Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide

Phase 2Not Yet RecruitingNCT06430489

University Hospital, Tours30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Suicidal Ideation Emergency Psychiatric Nitrous Oxide

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

suicidal ideation severity

Suicidal ideation severity decrease (SSI)

Time frame: At Hour 4

Secondary Outcomes

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

Time frame: At Hour 24, at Hour 48, at Day 7 and at Month 1

Suicidal ideation assessed by the SSI scale.

Time frame: 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).

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

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

Time frame: in the month following Day 0

Consumption of psychotropic medication for anxiolytic or sedative purposes.

Time frame: At Hour 0 up to Hour 4