Treatment; Nitrous Oxide 50% or 25%, group for Depressive Disorder, Treatment-Resistant

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
The Alfred Hospital, Melbourne, Australia
Depressive Disorder, Treatment-Resistant+5 More
Nitrous oxide gas for inhalation - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

To evaluate the acute and sustained antidepressant effects of nitrous oxide in people with major depressive disorder; and further evaluate these effects by identifying the optimal dose and regimen to guide current practice, and to plan a future large pragmatic trial.

Eligible Conditions

  • Depressive Disorder, Treatment-Resistant
  • Major Depressive Disorder (MDD)
  • Unipolar Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Depressive Disorder, Treatment-Resistant

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: At 24-hours (following treatment-1)

At 24-hours (following treatment-1)
Treatment remission
Treatment response
At Baseline (Prior to treatment-1)
Visual Analog Scale (VAS)
Over 4-weeks (weekly treatment sessions)
Treatment cycle compliance
Over 4-weeks from baseline
Change in HDRS-21 score
Over 7-weeks (length of study participation)
Treatment dose response comparison
Over 7-weeks (length of study participation) from Baseline
Changes in Computerize Adaptive Testing - Mental Health (CAT-MH) 'anxiety' scores
Changes in Computerize Adaptive Testing - Mental Health (CAT-MH) 'depression' scores
Changes in Computerize Adaptive Testing - Mental Health (CAT-MH) 'suicide' scores
Suicidal ideation tracking
Over 7-weeks (length of study participation).
Adverse Events
Sustainability of treatment response
Up to 1-week (following treatment-1)
Changes in 'Profile of Mood States' scores

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Depressive Disorder, Treatment-Resistant

Trial Design

2 Treatment Groups

Treatment; Nitrous Oxide 50% or 25%, group
1 of 2
Control; Oxygen-air mixture, group
1 of 2
Active Control
Non-Treatment Group

172 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment; Nitrous Oxide 50% or 25%, group · Has Placebo Group · Phase 2

Treatment; Nitrous Oxide 50% or 25%, group
Drug
ActiveComparator Group · 1 Intervention: Nitrous oxide gas for inhalation · Intervention Types: Drug
Control; Oxygen-air mixture, group
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 24-hours (following treatment-1)
Closest Location: University of Chicago Medicine · Chicago, IL
Photo of Chicago 1Photo of Chicago 2Photo of Chicago 3
2011First Recorded Clinical Trial
1 TrialsResearching Depressive Disorder, Treatment-Resistant
45 CompletedClinical Trials

Who is running the clinical trial?

University of ChicagoLead Sponsor
909 Previous Clinical Trials
726,725 Total Patients Enrolled
The AlfredOTHER
99 Previous Clinical Trials
41,800 Total Patients Enrolled
1 Trials studying Depressive Disorder, Treatment-Resistant
15 Patients Enrolled for Depressive Disorder, Treatment-Resistant
Peter Nagele, MD, MScPrincipal InvestigatorUniversity of Chicago, Department of Anesthesia and Critical Care
2 Previous Clinical Trials
71 Total Patients Enrolled
Paul Myles, MDPrincipal InvestigatorThe Alfred Hospital, Department of Anesthesiology and Perioperative Medicine
1 Previous Clinical Trials
172 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a pre-treatment score of 16 or more on the Hamilton Depression Rating Scale-21 (HDRS-21)

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References