Clinical TrialSuicidalityPlaceboNitrous OxideNot yet recruiting

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

This Phase II interventional trial (n=30), will investigate the efficacy of nitrous oxide in alleviating suicidal ideation (SI).

Target Enrollment
30 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, parallel-group Phase II study in psychiatric emergency department patients with active suicidal ideation comparing a single 60-minute inhalation of 50% nitrous oxide versus medical air.

Primary aim is rapid reduction in suicidal ideation; outcomes include validated suicidal ideation scales, safety/tolerability and short-term clinical course with follow-up assessments.

Study Protocol

Preparation

sessions

Dosing

1 sessions
60 min each

Integration

sessions

Study Arms & Interventions

Medical air

inactive

Inhaled medical air for 60 minutes (placebo comparator).

Interventions

  • Placebo
    via Inhalation• single session• 1 doses total

    Inhaled medical air for 60 minutes (placebo comparator).

Nitrous oxide

experimental

Inhaled nitrous oxide 50% for 60 minutes (active).

Interventions

  • Nitrous Oxide
    via Inhalation• single session• 1 doses total

    50% nitrous oxide inhaled for 60 minutes.

Participants

Ages
18 – 50
Sexes
Male & Female

Inclusion 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

  • 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 Details

  • Status
    Not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment30 participants
  • Timeline
    Start: 2024-06-01
    End: 2026-01-31
  • Compounds
    PlaceboNitrous Oxide
  • Topic
    Suicidality

Locations

Psychiatric Emergencies — Tours, France

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