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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
85
Inhalation of 50% N2O plus 50% O2 for 45 min
50% O2 plus 50% air for 45 min
Psychiatric University Hospital Zurich
Zurich, Switzerland
RECRUITINGBeck Scale for Suicidal Ideation (BSS)
Change of BSS score between Day 0 and Day 2. Double-blind treatment with either N2O or placebo inhalation on Day 1.
Time frame: Day 0 to Day 2
Montgomery-Åsberg Depression Rating Scale (MADRS )
Time frame: Day 0 to Day 2
EEG changes associated with N2O / placebo inhalation
EEG will be performed before, during, and after inhalation
Time frame: Day 1
Suicide Visual Analog Scale (S-VAS)
Briefly, the S-VAS uses the phrase "urge to kill myself". Next to the phrase, the patient sees a line that is anchored on the left with the word "none" and on the right with the word "extreme" . Score ranges from 0 to 100.
Time frame: Day 1
Perceived Burdensomeness Visual Analog Scale (PB-VAS)
The PB-VAS uses the phrase "like a burden". Next to the phrase, the patient sees a line that is anchored on the left with the word "none" and on the right with the word "extreme" . Score ranges from 0 to 100.
Time frame: Day 1
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