suicides and suicidal acts at 60 and 180 minutes, 1, 3 and 7 days and after ketamine administration. 3. Depressive symptoms as measured with the MADRS from baseline to 60 and 180 minutes, 1, 3 and 7 days and after one intranasal ketamine administration compared to placebo. 4. Clinical severity and improvement as measured with the CGI. 5. Psychotomimetic symptoms, as measured with the SAFTEE (Dutch version) and the CADSS (Dutch version) from baseline to 60 and 180 minutes. 6. 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 (61). Furthermore, at baseline one 9ml EDTA sample will be taken in order to study genetics. (See table 1) 7. Plasma ketamine concentration at 180 minutes. 8. Structural MRI, functional MRI (fMRI), diffusion tensor imaging (DTI), H-MRS-analysis of glutamate in hippocampus and prefrontal cortex, at one day after ketamine administration. 9. A responder/non responder analysis. (Response is defined as a 50% reduction in BSSI-score) for the total study period. 10. Correlation patterns for the total study period between changes in BSSI- and MADRS-scores. 11. Correlation patterns for the total study period between sex and changes in BSSI scores. | — |
Contacts
Public ContactJurriaan Strous
University Medical Center Groningen
Outcome results
None listed