Actively Recruiting

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

Nitrous Oxide in the Treatment of Acute Suicidal Ideation A Randomized, Placebo-Controlled Study Evaluating Rapid Effects and Biomarkers

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

Researchers are studying the potential fast-acting effects of nitrous oxide (N2O) in treating suicidal thoughts across different diagnoses. This Phase 2 trial focuses on adults aged 18 to 65 who have moderate to severe suicidal ideation. The study also explores biological markers using hair and blood samples and brain activity through EEG to understand how the treatment works and predict outcomes. Participants will receive two inhalation treatments during the study. On the first day, they will be randomly given either 50% nitrous oxide mixed with oxygen or a placebo of 50% oxygen mixed with air for 45 minutes. Seven days later, all participants will receive nitrous oxide in an open-label second inhalation. The first inhalation is double-blind, meaning neither patients nor raters know the assignment, but only patients are blinded during the second inhalation. Throughout the study, participants will be evaluated for changes in suicidal thoughts using the Beck Scale for Suicidal Ideation from the start to two days after treatment. Researchers will collect biological samples and perform EEG tests to examine the treatment's effects and mechanisms. Safety and participant compliance will be closely monitored, with the total duration including the initial treatment and follow-up assessments.

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

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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

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
Nitrous Oxide in the Treatment of Acute Suicidal Ideation A Randomized, Placebo-Controlled Study Evaluating Rapid Effects and Biomarkers | DecenTrialz