Studying Nitrous Oxide as a Treatment for Severe Suicidal Thoughts in Adults Aged 18 to 65
Led by University of Zurich · Updated on 2025-01-16
85
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the potential rapid antisuicidal effects of nitrous oxide N2O in treating suicidal thoughts across different diagnoses. This Phase 2 study involves adults aged 18 to 65 with moderate to severe suicidal ideation. The trial aims to understand how N2O impacts suicidal ideation and to explore biological mechanisms using hair and blood samples, along with EEG recordings.
Participants will receive inhalation treatments on two separate days. On day 1, they will receive either 50% nitrous oxide combined with 50% oxygen or a placebo of 50% oxygen plus 50% air for 45 minutes. This first inhalation is double-blind, meaning neither participants nor raters know the treatment assigned. Seven days later, all participants will receive nitrous oxide during the second inhalation, with only the patients blinded. A nested biomarker substudy will collect hair, blood, and EEG data to study mechanisms and prediction.
During the trial, participants will undergo assessments including the Beck Scale for Suicidal Ideation BSS measured from day 0 to day 2, along with other scales like the Montgomery-sberg Depression Rating Scale and suicide-related visual analog scales. EEG changes linked to inhalation treatments will be recorded on day 1. Researchers will monitor safety and responses closely throughout. Total participation involves inhalation sessions, clinical ratings, and biological sample collections from the start through day 8.
CONDITIONS
Brief Title
Nitrous Oxide in the Treatment of Acute Suicidal Ideation
Research Team
A
Angelina Frasch
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Moderate to severe suicidal ideation defined as a score �3E=3 on the Montgomery-Asberg Depression Rating Scale suicide item and a self-report Beck Scale for Suicide Ideation items #4 plus #5 score �3E=2
Plasma homocysteine level �3C=14 bcmol/l
You will not qualify if you...
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 (excluding nicotine and cannabis)
Recreational use of inhalational nitrous oxide during the last 12 months
Past intolerance or hypersensitivity to nitrous oxide
Critical illness
Severe cardiac disease
Pregnancy or breastfeeding
Pulmonary hypertension
Chronic cobalamin or folate deficiency unless treated with folic acid and/or vitamin B12
Any other medical or neurological condition posing undue risk
Treatment with ketamine/esketamine during the last 4 weeks
Treatment with opioid medications during the last 3 months
Treatment with vagus nerve stimulation or electroconvulsive therapy within the last 3 months
Recent or current use of benzodiazepines in excess of 5 mg lorazepam or equivalent per day
Any other factors judged to impact safety or compliance adversely
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Single treatment session
Participants receive inhalation treatment with either 50% nitrous oxide plus 50% oxygen or 50% oxygen plus air for 45 minutes while blinded to the treatment assignment.
1 treatment visit (in-person)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Evaluating Attachment Based Family Therapy to Reduce Suicidal Thoughts and Behavior in Young Adults Compared to Standard Treatment
Peer-Delivered Recovery-Focused Suicide Prevention Program for Veterans with Serious Mental Illness
Brain Stimulation Treatment Using Accelerated Intermittent Theta Burst Stimulation for Depression and Suicidal Thoughts in Adolescents and Young Adults Aged 15 to 25
Safety and Acceptability of Two Psilocybin Doses with Therapy for Bipolar II Depression and Suicidal Thoughts
Study of Low-Dose Buprenorphine Added to Usual Treatment for Reducing Severe Suicidal Thoughts in Adults with Major Depression
Evaluating Suicide Intervention Methods for Teens Aged 11 to 17 During High Risk Periods
Safety and Effectiveness of Accelerated Intermittent Theta Burst Stimulation for Reducing Self-Injury and Suicidal Behaviors in Adolescents with Major Depression
Study of Suicidal Behavior in Children and Adolescents Aged 8 to 18 During the Covid-19 Pandemic in Auvergne-Rhne-Alpes Region
Randomized Trial Comparing Two Behavioral Therapies for Improving Mood and Sleep in Adults 55 and Older with Depression and Suicide Risk
Study of Crisis Response Planning to Help Reduce Suicidal Thoughts in Active Duty Military Members
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Inhalational nitrous oxide as a transdiagnostic approach for the treatment of suicidal ideation and suicidality in psychiatric inpatients: protocol for a double-blind randomised, controlled clinical single-centre trial.
Golo Kronenberg, Anna Bankwitz, Barbora Provaznikova...