Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide - PROTORISC Pilote
Overview
- Phase
- Phase 2
- Intervention
- Medical air
- Conditions
- Suicidal Ideation
- Sponsor
- University Hospital, Tours
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- suicidal ideation severity
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Medical air administration
Intervention: Medical air
Nitrous oxide administration
Intervention: Nitrous oxide
Outcomes
Primary Outcomes
suicidal ideation severity
Time Frame: At Hour 4
Suicidal ideation severity decrease (SSI)
Secondary Outcomes
- 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)
- suicidal ideation severity(At Hour 24, at Hour 48, at Day 7 and at Month 1)
- Depressive symptoms measured by hetero-assessment using the "Montgomery-Asberg Depression Rating Scale" (MADRS).(At Day 0 and Day 7)
- 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)
- 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)
- 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)
- Commitment to suicidal action in the month following inclusion(in the month following Day 0)