Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT06636357

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

89 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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). Seven days after the first inhalation, a second inhalation will be performed. All patients will receive N2O at least once during this trial. While the first inhalation will be double-blind, only the patients but not the raters will be blinded to the second inhalation (day 8). For mechanism of action and prediction, a nested biomarker substudy will employ multimodal techniques including analysis of hair and blood samples, and EEG.

CONDITIONS

Official 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  on the Montgomery-Asberg Depression Rating Scale (MADRS) suicide item and a self-report Beck Scale for Suicide Ideation (BSS) items #4 plus #5 score  2
  • Plasma homocysteine level  14 mol/l
Not Eligible

You will not qualify if you...

  • Organic or 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 except nicotine and cannabis (F10-F19)
  • Non-medical 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
  • Any other medical or neurological condition posing undue risk as judged by 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 or current use of benzodiazepines exceeding 5 mg lorazepam or equivalent per day
  • Any other factors impacting patient safety or compliance as judged by investigator

AI-Screening

AI-Powered Screening

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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

CONTACT

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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