MedPath

Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide

Phase 2
Not yet recruiting
Conditions
Emergency Psychiatric
Suicidal Ideation
Nitrous Oxide
Interventions
Registration Number
NCT06430489
Lead Sponsor
University Hospital, Tours
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
30
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Medical air administrationMedical air-
Nitrous oxide administrationNitrous oxide-
Primary Outcome Measures
NameTimeMethod
suicidal ideation severityAt Hour 4

Suicidal ideation severity decrease (SSI)

Secondary Outcome Measures
NameTimeMethod
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

The higher the total score, the greater the severity of anxiety

Commitment to suicidal action in the month following inclusionin the month following Day 0

Number of suicide attempts and methods in the month following the intervention

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 severityAt Hour 24, at Hour 48, at Day 7 and at Month 1

Suicidal ideation severity decrease (SSI): The score ranges from 0 to 38. The higher the total score, the greater the severity of suicide ideation

Depressive symptoms measured by hetero-assessment using the "Montgomery-Asberg Depression Rating Scale" (MADRS).At Day 0 and Day 7

The higher the total score, the greater the severity of depression

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

The higher the total score, the greater the severity of depression

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

The higher the score, the more the clinical condition has worsened

Consumption of psychotropic medication for anxiolytic or sedative purposes.At Hour 0 up to Hour 4

Trial Locations

Locations (1)

Psychiatric Emergencies

🇫🇷

Tours, France

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