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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical air administration | Placebo Comparator |
| |
| Nitrous oxide administration | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrous oxide | Drug | inhaled nitrous oxide (1 hour at 50% concentration) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| suicidal ideation severity | Suicidal ideation severity decrease (SSI) | At Hour 4 |
| Measure | Description | Time Frame |
|---|---|---|
| suicidal ideation severity | Suicidal ideation severity decrease (SSI): The score ranges from 0 to 38. The higher the total score, the greater the severity of suicide ideation | At Hour 24, at Hour 48, at Day 7 and at Month 1 |
| Suicidal ideation assessed by the SSI scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ANAIS VANDEVELDE, MD, PHD | Contact | +33247474747 | anais.vandevelde@chu-tours.fr | |
| Stellina AUGIS | Contact | 02.47.47.46.38 | +33 | stellina.augis@chu-tours.fr |
| Name | Affiliation | Role |
|---|---|---|
| ANAIS VANDEVELDE, MD, PHD | CHRU de Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Emergencies | Tours | 37044 | France |
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| D000388 | Air |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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| Medical air |
| Drug |
inhaled medical air (1 hour) |
|
| 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). | The higher the total score, the greater the severity of depression | At Day 0 and Day 7 |
| Depressive symptoms measured by the "Patient Health Questionnaire" PHQ-9 self-administered questionnaire. | The higher the total score, the greater the severity of depression | At Day 0, At Hour 4, at Hour 24, at Hour 48 and at Day 7 |
| Intensity of anxiety measured by the "State and Trait Anxiety Inventory" (STAI) scale. | The higher the total score, the greater the severity of anxiety | At Day 0 up to Hour 4, at Hour 24, at Hour 48 and at Day 7 |
| Overall improvement measured by change in Clinical Global Impression - Improvement (CGI) scale score. | The higher the score, the more the clinical condition has worsened | At Day 0 up to Hour 4, at Hour 24, at Hour 48 and at Day 7 |
| Commitment to suicidal action in the month following inclusion | Number of suicide attempts and methods in the month following the intervention | in the month following Day 0 |
| Consumption of psychotropic medication for anxiolytic or sedative purposes. | At Hour 0 up to Hour 4 |
| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |