Nitrous Oxide in the Treatment of Acute Suicidal Ideation
NCT06636357 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2025-01-16
Summary
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
- Suicidality
- EEG
- Suicidal Ideation
- Nitrous Oxide
- Biomarkers / Blood
- Biomarkers / Hair
Interventions
- DRUG
-
50% N2O plus 50% O2
Inhalation of 50% N2O plus 50% O2 for 45 min
- DRUG
-
Oxygen (O2)
50% O2 plus 50% air for 45 min
Sponsors & Collaborators
-
University of Zurich
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-13
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
Countries
- Switzerland
Study Locations
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