Trials Sponsors Conditions Drugs Pricing

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

Brain functional activity and connectivity
Changes in brain functional activity and connectivity between baseline and after 4 weeks of receiving the intervention, measured by MR imaging.
4 weeks from the baseline visit

Study Arms (2)

Experimental group

Participants assigned to this intervention arm in the main study will have been administered nitrous oxide at an inspiratory concentration of 50% with concurrent intravenous saline (100mL) for one hour.

Drug: Nitrous oxide gas for inhalation

Placebo group

Participants assigned to this intervention arm in the main study will have been administered 50% oxygen with intravenous midazolam (0.02mg/kg in 100mL) for one hour.

Drug: Midazolam injection

Interventions

Nitrous oxide gas for inhalationDrug

This sub-study does not have an intervention and based on the main study the participants who have received N2O will be compared with the midazolam placebo group.

Also known as: Nitrous oxide at an inspiratory concentration of 50% with concurrent intravenous saline (100mL)

Experimental group

Midazolam injectionDrug

This sub-study does not have an intervention and based on the main study the participants who have received N2O will be compared with the midazolam placebo group.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patient participants were diagnosed as suffering from major depressive disorder (MDD) that meets the criteria of the Diagnosis and Statistical Manual for Mental Disorders (DSM-5), will be eligible to participate in this data collection study. Participants who have agreed to receive N2O treatments as part of the Interventional Psychiatry Clinical Program at St. Michael's Hospital will be approached and recruited.

You may qualify if:

Sponsors & Collaborators

Unity Health Toronto
Otherlead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1M8, Canada

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Endothelium-Dependent Relaxing FactorsInhalationMidazolamOxygen

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Vasodilator AgentsCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

Venkat Bhat, MD MSc
Unity Health Toronto
PRINCIPAL INVESTIGATOR

Enrollment

11 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 6, 2022

Study Start

March 7, 2023

Actual (reported)

SMILE Trial - Imaging Sub-Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Experimental group

Placebo group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Experimental group

Placebo group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations