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

R

Regional University Hospital Center (CHRU)

Status and phase

Not yet enrolling
Phase 2

Conditions

Suicidal Ideation
Emergency Psychiatric
Nitrous Oxide

Treatments

Drug: Medical air
Drug: Nitrous oxide

Study type

Interventional

Funder types

Other

Identifiers

NCT06430489
DR230123

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups, including a placebo group

Medical air administration
Placebo Comparator group
Treatment:
Drug: Medical air
Nitrous oxide administration
Experimental group
Treatment:
Drug: Nitrous oxide

Trial contacts and locations

1

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Central trial contact

Stellina AUGIS; ANAIS VANDEVELDE, MD, PHD

Data sourced from clinicaltrials.gov

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