drugset / Trial / NCT06636357

Nitrous Oxide in the Treatment of Acute Suicidal Ideation

NCT06636357

Phase 2 Recruiting 85 enrolled University of Zurich
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-01-13
Primary completion
2026-09-30
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitrous Oxide Other / unclassified 50 % Inhaled
Background 50% N2O plus 50% O2 Unknown 50 % Inhaled