Nitrous Oxide for Depression
(SMILE Trial)
Not yet recruiting at 4 trial locations
AC
Overseen ByAnesthesia Clinical Trials Unit
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Women's College Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
What You Need to Know Before You Apply
What is the purpose of this trial?
Multi-centre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of nitrous oxide on reducing symptoms of depression in patients with treatment resistant depression.
Who Is on the Research Team?
KL
Karim Ladha, MD
Principal Investigator
Women's College Hospital
Are You a Good Fit for This Trial?
This trial is for individuals with treatment-resistant major depressive disorder, meaning their depression hasn't improved after trying other treatments. Specific eligibility details are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.Inclusion Criteria
Meeting Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria for Major Depressive Disorder (MDD)
I am between 18 and 65 years old.
I have been diagnosed with a major depressive episode.
See 4 more
Exclusion Criteria
Acute suicidality defined as score > 4 on MADRS item 10
Current or lifetime history of schizophrenia or schizoaffective disorder
Known history of hypersensitivity or allergy to nitrous oxide, midazolam or any ingredients in the study formulations
See 12 more
What Are the Treatments Tested in This Trial?
Interventions
- Nitrous Oxide
Trial Overview The study tests if inhaling laughing gas (nitrous oxide) combined with an IV saline solution can reduce depression symptoms compared to inhaling pure oxygen paired with an IV of midazolam, a sedative. Participants are randomly assigned to one of these two options in equal numbers without knowing which one they receive.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Nitrous oxide at an inspiratory concentration of 50% with concurrent intravenous saline (20ml) for one hour.
Group II: Active Control GroupActive Control1 Intervention
Inspiration of 100% oxygen with concurrent intravenous midazolam (0.02mg/kg, up to 2 mg) for one hour.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Women's College Hospital
Lead Sponsor
Trials
108
Recruited
43,700+
Anesthesia Clinical Trials Unit (Department of Anesthesia and Pain Management)
Collaborator
University Health Network, Toronto
Collaborator
Trials
1,555
Recruited
526,000+
Sunnybrook Health Sciences Centre
Collaborator
Trials
693
Recruited
1,569,000+
Unity Health Toronto
Collaborator
Trials
572
Recruited
470,000+
Canadian Institutes of Health Research (CIHR)
Collaborator
Trials
1,417
Recruited
26,550,000+
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