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NMDA antagonist

Nitrous Oxide for Suicidal Thoughts

Phase 1
Waitlist Available
Led By Charles R Conway, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged 18-65 years old;
Current diagnosis of unipolar, major depressive disorder (MDD) without psychosis as defined by the Mini-International Neuropsychiatric Interview (MINI) and The Fourth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) DSM-IV determined by clinical interview and by a baseline score of ≥18 on the HDRS-21 (Hamilton Depression Rating Scale 21-item)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 7, approximately 7 days (following the inpatient period inhalation sessions)
Awards & highlights

Study Summary

This trial is designed to study whether nitrous oxide, a gas that people sometimes use for short-term pain relief, can help people with treatment-resistant depression who are also experiencing suicidal thoughts.

Who is the study for?
This trial is for adults aged 18-65 with major depressive disorder without psychosis, experiencing acute suicidal thoughts. They must score ≥18 on the HDRS-21 scale and be admitted voluntarily to a specific hospital's inpatient Psychiatric Units. Excluded are those with certain psychiatric diagnoses, recent NMDA antagonist treatment, severe personality disorders, significant pulmonary disease, past head trauma or substance abuse.Check my eligibility
What is being tested?
The study tests if inhaling nitrous oxide can help reduce suicidal thoughts in patients with treatment-resistant depression. It compares standard treatments plus nitrous oxide inhalation against standard treatments plus placebo gas over several sessions both as inpatients and outpatients.See study design
What are the potential side effects?
Nitrous oxide may cause side effects like nausea, dizziness, headache, or increased risk of vitamin B12 deficiency which could lead to nerve damage if used frequently or long-term.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with major depression without psychosis.
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I have been diagnosed with major depression without psychosis.
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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 7, approximately 7 days (following the inpatient period inhalation sessions)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 7, approximately 7 days (following the inpatient period inhalation sessions) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Differential change in suicidal ideation
Identification of pre-treatment key clinical correlates of anti-suicidal response to nitrous oxide
Severity and number of adverse events in both nitrous oxide and placebo groups

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nitrous OxideExperimental Treatment1 Intervention
Nitrous oxide, an odorless, colorless gas typically used as an induction agent for general anesthesia or for dental sedation, is a known N-methyl-D-aspartate (NMDA) antagonist. It will be given at 50% nitrous oxide/50% oxygen in this study. Participants will undergo a maximum of four one hour inhalation sessions as inpatients and 2 booster sessions as outpatients during which they will receive inhaled nitrous oxide.
Group II: Placebo GasPlacebo Group1 Intervention
Placebo gas given at 50% nitrogen [inert]/50% oxygen. Participants will undergo a maximum of four one hour inhalation sessions as inpatients and 2 booster sessions as outpatients during which they will receive placebo gas.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitrous Oxide
2016
Completed Phase 4
~8380

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,823 Total Patients Enrolled
68 Trials studying Depression
23,329 Patients Enrolled for Depression
American Foundation for Suicide PreventionOTHER
33 Previous Clinical Trials
9,725 Total Patients Enrolled
9 Trials studying Depression
5,802 Patients Enrolled for Depression
Charles R Conway, MDPrincipal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
92 Total Patients Enrolled
2 Trials studying Depression
92 Patients Enrolled for Depression

Media Library

Nitrous Oxide (NMDA antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03736538 — Phase 1
Depression Research Study Groups: Nitrous Oxide, Placebo Gas
Depression Clinical Trial 2023: Nitrous Oxide Highlights & Side Effects. Trial Name: NCT03736538 — Phase 1
Nitrous Oxide (NMDA antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03736538 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other experiments that have explored the effects of Nitrous Oxide?

"Currently, there is one phase 3 trial and 11 other active studies being conducted on Nitrous Oxide. Despite mainly occurring in Saint Louis, Missouri, these clinical trials are taking place at 12 different medical centres across the United States of America."

Answered by AI

Are any individuals younger than 40 years old eligible for enrollment in the research?

"According to the requirements of this research, individuals aged between 18 and 65 are eligible for inclusion."

Answered by AI

Is this experiment seeking participants at the present time?

"Unfortunately, this research trial is no longer recruiting patients at this time. It was initially posted on October 30th 2018 and most recently updated details were released on July 27th 2022. If you are trying to join a different clinical study, there are currently 2124 trials for suicidal ideation that require participants and 12 studies involving Nitrous Oxide need additional volunteers."

Answered by AI

Has the Federal Drug Administration authorized Nitrous Oxide for medical use?

"Due to its Phase 1 status, where there is limited safety and efficacy data available, Nitrous Oxide was assigned a score of 1 by our team at Power."

Answered by AI

What is the aggregate enrollment rate for this experiment?

"Recruitment for this trial is closed, with the initial posting date on October 30th 2018 and last updated July 27 2022. However, should you search for other studies there are currently 2124 trials that accept participants suffering from suicidal ideation as well as 12 involving Nitrous Oxide in progress."

Answered by AI

Could I be a qualified participant in this research endeavor?

"This study calls for 50 volunteers, aged 18-65 years old and suffering from unipolar major depressive disorder (MDD) without psychosis as evidenced by MINI and DSM-IV tests that produce a score of ≥18 on the HDRS-21. Furthermore, these patients must present with moderate to severe suicidal ideation as indicated by an associated HDRS-21 suicide item #3 rating of 3 or higher. These qualifications are in addition to admission into the Barnes Jewis Hospital/Washington University's Psychiatric Unit located in St Louis Missouri."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Tennessee
How old are they?
18 - 65
What site did they apply to?
Washington University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Nitrous Oxide- Suicidal Ideation
2018. "Nitrous Oxide- Suicidal Ideation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03736538.
All > Major Depressive Disorder > Treatment Resistant Depression
~1 spots leftby Jun 2024
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