## Protocol Section
### Identification Module
**NCT ID:** NCT06430489

**Acronym:** PROTORISC

**Brief Title:** 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

#### Organization Study ID Info
**ID:** DR230123
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Tours
### Status Module
#### Completion Date
**Date:** 2026-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Tours

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Suicidal Ideation

- Emergency Psychiatric

- Nitrous Oxide

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Medical air

**Label:** Control

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Drug: Nitrous oxide

**Label:** Experimental

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental

**Description:** inhaled nitrous oxide (1 hour at 50% concentration)

**Name:** Nitrous oxide

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Control

**Description:** inhaled medical air (1 hour)

**Name:** Medical air

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Suicidal ideation severity decrease (SSI)

**Measure:** suicidal ideation severity

**Time Frame:** At Hour 4

#### Secondary Outcomes

**Description:** Suicidal ideation severity decrease (SSI): The score ranges from 0 to 38. The higher the total score, the greater the severity of suicide ideation

**Measure:** suicidal ideation severity

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

**Measure:** Suicidal ideation assessed by the SSI scale.

**Time Frame:** 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).

**Time Frame:** At Day 0 et Day 7

**Description:** The higher the total score, the greater the severity of depression

**Measure:** Depressive symptoms measured by hetero-assessment using the "Montgomery-Asberg Depression Rating Scale" (MADRS).

**Time Frame:** At Day 0 et Day 7

**Description:** The higher the total score, the greater the severity of depression

**Measure:** Depressive symptoms measured by the "Patient Health Questionnaire" PHQ-9 self-administered questionnaire.

**Time Frame:** At Day 0, At Hour 4, at Hour 24, at Hour 48 et at Day 7

**Description:** The higher the total score, the greater the severity of anxiety

**Measure:** Intensity of anxiety measured by the "State and Trait Anxiety Inventory" (STAI) scale.

**Time Frame:** At Day 0 up to Hour 4, at Hour 24, at Hour 48 et at Day 7

**Description:** The higher the score, the more the clinical condition has worsened

**Measure:** Overall improvement measured by change in Clinical Global Impression - Improvement (CGI) scale score.

**Time Frame:** At Day 0 up to Hour 4, at Hour 24, at Hour 48 et at Day 7

**Description:** Number of suicide attempts and methods in the month following the intervention

**Measure:** Commitment to suicidal action in the month following inclusion

**Time Frame:** in the month following Day 0

**Measure:** Consumption of psychotropic medication for anxiolytic or sedative purposes.

**Time Frame:** At Hour 0 up to Hour 4

### Eligibility Module

**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

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** anais.vandevelde@chu-tours.fr

**Name:** ANAIS VANDEVELDE, MD, PHD

**Phone:** +33247474747

**Role:** CONTACT

**Contact 2:**

**Email:** stellina.augis@chu-tours.fr

**Name:** Stellina AUGIS

**Phone:** 02.47.47.46.38

**Phone Ext:** +33

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tours

**Contacts:**

***Contact 1:***

- **Email:** anais.vandevelde@chu-tours.fr

- **Name:** ANAÏS VANDEVELDE, MD PhD

- **Phone:** 02.47.47.95.08

- **Phone Ext:** +33

- **Role:** CONTACT

**Country:** France

**Facility:** Psychiatric Emergencies

**Zip:** 37044

#### Overall Officials

**Official 1:**

**Affiliation:** CHRU de Tours

**Name:** ANAIS VANDEVELDE, MD, PHD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000013405

- Term: Suicide

- ID: D000016728

- Term: Self-Injurious Behavior

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M7796

- Name: Emergencies

- Relevance: HIGH

- As Found: Emergency

- ID: M29364

- Name: Suicidal Ideation

- Relevance: HIGH

- As Found: Suicidal Ideation

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M16191

- Name: Suicide

- Relevance: LOW

- As Found: Unknown

- ID: M19089

- Name: Self-Injurious Behavior

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004630

- Term: Emergencies

- ID: D000059020

- Term: Suicidal Ideation

### Intervention Browse Module - Ancestors

- ID: D000018685

- Term: Anesthetics, Inhalation

- ID: D000018681

- Term: Anesthetics, General

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M12546

- Name: Nitrous Oxide

- Relevance: HIGH

- As Found: Liver Transplantation

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M20765

- Name: Anesthetics, Inhalation

- Relevance: LOW

- As Found: Unknown

- ID: M20761

- Name: Anesthetics, General

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000009609

- Term: Nitrous Oxide

### Misc Info Module

- Version Holder: 2024-05-31
