Emergency Psychiatric, Nitrous Oxide, Suicidal Ideation
Conditions
Brief summary
Suicide prevention is a major public health concern, with nearly 9,000 suicides and over 200,000 suicide attempts reported each year in France. Suicide attempts and suicidal ideation are among the most frequent reasons for emergency room visits and psychiatric hospitalizations. Although there is no approved pharmacological treatment for suicidal crises, some psychiatric treatments appear promising. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has shown promising results in reducing suicidal ideation. However, its use is limited due to its side effects. Nitrous oxide, another NMDA receptor inhibitor commonly used in anesthesia and pain management, has demonstrated rapid antidepressant effects and few side effects. Given its rapid and lasting effects, nitrous oxide could swiftly alleviate suicidal ideation.
Interventions
DRUGNitrous oxide
inhaled nitrous oxide (1 hour at 50% concentration)
DRUGMedical air
inhaled medical air (1 hour)
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Active suicidal ideations * Beck Scale for Suicidal Ideation score greater than or equal to 8 * French speaking * Patient admitted to psychiatric emergency department * Capable of wearing a facial mask * Having signed an informed consent * Affiliated with social security
Exclusion criteria
* Psychotic disorder, neurodegenerative disease, known substance use disorder (excluding caffeine or tobacco), substance intoxication, unstable somatic pathology * Pregnancy or breastfeeding * Contraindication to the use of nitrous oxide * Legal incapacity * Participation in another drug clinical trial * Patient subject to compulsory care measures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| suicidal ideation severity | At Hour 4 | Suicidal ideation severity decrease (SSI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Suicidal ideation assessed by the SSI scale. | At Hour 24, at Hour 48, at Day 7 and at Month 1 | — |
| Suicidal ideation assessed by the Columbia Suicidal Risk Severity Scale (C-SSRS). | At Day 0 and Day 7 | — |
| Depressive symptoms measured by hetero-assessment using the Montgomery-Asberg Depression Rating Scale (MADRS). | At Day 0 and Day 7 | The higher the total score, the greater the severity of depression |
| Depressive symptoms measured by the Patient Health Questionnaire PHQ-9 self-administered questionnaire. | At Day 0, At Hour 4, at Hour 24, at Hour 48 and at Day 7 | The higher the total score, the greater the severity of depression |
| suicidal ideation severity | At Hour 24, at Hour 48, at Day 7 and at Month 1 | Suicidal ideation severity decrease (SSI): The score ranges from 0 to 38. The higher the total score, the greater the severity of suicide ideation |
| Overall improvement measured by change in Clinical Global Impression - Improvement (CGI) scale score. | At Day 0 up to Hour 4, at Hour 24, at Hour 48 and at Day 7 | The higher the score, the more the clinical condition has worsened |
| Commitment to suicidal action in the month following inclusion | in the month following Day 0 | Number of suicide attempts and methods in the month following the intervention |
| Consumption of psychotropic medication for anxiolytic or sedative purposes. | At Hour 0 up to Hour 4 | — |
| Intensity of anxiety measured by the State and Trait Anxiety Inventory (STAI) scale. | At Day 0 up to Hour 4, at Hour 24, at Hour 48 and at Day 7 | The higher the total score, the greater the severity of anxiety |
Countries
France
Contacts
Primary ContactANAIS VANDEVELDE, MD, PHD
Backup ContactStellina AUGIS
Outcome results
None listed