Study on Reducing Suicidal Thoughts in Emergency Patients Using Nitrous Oxide and Oxygen Therapy

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What is this study about?

This clinical trial is focused on the treatment of suicidal ideation, which refers to having thoughts about or an unusual preoccupation with suicide. The study will use a treatment involving a mixture of two gases: nitrous oxide and oxygen, known as KALINOX 50%/50%. This mixture is a type of medicinal gas that is inhaled. Another medicinal gas, Medical Air, which contains nitrogen and oxygen, will also be used in the study.

The purpose of the study is to evaluate whether inhaling the nitrous oxide and oxygen mixture can reduce suicidal thoughts. Participants will inhale the gas mixture for one hour while they are in the emergency department. The study will monitor the intensity of suicidal thoughts four hours after the inhalation. The study will also assess the participants’ symptoms over a period of time, including at 24 hours, 48 hours, one week, and one month after the initial treatment.

Throughout the study, various assessments will be conducted to measure changes in suicidal thoughts, depressive symptoms, and anxiety levels. These assessments will help determine the overall improvement in the participants’ condition. The study aims to provide insights into the potential benefits of using this gas mixture as a treatment for individuals experiencing suicidal thoughts.

1 initial assessment

Upon arrival at the emergency department, a psychiatric evaluation is conducted to assess the presence of active suicidal thoughts.

The Beck Suicidal Ideation Scale (SSI) is used to measure the severity of suicidal thoughts. A score of 8 or higher is required for participation.

2 informed consent

The patient is provided with detailed information about the study and must sign an informed consent form to participate.

3 treatment administration

The patient receives an inhalation treatment consisting of a 50% nitrous oxide and 50% oxygen mixture, known as KALINOX, for a duration of one hour.

This treatment is administered in the emergency department.

4 initial evaluation post-treatment

Four hours after the inhalation treatment, the intensity and severity of suicidal thoughts are reassessed using the SSI scale.

Additional assessments include the Columbia Suicide Severity Rating Scale (C-SSRS) and the Montgomery-Asberg Depression Rating Scale (MADRS).

5 follow-up evaluations

Further evaluations are conducted at 24 hours, 48 hours, 7 days, and 30 days post-treatment.

These evaluations include the SSI, C-SSRS, MADRS, Patient Health Questionnaire (PHQ-9), and the State and Trait Anxiety Inventory (STAI).

The Clinical Global Impression – Improvement (CGI) scale is used to measure overall improvement.

6 monitoring and final assessment

The patient is monitored for any suicidal actions within the month following inclusion in the study.

The use of any anxiety or sedative medications is recorded between the initial treatment and four hours post-treatment.

Who Can Join the Study?

  • Be between 18 and 50 years old. This age limit is set to reduce the chance of other health issues and minor memory problems that are more common in older people.
  • Have active thoughts of suicide during a mental health evaluation in the emergency room.
  • Have a score of 8 or higher on the Beck Suicidal Ideation Scale, which is a tool used to measure how strong someone’s thoughts of suicide are.
  • Speak French.
  • Be admitted to the psychiatric emergency department at the CHRU of Tours.
  • Be able to wear a face mask.
  • Have signed the informed consent form, which means you agree to participate in the study after being told all the details.
  • Be affiliated with social security, which means you are part of a system that provides health coverage.

Who Cannot Join the Study?

Where you can join this trial?

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Other Sites

Site Name City Country Status
Cxhbbn Hffqerjeeov Rzcmuutf Uywdulcmbqjnz Dw Teaab Tours France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.05.2024

Trial locations

Protoxyde d’Azote: This medication, also known as nitrous oxide, is used in this trial to help reduce suicidal thoughts. It is inhaled as a gas mixture with oxygen for one hour. The goal is to see if it can quickly decrease suicidal thoughts in patients who are in emergency situations.

Investigated diseases:

Suicidal Ideation – Suicidal ideation refers to having thoughts about or an unusual preoccupation with suicide. It can range from fleeting thoughts to detailed planning. The condition often occurs in the context of mental health disorders such as depression, anxiety, or substance abuse. Individuals experiencing suicidal ideation may feel overwhelmed by feelings of hopelessness and despair. The intensity and frequency of these thoughts can vary, and they may be accompanied by other symptoms like mood swings or withdrawal from social interactions. It is important to recognize that suicidal ideation is a serious condition that requires attention and support.

Trial ID:
2023-506329-12-00
Trial Phase:
Therapeutic exploratory (Phase II)

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