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
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AI-Summary
Official Title
Who Can Participate
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Trial Site Locations
Research Team
How is the study designed?
Frequently Asked Questions
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
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
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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1
2
3
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
Frequently Asked Questions
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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...