Nitrous Oxide in the Treatment of Acute Suicidal Ideation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Zurich
About this trial
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.
Eligibility criteria
Qualifiers
Ability to give written informed consent
Moderate to severe suicidal ideation defined as a score ≥3 on the Montgomery-Asberg Depression Rating Scale (MADRS; Schmidtke et al., 1985) suicide item (item #10) as well as a self-report Beck Scale for Suicide Ideation (BSS; Kliem et al., 2017) items #4 plus #5 score ≥ 2
Plasma homocysteine level ≤ 14 µmol/l
Disqualifiers
Organic, including 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. Nicotine and cannabis will be ignored (F10-F19)
Non-medical (i.e., recreational) use of inhalational N2O during the last 12 months
Trial design
Treatments tested in this trial
- 50% N2O plus 50% O2
- Oxygen (O2)
Treatment groups
85 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov