Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide

NCT06430489 | Not Yet Recruiting Phase 2

• 1 other identifier: DR230123
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation; Emergency Psychiatric; Nitrous Oxide

Outcome Measures

Primary Outcomes (1)

• suicidal ideation severity

  Suicidal ideation severity decrease (SSI)

  At Hour 4

Secondary Outcomes (9)

• suicidal ideation severity

  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

• 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

• 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

Study Arms (2)

Medical air administration

PLACEBO COMPARATOR

Drug: Medical air

Nitrous oxide administration

EXPERIMENTAL

Drug: Nitrous oxide

Interventions

Nitrous oxide DRUG

inhaled nitrous oxide (1 hour at 50% concentration)

Nitrous oxide administration

Medical air DRUG

inhaled medical air (1 hour)

Medical air administration

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Psychiatric Emergencies

Tours, 37044, France

Location

MeSH Terms

Conditions

Suicidal Ideation

Interventions

Nitrous Oxide; Air

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• ANAIS VANDEVELDE, MD, PHD

  CHRU de Tours

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ANAIS VANDEVELDE, MD, PHD

CONTACT

+33247474747; anais.vandevelde@chu-tours.fr

Stellina AUGIS

CONTACT

02.47.47.46.38; stellina.augis@chu-tours.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 28, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: June 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)