Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
ID06636357

Nitrous Oxide in the Treatment of Acute Suicidal Ideation

Led by University of Zurich · Updated on 2025-01-16

85

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the potential rapid antisuicidal effects of nitrous oxide (N2O) in treating suicidal thoughts across different diagnoses. This Phase 2 study involves adults aged 18 to 65 with moderate to severe suicidal ideation. The trial aims to understand how N2O impacts suicidal ideation and to explore biological mechanisms using hair and blood samples, along with EEG recordings. Participants will receive inhalation treatments on two separate days. On day 1, they will receive either 50% nitrous oxide combined with 50% oxygen or a placebo of 50% oxygen plus 50% air for 45 minutes. This first inhalation is double-blind, meaning neither participants nor raters know the treatment assigned. Seven days later, all participants will receive nitrous oxide during the second inhalation, with only the patients blinded. A nested biomarker substudy will collect hair, blood, and EEG data to study mechanisms and prediction. During the trial, participants will undergo assessments including the Beck Scale for Suicidal Ideation (BSS) measured from day 0 to day 2, along with other scales like the Montgomery-Åsberg Depression Rating Scale and suicide-related visual analog scales. EEG changes linked to inhalation treatments will be recorded on day 1. Researchers will monitor safety and responses closely throughout. Total participation involves inhalation sessions, clinical ratings, and biological sample collections from the start through day 8.

CONDITIONS

Brief Title

Nitrous Oxide in the Treatment of Acute Suicidal Ideation

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to give written informed consent
  • Moderate to severe suicidal ideation defined as a score �3E=3 on the Montgomery-Asberg Depression Rating Scale suicide item and a self-report Beck Scale for Suicide Ideation items #4 plus #5 score �3E=2
  • Plasma homocysteine level �3C=14 bcmol/l
Not Eligible

You will not qualify if you...

  • 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 (excluding nicotine and cannabis)
  • Recreational use of inhalational nitrous oxide during the last 12 months
  • Past intolerance or hypersensitivity to nitrous oxide
  • Critical illness
  • Severe cardiac disease
  • Pregnancy or breastfeeding
  • Pulmonary hypertension
  • Chronic cobalamin or folate deficiency unless treated with folic acid and/or vitamin B12
  • Any other medical or neurological condition posing undue risk
  • Treatment with ketamine/esketamine during the last 4 weeks
  • Treatment with opioid medications during the last 3 months
  • Treatment with vagus nerve stimulation or electroconvulsive therapy within the last 3 months
  • Recent or current use of benzodiazepines in excess of 5 mg lorazepam or equivalent per day
  • Any other factors judged to impact safety or compliance adversely

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Single treatment session

Participants receive inhalation treatment with either 50% nitrous oxide plus 50% oxygen or 50% oxygen plus air for 45 minutes while blinded to the treatment assignment.

1 treatment visit (in-person)

Trial Site Locations

Total: 1 location

1

Psychiatric University Hospital Zurich

Zurich, Switzerland, 8032

Actively Recruiting

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Research Team

A

Angelina Frasch

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Inhalational nitrous oxide as a transdiagnostic approach for the treatment of suicidal ideation and suicidality in psychiatric inpatients: protocol for a double-blind randomised, controlled clinical single-centre trial.

Golo Kronenberg, Anna Bankwitz, Barbora Provaznikova...

https://pubmed.ncbi.nlm.nih.gov/40669910