Clinical trial NCT06430489: Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide
Official title: Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide - PROTORISC Pilote
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Suicidal Ideation
Emergency Psychiatric
Nitrous Oxide
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: suicidal ideation severity
timeFrame: At Hour 4
Secondary outcomes:
measure: suicidal ideation severity
timeFrame: At Hour 24, at Hour 48, at Day 7 and at Month 1
measure: Suicidal ideation assessed by the SSI scale.
timeFrame: At Hour 24, at Hour 48, at Day 7 and at Month 1
measure: Suicidal ideation assessed by the Columbia Suicidal Risk Severity Scale (C-SSRS).
timeFrame: At Day 0 and Day 7
measure: Depressive symptoms measured by hetero-assessment using the "Montgomery-Asberg Depression Rating Scale" (MADRS).
timeFrame: At Day 0 and Day 7
measure: Depressive symptoms measured by the "Patient Health Questionnaire" PHQ-9 self-administered questionnaire.
timeFrame: At Day 0, At Hour 4, at Hour 24, at Hour 48 and at Day 7
measure: Intensity of anxiety measured by the "State and Trait Anxiety Inventory" (STAI) scale.
timeFrame: At Day 0 up to Hour 4, at Hour 24, at Hour 48 and at Day 7
measure: Overall improvement measured by change in Clinical Global Impression - Improvement (CGI) scale score.
timeFrame: At Day 0 up to Hour 4, at Hour 24, at Hour 48 and at Day 7
measure: Commitment to suicidal action in the month following inclusion
timeFrame: in the month following Day 0
measure: Consumption of psychotropic medication for anxiolytic or sedative purposes.
timeFrame: At Hour 0 up to Hour 4
Other outcomes:
Locations:
city: Tours
country: France
facility: Psychiatric Emergencies
Study officials:
affiliation: CHRU de Tours
name: ANAIS VANDEVELDE, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: