Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide

Suicidal Ideation Clinical Trial

— PROTORISC  

Official title:

Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide - PROTORISC Pilote

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06430489
• Other study ID #: DR230123
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: January 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Tours
• Contact: ANAIS VANDEVELDE, MD, PHD
• Phone: +33247474747
• Email: anais.vandevelde[@]chu-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Emergency Psychiatric
• Nitrous Oxide
• Suicidal Ideation

Intervention

Drug:
• Nitrous oxide
inhaled nitrous oxide (1 hour at 50% concentration)
• Medical air
inhaled medical air (1 hour)

Locations

Country	Name	City	State
France	Psychiatric Emergencies	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	suicidal ideation severity	Suicidal ideation severity decrease (SSI)	At Hour 4
Secondary	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
Secondary	Suicidal ideation assessed by the SSI scale.		At Hour 24, at Hour 48, at Day 7 and at Month 1
Secondary	Suicidal ideation assessed by the Columbia Suicidal Risk Severity Scale (C-SSRS).		At Day 0 and Day 7
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Consumption of psychotropic medication for anxiolytic or sedative purposes.		At Hour 0 up to Hour 4