Suicidal IdeationPhase 2PROTORISCNCT06430489
Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide
A Phase 2 study testing Nitrous oxide and Medical air in people with Suicidal Ideation and Emergency Psychiatric, run by University Hospital, Tours at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Suicidal Ideation, Emergency Psychiatric, Nitrous Oxide
- What is being tested?
- Nitrous oxide and Medical air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2024to Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Psychiatric Emergencies
Tours, 37044
ANAÏS VANDEVELDE, MD PhD, 02.47.47.95.08 ext. +33, anais.vandevelde@chu-tours.fr
About this study
Official title: Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide - PROTORISC Pilote
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
- Suicidal Ideation, Emergency Psychiatric, Nitrous Oxide
- Being tested
- Nitrous oxide, Medical air
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous oxideDrug
inhaled nitrous oxide (1 hour at 50% concentration)
Medical airDrug
inhaled medical air (1 hour)
| Study group | Role | What they receive |
|---|---|---|
| Medical air administration | Placebo comparator | Not described Receives: Drug: Medical air |
| Nitrous oxide administration | Experimental | Not described Receives: Drug: Nitrous oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
suicidal ideation severity
Suicidal ideation severity decrease (SSI)
Measured: At Hour 4
Secondary outcomes (9)
suicidal ideation severity
Suicidal ideation severity decrease (SSI): The score ranges from 0 to 38. The higher the total score, the greater the severity of suicide ideation
Measured: At Hour 24, at Hour 48, at Day 7 and at Month 1
Suicidal ideation assessed by the SSI scale.
Measured: At Hour 24, at Hour 48, at Day 7 and at Month 1
Suicidal ideation assessed by the Columbia Suicidal Risk Severity Scale (C-SSRS).
Measured: At Day 0 and Day 7
Depressive symptoms measured by hetero-assessment using the "Montgomery-Asberg Depression Rating Scale" (MADRS).
The higher the total score, the greater the severity of depression
Measured: At Day 0 and Day 7
Depressive symptoms measured by the "Patient Health Questionnaire" PHQ-9 self-administered questionnaire.
The higher the total score, the greater the severity of depression
Measured: At Day 0, At Hour 4, at Hour 24, at Hour 48 and at Day 7
Intensity of anxiety measured by the "State and Trait Anxiety Inventory" (STAI) scale.
The higher the total score, the greater the severity of anxiety
Measured: At Day 0 up to Hour 4, at Hour 24, at Hour 48 and at Day 7
Overall improvement measured by change in Clinical Global Impression - Improvement (CGI) scale score.
The higher the score, the more the clinical condition has worsened
Measured: At Day 0 up to Hour 4, at Hour 24, at Hour 48 and at Day 7
Commitment to suicidal action in the month following inclusion
Number of suicide attempts and methods in the month following the intervention
Measured: in the month following Day 0
Consumption of psychotropic medication for anxiolytic or sedative purposes.
Measured: At Hour 0 up to Hour 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study startJun 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANAIS VANDEVELDE, MD, PHD, Principal investigator, CHRU de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430489
- Sponsor's protocol ID
- DR230123
- Acronym
- PROTORISC
- Status last verified
- May 2024
- First submitted
- 26 Apr 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide - PROTORISC Pilote
- ClinicalTrials.gov ID
- NCT06430489
- Acronym / sponsor ID
- PROTORISC / DR230123
- Conditions
- Suicidal Ideation, Emergency Psychiatric, Nitrous Oxide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical air administration | Placebo comparator | Drug: Medical air |
| Nitrous oxide administration | Experimental | Drug: Nitrous oxide |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous oxideinhaled nitrous oxide (1 hour at 50% concentration) | Drug | Nitrous oxide administration |
| Medical airinhaled medical air (1 hour) | Drug | Medical air administration |
Primary outcome
suicidal ideation severity
Time frame: At Hour 4
Suicidal ideation severity decrease (SSI)
9 secondary outcomes
suicidal ideation severity
Time frame: At Hour 24, at Hour 48, at Day 7 and at Month 1
Suicidal ideation assessed by the SSI scale.
Time frame: At Hour 24, at Hour 48, at Day 7 and at Month 1
Suicidal ideation assessed by the Columbia Suicidal Risk Severity Scale (C-SSRS).
Time frame: At Day 0 and Day 7
Depressive symptoms measured by hetero-assessment using the "Montgomery-Asberg Depression Rating Scale" (MADRS).
Time frame: At Day 0 and Day 7
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 and at Day 7
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 and at Day 7
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 and at Day 7
Commitment to suicidal action in the month following inclusion
Time frame: in the month following Day 0
Consumption of psychotropic medication for anxiolytic or sedative purposes.
Time frame: At Hour 0 up to Hour 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANAIS VANDEVELDE, MD, PHD principal investigator
CHRU de Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitrous oxide and Medical air in people with Suicidal Ideation and Emergency Psychiatric, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANAIS VANDEVELDE, MD, PHD (+33247474747, anais.vandevelde@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
suicidal ideation severity (time frame: At Hour 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.