Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide (PROTORISC)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Suicidal Ideation; Emergency Psychiatric; Nitrous Oxide
• Intervention / Treatment: Drug: Medical air; Drug: Nitrous oxide

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Stellina AUGIS; Phone Number: +33 02.47.47.46.38; Email: stellina.augis@chu-tours.fr
• Study Contact Backup: Name: ANAIS VANDEVELDE, MD, PHD; Phone Number: +33247474747; Email: anais.vandevelde@chu-tours.fr

Study Locations

• France
  • Tours, France, 37044
    • Psychiatric Emergencies
    • Contact: ANAÏS VANDEVELDE, MD PhD; Phone Number: +33 02.47.47.95.08; Email: anais.vandevelde@chu-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Medical air administration	Drug: Medical air; inhaled medical air (1 hour)
Experimental: Nitrous oxide administration	Drug: Nitrous oxide; inhaled nitrous oxide (1 hour at 50% concentration)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
suicidal ideation severity	Suicidal ideation severity decrease (SSI)	At Hour 4

Secondary Outcome Measures

Outcome Measure	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.		At Hour 24, at Hour 48, at Day 7 and at Month 1
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: ANAIS VANDEVELDE, MD, PHD, CHRU de Tours

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease Attributes; Self-Injurious Behavior; Suicide; Emergencies; Suicidal Ideation; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: DR230123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No