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Nitrous Oxide for Depression

Phase 2

Recruiting

Led By Peter Nagele, MD, MSc

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

DSM-5 criteria for MDD without psychosis, as determined using a structured clinical interview [Mini International Neuropsychiatric Interview], MDD, defined by a pre-treatment score >16 on the HDRS-21 scale and meeting DSM-5 for MDD

Adult (≥18 years, both sexes)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 24-hours (following treatment-1)

Awards & highlights

Study Summary

This trial is testing whether nitrous oxide can help treat depression, and what the best dose and regimen is.

Who is the study for?

This trial is for adults with major depressive disorder (MDD), confirmed by specific criteria and a score >16 on the HDRS-21 scale. Participants must not have psychosis, recent substance abuse (except nicotine), ongoing ECT treatment, significant medical issues, or be pregnant/breastfeeding. Those with suicidal intentions, bipolar disorder, schizophrenia, panic disorder or certain other mental health conditions are excluded.Check my eligibility

What is being tested?

The study tests the antidepressant effects of nitrous oxide gas compared to a placebo in people with MDD. It aims to find the best dose and usage pattern for nitrous oxide to improve depression symptoms quickly and sustainably as preparation for a larger future trial.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects of inhaling nitrous oxide can include dizziness, nausea, headache, increased sleepiness or euphoria. Long-term use may lead to vitamin B12 deficiency which could cause nerve damage if untreated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with major depression without psychosis.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 24-hours (following treatment-1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 24-hours (following treatment-1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24-hours (following treatment-1) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in HDRS-21 score

Secondary outcome measures

Changes in 'Profile of Mood States' scores

Changes in Computerize Adaptive Testing - Mental Health (CAT-MH) 'anxiety' scores

Changes in Computerize Adaptive Testing - Mental Health (CAT-MH) 'depression' scores

+8 more

Other outcome measures

Adverse Events

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Treatment; Nitrous Oxide 50% or 25%, groupActive Control1 Intervention

Four-weekly, 60-minute inhalation sessions of 25% or 50% nitrous oxide, randomly assigned.

Group II: Control; Oxygen-air mixture, groupPlacebo Group1 Intervention

Four-weekly, 60-minute inhalation sessions of an oxygen and air mixture.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The AlfredOTHER

107 Previous Clinical Trials

10,044,693 Total Patients Enrolled

7 Trials studying Depression

417 Patients Enrolled for Depression

University of ChicagoLead Sponsor

1,002 Previous Clinical Trials

817,678 Total Patients Enrolled

18 Trials studying Depression

11,087 Patients Enrolled for Depression

Peter Nagele, MD, MScPrincipal InvestigatorUniversity of Chicago, Department of Anesthesia and Critical Care

4 Previous Clinical Trials

621 Total Patients Enrolled

2 Trials studying Depression

71 Patients Enrolled for Depression

Media Library

Nitrous Oxide (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05357040 — Phase 2

Depression Research Study Groups: Treatment; Nitrous Oxide 50% or 25%, group, Control; Oxygen-air mixture, group

Depression Clinical Trial 2023: Nitrous Oxide Highlights & Side Effects. Trial Name: NCT05357040 — Phase 2

Nitrous Oxide (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05357040 — Phase 2

Frequently Asked Questions

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

How many individuals are included in this experiment?

"That is correct, the listed clinical trial on clinicaltrials.gov is still looking for patients. The study was made public on June 30th 2021 and has had one update since then on April 26th 2022. There is a total goal of 172 enrollees at 1 medical facility."

Answered by AI

Are there any patients still needed for this research project?

"This trial, which was first posted on June 30th 2021, is ongoing and presently recruiting patients according to the latest update from clinicaltrials.gov on April 26th 2022."

Answered by AI

What are the FDA-cleared percentages of nitrous oxide for different medical treatments?

"While there is some evidence to support the safety of this treatment, as it is only a Phase 2 trial, not enough data exists yet to confirm its efficacy. Therefore, we have given it a score of 2."

Answered by AI