Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT06636357
Eligibility Criteria:
Inclusion criteria:
* 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
Exclusion criteria:
* 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
* 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
* History or evidence of any other medical or neurological condition that would expose the subject to an undue risk of a significant adverse event as determined by the clinical judgment of the 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 (within the last 4 weeks) or current use of benzodiazepines in excess of 5 mg lorazepam or equivalent per day
* Finally, any other factors that, in the investigator's judgment, would unduly impact patient safety or compliance during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06636357
Study Brief:
Protocol Section:
NCT06636357