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NCT05528718 Clinical Trial

SMILE Trial - Imaging Sub-Study

Major Depressive Disorder Clinical Trial

Official title:
Sustained Mood Improvement With Laughing Gas Exposure: A Randomized Controlled Pilot Trial - Sub-Study Protocol to Include Neuroimaging

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05528718
Other study ID # 22-139
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 7, 2023
Est. completion date December 2024

Study information
Verified date May 2024
Source Unity Health Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a pilot sub-study of an ongoing trial comparing N2O to midazolam in MDD and will examine neuroimaging correlates of treatment response.

Description:

Magnetic resonance imaging (MRI) scans of MDD-affected brains have revealed changes in structural and functional connectivity compared to healthy subjects. This pilot sub-study examines structural and functional connectivity associated with MDD-affected patient participants' responsiveness to N2O compared to the midazolam placebo, which induces similar sedative effects. The investigators intend to address the changes in brain functional activity and connectivity between baseline and after a four-week intervention course involving weekly nitrous oxide inhalations measured by MRI.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 20
Est. completion date December 2024
Est. primary completion date August 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Eligible for main nitrous oxide (SMILE) study Exclusion Criteria: - Contraindication for undergoing MRI scans (e.g., hip circumference < 180 cm or metal in the body)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nitrous oxide gas for inhalation
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.
• Midazolam injection
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.

Locations
Country Name City State
Canada St. Michael's Hospital Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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