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New treatment option for Suicidality
Official title Nitrous Oxide in the Treatment of Acute Suicidal Ideation
ClinicalTrials.gov ID: NCT06636357
What this study is testing
What is 50% N2O plus 50% O2?
50% N2O plus 50% O2 is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for suicidality.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary aim of the NITOS study is to investigate the potential rapid antisuicidal effects of N2O in the transdiagnostic treatment of suicidal ideation. On day 1, patients will receive either nitrous oxide (50% N2O balanced with oxygen) or placebo (50% oxygen balanced with air).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Ability to give written informed consent
- Moderate to severe suicidal ideation defined as a score ≥3 on the Montgomery-Asberg Depression Rating Scale (MADRS; Schmidtke et al., 1985) suicide...
- Plasma homocysteine level ≤ 14 µmol/l
You likely can't join if
- Organic, including symptomatic, mental disorders (F00-F09; lifetime diagnosis)
- Schizophrenia, schizotypal and delusional disorders (F20-F29; lifetime diagnosis)
- Mental and behavioral disorders due to psychoactive substance use. Nicotine and cannabis will be ignored (F10-F19)
- Non-medical (i.e., recreational) use of inhalational N2O during the last 12 months
- Past intolerance or hypersensitivity to N2O
- Critical illness
See the full eligibility criteria
- Ability to give written informed consent
- Moderate to severe suicidal ideation defined as a score ≥3 on the Montgomery-Asberg Depression Rating Scale (MADRS; Schmidtke et al., 1985) suicide item (item #10) as well as a self-report Beck Scale for Suicide...
- Plasma homocysteine level ≤ 14 µmol/l
- Organic, including symptomatic, mental disorders (F00-F09; lifetime diagnosis)
- Schizophrenia, schizotypal and delusional disorders (F20-F29; lifetime diagnosis)
- Mental and behavioral disorders due to psychoactive substance use. Nicotine and cannabis will be ignored (F10-F19)
- Non-medical (i.e., recreational) use of inhalational N2O during the last 12 months
- Past intolerance or hypersensitivity to N2O
- Critical illness
- Severe cardiac disease
- Pregnancy or breastfeeding
- Pulmonary hypertension
- Chronic cobalamin or folate deficiency unless treated with folic acid and/or vitamin B12
- History or evidence of any other medical or neurological condition that would expose the subject to an undue risk of a significant adverse event as determined by the clinical judgment of the investigator
- Treatment with ketamine/esketamine during the last 4 weeks
- Treatment with opioid medications during the last 3 months
- Treatment with vagus nerve stimulation (VNS) or electroconvulsive therapy (ECT) within the last 3 months
- Recent (within the last 4 weeks) or current use of benzodiazepines in excess of 5 mg lorazepam or equivalent per day
- Finally, any other factors that, in the investigator's judgment, would unduly impact patient safety or compliance during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.